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BIOPHARMACEUTICAL REPORT

Current Issue: Biopharmaceutical Report
Volume 15, No. 2 --- Summer 2007
Editors: Richard Caplan, Philip Pichotta, Thomas Dobbins


Contents

FEATURED ARTICLES
  • Model-Based Drug Development - A New Paradigm for Efficient Drug
    Development -- Kenneth G. Kowalski, Wayne Ewy, Matthew M. Hutmacher,
    Raymond Miller, and Sriram Krishnaswami
BIOPHARMACEUTICAL SECTION NEWS
  • Note from the Editors
  • Letter from the Chair -- Brian Wiens
  • Biopharmaceutical Section Members Elected ASA Fellows -- Keith Soper
  • Highlights of the Biopharmaceutical Section Executive
    Committee Meeting, Atlanta, Georgia, March 12, 2007 -- Brian Wiens
  • Biopharmaceutical Section Program for JSM 2007 -- Amit Bhattacharyya
  • 2007 FDA/Industry Workshop,
    September 17-19, Arlington, VA -- Dionne Price and Matilde Sanchez
  • Let's hear from you




Previous Issues: [as PDF files]

 


Title Authors Volume-Issue Number Date Page
Personal News Vol 1, No. 2 Summer 1992 6
Editor's Note Alemayehu, Demissie Vol 8, No. 2 Fall 2000 1
Editor's Note Alemayehu, Demissie Vol 8, No. 3 Winter 2000 1
Note from the Editors Alemayehu, Demissie , David Giltinan, Kevin W. Anderson Vol 13, No. 1 Winter 2005 1
Note from the Editors Alemayehu, Demissie , David Giltinan, Kevin W. Anderson Vol 13, No. 2 Spring 2005 1
Adaptive Designs in Clinical Trials: Lilly Experience - Discussion Al-Osh, M. Vol 3, No. 1 Summer 1995 9
Review of: Practical Statistics for Medical Research Ames, Michael Vol 5, No. 1 Winter 1997 7
Adaptive Designs in Clinical Trials: Lilly Experience Andersen, John S., Douglas E. Faries, Roy N. Tamura Vol 3, No. 1 Summer 1995 1
Adaptive Designs in Clinical Trials: Lilly Experience - Rejoinder Andersen, John S., Douglas E. Faries, Roy N. Tamura Vol 3, No. 1 Summer 1995 11
Note from the Editors on FDA Draft Guidance on Clinical Trial Data Monitoring Committees Anderson, Kevin W. Vol 10, No. 1 Spring 2002 1
Forward (Statistical Analysis Plans) Anderson, Kevin W. Vol 10, No. 2 Winter 2002 1
Note from the Editors Anderson, Kevin W., Demissie Alemayehu, David Giltinan Vol 13, No. 1 Winter 2005 1
Note from the Editors Anderson, Kevin W., Demissie Alemayehu, David Giltinan Vol 13, No. 2 Spring 2005 1
Minutes of August 20, 1991, ASA Biopharmaceutical Section Business Meeting Anderson, Sharon Vol 1, No. 2 Summer 1992 8
Individual Bioequivalence: A Problem of Switchability Anderson, Sharon Vol 2, No. 2 Winter 1993 1
Individual Bioequivalence: A Problem of Switchability - Rejoinder Anderson, Sharon Vol 2, No. 2 Winter 1993 10
Common Challenges Facing Statisticians in Nonclinical Biostatistics - Discussion Arseven, Ersen Vol 7, No. 2 Summer 1999 7
Biopharmaceutical Section Roundtables, JSM 1998, Dallas, Texas: Statistical Analysis in Outcomes and Pharmacoeconomic Studies Barker, Christopher M. Vol 7, No. 1 Spring 1999 23
Common Challenges Facing Statisticians in Nonclinical Biostatistics Bergum, James Vol 7, No. 2 Summer 1999 1
1996 JSM Round Table Luncheon Discussions: Bayesian Methods and Ideas in Medical Research Berry, Donald A. Vol 5, No. 3 Fall/Winter 1997 23
Adaptive Trials and Bayesian Statistics in Drug Development Berry, Donald A. Vol 9, No. 2 Winter 2001 1
Rejoinder to discussants George Chi, H. M. James Hung, Robert O'Neill Berry, Donald A. Vol 9, No. 2 Winter 2001 10
Biopharmaceutical Section Program for JSM 2007 Bhattacharyya, Amit Vol 15, No. 2 Summer 2007 24
Minutes of the ASA Biopharm Executive Committee Meeting at JSM 2004 at Toronto, Canada Bhattacharyya, Amit Vol 13, No. 1 Winter 2005 9
JSM 2006 Luncheon Roundtables Bhattacharyya, Amit Vol 14, No. 2 Summer 2006 12
ASA Biopharmaceutical Section Executive Committee - 1992 Biopharmaceutical Section Executive Committee Vol 1, No. 1 Winter 1992 15
Best Presentation of a Contributed Paper, ASA 1991 Biopharmaceutical Section Executive Committee Vol 1, No. 1 Winter 1992 4
Midwest Biopharmaceutical Statistics Workshop, Muncie, Indiana, May 22 to May 24, 1991 Biopharmaceutical Section Executive Committee Vol 1, No. 1 Winter 1992 5
Sessions Sponsored by the Biopharmaceutical Section at the 1992 ENAR Spring Meeting Biopharmaceutical Section Executive Committee Vol 1, No. 1 Winter 1992 3
ASA Biopharmaceutical Section Executive Committee - 1992 Biopharmaceutical Section Executive Committee Vol 1, No. 2 Summer 1992 19
ASA Biopharmaceutical Section Executive Committee - 1993 Biopharmaceutical Section Executive Committee Vol 1, No. 3 Fall 1992 18
Biopharmaceutical Section-Sponsored Sessions at ENAR Meeting, March 21-24, 1993 in Philadelphia, Pennsylvania Biopharmaceutical Section Executive Committee Vol 1, No. 3 Fall 1992 20
Sessions at the Joint Statistical Meetings Sponsored by the Biopharmaceutical Section in Boston, August 1992 Biopharmaceutical Section Executive Committee Vol 1, No. 3 Fall 1992 13
Continuing Education Program Seeks Student Monitors for Continuing Education Courses at JSM Biopharmaceutical Section Executive Committee Vol 10, No. 1 Spring 2002 5
Meeting Minutes Biopharmaceutical Section Executive Committee Transition Meeting Thursday, Dec. 12, 2002, ASA Headquarters Biopharmaceutical Section Executive Committee Vol 10, No. 2 Winter 2002 10
The 26th Annual Midwest Biopharmaceutical Statistics Workshop, May 19-21, 2003 Biopharmaceutical Section Executive Committee Vol 10, No. 2 Winter 2002 8
Electronic Distribution of Biopharmaceutical Report Biopharmaceutical Section Executive Committee Vol 11, No. 1 Spring 2003 1
2003 Biopharmaceutical Section Corporate Sponsors Biopharmaceutical Section Executive Committee Vol 11, No. 2 Winter 2003 1
Electronic Distribution of Biopharmaceutical Report Biopharmaceutical Section Executive Committee Vol 11, No. 2 Winter 2003 1
Minutes - Biopharmaceutical Section Executive Meeting, ENAR at Tampa, Florida, 1-April 2003 Biopharmaceutical Section Executive Committee Vol 11, No. 2 Winter 2003 9
2004 Biopharmaceutical Section Corporate Sponsors Biopharmaceutical Section Executive Committee Vol 12, No. 1 Spring 2004 7
The 27th Annual Midwest Biopharmaceutical Statistics Workshop, May 24-26, 2004 Biopharmaceutical Section Executive Committee Vol 12, No. 1 Spring 2004 8
The 29th Annual Midwest Biopharmaceutical Statistics Workshop Biopharmaceutical Section Executive Committee Vol 14, No. 1 Winter 2006 10
ASA Biopharmaceutical Section Executive Committee - 1993 Biopharmaceutical Section Executive Committee Vol 2, No. 1 Summer 1993 18
Election Results Biopharmaceutical Section Executive Committee Vol 2, No. 1 Summer 1993 20
Minutes of the August 10, 1992, ASA Biopharmaceutical Section Business Meeting Biopharmaceutical Section Executive Committee Vol 2, No. 1 Summer 1993 13
Section-sponsored Sessions at ASAS Joint Meetings, August 1993 Biopharmaceutical Section Executive Committee Vol 2, No. 1 Summer 1993 17
ASA Biopharmaceutical Section Executive Committee & Section Representatives - 1994 Biopharmaceutical Section Executive Committee Vol 2, No. 2 Winter 1993 19
ENAR Meeting Schedule Biopharmaceutical Section Executive Committee Vol 2, No. 2 Winter 1993 18
Minutes of ASA Biopharmaceutical Section Executive Committee, August 9, 1993 Biopharmaceutical Section Executive Committee Vol 2, No. 2 Winter 1993 13
ASA Biopharmaceutical Section Executive Committee & Section Representatives Biopharmaceutical Section Executive Committee Vol 3, No. 1 Summer 1995 19
Corporate Members Biopharmaceutical Section Executive Committee Vol 3, No. 1 Summer 1995 18
Minutes of ASA Biopharmaceutical Section Executive Committee Meeting, August 15, 1994 Biopharmaceutical Section Executive Committee Vol 3, No. 1 Summer 1995 12
Notes of ASA biopharmaceutical Section Executive Committee Meeting, March 28, 1995 Biopharmaceutical Section Executive Committee Vol 3, No. 1 Summer 1995 17
Topics for the Biopharmaceutical Roundtable Luncheon at the 1995 Annual Meeting Biopharmaceutical Section Executive Committee Vol 3, No. 1 Summer 1995 14
ASA Biopharmaceutical Section Executive Committee & Section Representatives Biopharmaceutical Section Executive Committee Vol 4, No. 1 Winter 1996 15
Corporate Members Biopharmaceutical Section Executive Committee Vol 4, No. 1 Winter 1996 9
Minutes of ASA Biopharmaceutical Section Executive Committee Meeting - August 14, 1995 Biopharmaceutical Section Executive Committee Vol 4, No. 1 Winter 1996 5
Minutes of ASA Biopharmaceutical Section Executive Committee Meeting - November 3, 1995 Biopharmaceutical Section Executive Committee Vol 4, No. 1 Winter 1996 6
Mission Statement Biopharmaceutical Section Executive Committee Vol 4, No. 1 Winter 1996 13
Minutes of ASA Biopharmaceutical Section Executive Committee Meeting - March 19, 1996 Biopharmaceutical Section Executive Committee Vol 4, No. 2 Summer 1996 9
Minutes of the ASA Biopharmaceutical Section Executive Committee Meeting - August 6, 1996 Biopharmaceutical Section Executive Committee Vol 5, No. 1 Winter 1997 13
Minutes of the ASA Biopharmaceutical Section Executive Committee Meeting - October 30, 1996 Biopharmaceutical Section Executive Committee Vol 5, No. 1 Winter 1997 17
Biopharmaceutical Section Executive Committee Meeting Minutes, March 25, 1997, Memphis, Tennessee Biopharmaceutical Section Executive Committee Vol 5, No. 2 Summer 1997 8
Minutes of ASA Biopharmaceutical Section Business Meeting, August 12, 1997, Anaheim, California Biopharmaceutical Section Executive Committee Vol 5, No. 3 Fall/Winter 1997 21
Minutes of ASA Biopharmaceutical Section Executive Committee Meeting, August 11, 1997, Anaheim, California Biopharmaceutical Section Executive Committee Vol 5, No. 3 Fall/Winter 1997 17
Congratulations to 1997 ASA Fellows! Biopharmaceutical Section Executive Committee Vol 6, No. 1 Spring 1998 9
Minutes of ASA Biopharmaceutical Section Executive Committee Meeting, October 29, 1997, Bethesda, Maryland Biopharmaceutical Section Executive Committee Vol 6, No. 1 Spring 1998 10
Congratulations 1998 ASA Fellows! Biopharmaceutical Section Executive Committee Vol 6, No. 2 Summer 1998 12
Minutes of ASA Biopharmaceutical Section Executive Meeting, March 31, 1998, Pittsburgh, Pennsylvania Biopharmaceutical Section Executive Committee Vol 6, No. 2 Summer 1998 14
Minutes of ASA Biopharmaceutical Section Business Meeting, August 11, 1998, Dallas, Texas Biopharmaceutical Section Executive Committee Vol 7, No. 1 Spring 1999 20
Minutes of ASA Biopharmaceutical Section Executive Committee Meeting, August 10, 1998, Dallas Texas Biopharmaceutical Section Executive Committee Vol 7, No. 1 Spring 1999 17
FDA/Industry Workshop: Statistical Issues for the New Millennium Biopharmaceutical Section Executive Committee Vol 7, No. 2 Summer 1999 11
The 23rd Annual Midwest Biopharmaceutical Statistics Workshop, May 22-24, 2000 Biopharmaceutical Section Executive Committee Vol 7, No. 3 Fall/Winter 1999 19
Corporate Membership Biopharmaceutical Section Executive Committee Vol 8, No. 1 Spring 2000 14
FDA/Industry Workshop "Statistically Sound Decision Making" Biopharmaceutical Section Executive Committee Vol 8, No. 1 Spring 2000 13
Minutes of the ASA Biopharmaceutical Section Executive Committee Meeting March 20, 2000 Biopharmaceutical Section Executive Committee Vol 8, No. 1 Spring 2000 12
Minutes of the ASA Biopharmaceutical Section Executive Committee Meeting August 15, 2000 Biopharmaceutical Section Executive Committee Vol 8, No. 2 Fall 2000 13
56th Deming Conference Biopharmaceutical Section Executive Committee Vol 8, No. 3 Winter 2000 12
Biopharmaceutical Section Executive Committee, Representatives, and Functions (2000) Biopharmaceutical Section Executive Committee Vol 8, No. 3 Winter 2000 14
Twenty-Fourth Annual Biopharmaceutical Statistics Workshop, May 21-23, 2001 Biopharmaceutical Section Executive Committee Vol 8, No. 3 Winter 2000 13
Annual FDA/Industry Statistics Workshop, September 24-25, 2001 Biopharmaceutical Section Executive Committee Vol 9, No. 1 Summer 2001 14
Corporate Membership Biopharmaceutical Section Executive Committee Vol 9, No. 2 Winter 2001 13
Change in URL for ASA Biopharmaceutical web page Biswas, Nandita Vol 10, No. 1 Spring 2002 4
Letter from the Chairman Bob Davis Vol 5, No. 3 Fall/Winter 1997 23
Book Review: Cross-over Trials in Clinical Research Bolognese, James A. Vol 2, No. 2 Winter 1993 16
Future Biopharmers of America Boyd, Michael N. Vol 2, No. 1 Summer 1993 15
Teaching Statistics for Understanding and Practical Use - Discussion (Statistical Anxiety, Statistical Reasoning, Active Learning, and Intimate Teaching) Bradstreet, Thomas E. Vol 1, No. 2 Summer 1992 12
Introduction to the Book Reviews Bradstreet, Thomas E. Vol 5, No. 1 Winter 1997 1
Review of: Planning Pharmaceutical Clinical Trials - Basic Statistical Principles Bradstreet, Thomas E. Vol 5, No. 1 Winter 1997 5
Letter to Section Members Brooks, Camilla Vol 2, No. 1 Summer 1993 14
Journal Response: Letter to Clinical Pharmacology and Therapeutics Bruce Rodda, Camilla Brooks, Gladys Reynolds Vol 1, No. 3 Fall 1992 12
2000 FDA and Industry Workshop Campbell, Greg Vol 8, No. 1 Spring 2000 12
Annual FDA/Industry Workshop: Statistically Sound Decision Making Campbell, Greg Vol 8, No. 3 Winter 2000 11
The Role of Statistics in Medical Devices - The Contrast with Pharmaceuticals Campbell,Greg Vol 14, No. 1 Winter 2006 1
Deadline for Proposing Invited Paper Sessions Capizzi, Thomas Vol 4, No. 3 Fall 1996 19
Biopharmaceutical Section JSM Scientific/Technical Program Capizzi, Thomas Vol 6, No. 1 Spring 1998 4
Letter from the Chair Capizzi, Thomas Vol 8, No. 1 Spring 2000 11
Letter from the Chair Capizzi, Thomas Vol 8, No. 2 Fall 2000 12
Letter from the Chair Capizzi, Thomas Vol 8, No. 3 Winter 2000 8
Summary of Minutes of ASA Biopharmaceutical Section Transition Meeting, November 1, 2001 Capizzi, Thomas Vol 8, No. 3 Winter 2000 10
Note from the Editors Caplan, Richard Vol 14, No. 2 Summer 2006 1
Opportunities and Challenges for Industry and FDA Cappelleri, Joseph C. Vol 7, No. 1 Spring 1999 1
Biomarkers in Development: Friend or Foe Carroll, Kevin Vol 14, No. 2 Summer 2006 3
Bayesian Adaptive Design Method with Biomarkers Chang, Mark Vol 14, No. 2 Summer 2006 7
Short Courses on Bayesian Clinical Trials at JSM 2005 Chen, Ming-Hui Vol 13, No. 2 Spring 2005 4
1997 JSM Roundtable Luncheon Discussions: Multiple Endpoint Issues in Clinical Trials Chi, George Vol 6, No. 1 Spring 1998 7
Some Comments on "Adaptive Trials and Bayesian Statistics in Drug Development" by Donald A. Berry Chi, George Vol 9, No. 2 Winter 2001 7
Roundtable Discussions: Demands for Flexibility in Clinical Trials Require Innovative Approaches Chi, George Y. H. Vol 7, No. 3 Fall/Winter 1999 6
Individual Bioequivalence: A Problem of Switchability - Discussion Chinchilli, Vern Vol 2, No. 2 Winter 1993 10
Call for Statisticians, Committee for Recommending Statisticians to FDA Advisory Committees (CRSFAC) Chinchilli, Vernon M. Vol 2, No. 2 Winter 1993 15
1997 JSM Roundtable Luncheon Discussions: Interim Analysis and Early Termination in Clinical Trials Choi, Sung C. Vol 6, No. 1 Spring 1998 6
To the Editor, Biopharmaceutical Report Chow, Shein-Chung Vol 2, No. 2 Winter 1993 12
Roundtable Discussion: Issue in Bioequivalence Chow, Shein-Chung Vol 4, No. 1 Winter 1996 12
Safety Analysis: Too Much? Not Enough? and How? Chuang-Stein, Christy Vol 1, No. 3 Fall 1992 1
Cultivating Non-technical Skills of Pharmaceutical Statisticians Chuang-Stein, Christy Vol 13, No. 2 Spring 2005 1
Roundtable Discussion: Testing Does-Response Relationship Based on Ordinal Data Chuang-Stein, Christy Vol 4, No. 1 Winter 1996 8
Workshop on Adverse Events Chuang-Stein, Christy Vol 4, No. 1 Winter 1996 4
Workshop on Adverse Events Chuang-Stein, Christy Vol 4, No. 2 Summer 1996 8
Workshop on the FDA/Industry Partnership Chuang-Stein, Christy Vol 5, No. 2 Summer 1997 11
FDA and Industry: Working Together to Expedite the Development of New Pharmaceutical Products Chuang-Stein, Christy Vol 6, No. 1 Spring 1998 1
Call for Special Contributed Sessions and Invited Posters at the 1999 JSM Chuang-Stein, Christy Vol 6, No. 2 Summer 1998 10
Planning for the '99 ENAR Spring Meeting and the Joint Statistical Meetings Chuang-Stein, Christy Vol 7, No. 1 Spring 1999 16
Pharmaceutical Statisticians in the U.S.: Our Future and Our Direction Chuang-Stein, Christy Vol 7, No. 3 Fall/Winter 1999 1
Letter from the Editor Cnaan, Avital Vol 1, No. 1 Winter 1992 2
Letter from the Editor Cnaan, Avital Vol 1, No. 2 Summer 1992 5
Letter from the Editor Cnaan, Avital Vol 1, No. 3 Fall 1992 11
Letter From the Editor Cnaan, Avital Vol 2, No. 1 Summer 1993 13
Statistical Analysis Plan: Lilly Experiences Costigan, Timothy Vol 10, No. 2 Winter 2002 2
Chairman's Column Davis, Bob Vol 5, No. 1 Winter 1997 12
The History of the Biopharmaceutical Section of the American Statistical Association (ASA), 1966-1988 Davis, Robert L. Vol 13, No. 1 Winter 2005 2
Essential Efficacy Data Analysis - Discussion Davis, Robert L. Vol 2, No. 1 Summer 1993 8
2000 ASA Fellows Davis, Robert L. Vol 8, No. 3 Winter 2000 12
Adaptive Designs in Clinical Trials: Lilly Experience - Discussion Dubey, S. Vol 3, No. 1 Summer 1995 9
Letters: Statistical Analysis Plans Dunning, Andrew J. Vol 11, No. 1 Spring 2003 6
Aspects of the Dissolution Profile Testing Problem Eaton, Morris L. Vol 11, No. 2 Winter 2003 2
Statistical Analysis Plans Eckert, Stephen Vol 10, No. 2 Winter 2002 4
Review of: Multiple Comparisons: Theory and Methods Edwards, Don Vol 5, No. 1 Winter 1997 11
Ethics and Clinical Trials: Some Neglected Issues - Discussion Ellenberg, Susan Vol 1, No. 1 Winter 1992 12
Safety Analysis: Too Much? Not Enough? and How? - Discussion Enas, Gregory G. Vol 1, No. 3 Fall 1992 4
Essential Efficacy Data Analysis Enas, Gregory G. Vol 2, No. 1 Summer 1993 1
Essential Efficacy Data Analysis - Rejoinder Enas, Gregory G. Vol 2, No. 1 Summer 1993 12
FDA/Industry Workshop Enas, Gregory G. Vol 9, No. 1 Summer 2001 13
Book Review: Pharmaceutical Statistics: Practical and Clinical Applications, 2nd Edition Enas, Nathan Vol 4, No. 1 Winter 1996 12
Review of: Health and Numbers: Basic Biostatistical Methods Enas, Nathan Vol 5, No. 1 Winter 1997 10
Adaptive Designs in Clinical Trials: Lilly Experience Faries, Douglas E. , Roy N. Tamura, John S. Andersen Vol 3, No. 1 Summer 1995 1
Adaptive Designs in Clinical Trials: Lilly Experience - Rejoinder Faries, Douglas E. , Roy N. Tamura, John S. Andersen Vol 3, No. 1 Summer 1995 11
Essential Efficacy Data Analysis - Discussion Fisher, Lloyd D. Vol 2, No. 1 Summer 1993 10
Appendix A: The Chronology of the Development of Subsection and Section from 1966 to 1988 Free, Mike Vol 13, No. 1 Winter 2005 20
The History of the Biopharmaceutical Section of the American Statistical Association (ASA), 1966-1988 Free, Mike Vol 13, No. 1 Winter 2005 2
Teaching Statistics for Understanding and Practical Use - Discussion (What Experience in Teaching Shows Us) Free, Spencer M. Vol 1, No. 2 Summer 1992 12
Ethics and Clinical Trials: Some Neglected Issues - Discussion Freedman, Benjamin Vol 1, No. 1 Winter 1992 10
Knowledge Discovery from Databases and Data Mining: New Paradigms for Statistics and Data Analysis? Friedman, Herman P. Vol 8, No. 2 Fall 2000 1
Practical Issues in Linear Model Analyses in Multicenter Clinical Trials Gallo, Paul P. Vol 6, No. 2 Summer 1998 1
A 20,000 Foot Overview of Population Pharmacokinetics and Its Application in Drug Development Ge, Z. Gary Vol 9, No. 1 Summer 2001 1
Rejoinder to "Discussion of 'A 20,000 Foot Overview of Population Pharmacokinetics and Its Application in Drug Development'" Ge, Z. Gary Vol 9, No. 1 Summer 2001 10
Biopharmaceutical Section Web Site Ghosh, Kalyan Vol 7, No. 1 Spring 1999 16
Biopharmaceutical Section Web Site Ghosh, Kalyan Vol 7, No. 2 Summer 1999 10
Note from the Editors Giltinan, David, Demissie Alemayehu, Kevin W. Anderson Vol 13, No. 1 Winter 2005 1
Note from the Editors Giltinan, David, Demissie Alemayehu, Kevin W. Anderson Vol 13, No. 2 Spring 2005 1
Teaching Statistics for Understanding and Practical Use - Discussion (Statistics Education: A Framework and Foci) Gnanadesikan, Ramanathan Vol 1, No. 2 Summer 1992 11
Knowledge Discovery from Databases and Data Mining: New Paradigms for Statistics and Data Analysis? Goldberg, Judith D. Vol 8, No. 2 Fall 2000 1
ASA Fellows Committee Goldsmith, Charles Vol 6, No. 1 Spring 1998 9
ASA Fellows Committee Gould, Larry Vol 6, No. 1 Spring 1998 9
2000 ASA Fellows Gould, Larry Vol 8, No. 3 Winter 2000 12
Software Review: A Taste of S-Plus Gould, Lawrence Gould Vol 1, No. 3 Fall 1992 15
2000 ASA Fellows Gould, Lawrence Gould Vol 8, No. 2 Fall 2000 15
Biostatistics and the Internet: The World Wide Web (WWW) Greenberg, Sally Vol 4, No. 1 Winter 1996 1
Biopharmaceutical Section Starts Electronic Mailing List Greenberg, Sally Vol 5, No. 1 Winter 1997 19
Biopharmaceutical Section Electronic Mailing List Greenberg, Sally Vol 7, No. 2 Summer 1999 10
Minutes of ASA Biopharmaceutical Section Executive Committee Meeting, August 10, 1999, Baltimore, MD Greenberg, Sally Vol 7, No. 3 Fall/Winter 1999 13
Minutes of ASA Biopharmaceutical Section Executive Committee Meeting, March 29, 1999, Atlanta, Georgia Greenberg, Sally Vol 7, No. 3 Fall/Winter 1999 8
The Impact of ICH Guidelines on Protocol Development Grimes, Imogene Vol 7, No. 3 Fall/Winter 1999 7
The History of the Biopharmaceutical Section of the American Statistical Association (ASA), 1966-1988 Guylas, Stephen W. Vol 13, No. 1 Winter 2005 2
Common Challenges Facing Statisticians in Nonclinical Biostatistics - Discussion Hajian, Gerald Vol 7, No. 2 Summer 1999 5
Fourth Annual FDA-Industry Workshop: Statistical Issues for the New Millennium Harkins, Ralph Vol 7, No. 3 Fall/Winter 1999 18
The History of the Biopharmaceutical Section of the American Statistical Association (ASA), 1966-1988 Hearron, Martha S. Vol 13, No. 1 Winter 2005 2
Conference Reports - 1992 Pharmaceutical Manufacturers Association Training Course for New Clinical Statisticians Heft, Samuel Vol 1, No. 2 Summer 1992 17
ENAR 2001 Biopharm Sessions Heft, Samuel Vol 8, No. 3 Winter 2000 11
Best Contributed Paper Award Heft, Sandy Vol 5, No. 3 Fall/Winter 1997 17
2000 FDA and Industry Workshop Heft, Sandy Vol 8, No. 1 Spring 2000 12
ENAR 2001 Heft, Sandy Vol 8, No. 1 Spring 2000 14
Annual FDA/Industry Workshop: Statistically Sound Decision Making Heft, Sandy Vol 8, No. 3 Winter 2000 11
Roundtable Discussion: Strategies for Nominal Alpha Level Adjustments for Multiple Endpoints Helterbrand, Jeffrey D. Vol 4, No. 1 Winter 1996 11
Ethics and Clinical Trials: Some Neglected Issues - Discussion Henderson, I. Craig Vol 1, No. 1 Winter 1992 9
Teaching Statistics for Understanding and Practical Use - Discussion (Concepts in Introductory Courses and Relation to Total Quality Management) Hogg, Robert V. Vol 1, No. 2 Summer 1992 9
Review of: Intuitive Biostatistics Holder, Daniel Vol 5, No. 1 Winter 1997 4
Individual Bioequivalence: A Problem of Switchability - Discussion Holder, Daniel J. Vol 2, No. 2 Winter 1993 9
Discussion of "A 20,000 Foot Overview of Population Pharmacokinetics and Its Application in Drug Development" Hsu, Chyi-Hung , Vol 9, No. 1 Summer 2001 8
Common Challenges Facing Statisticians in Nonclinical Biostatistics - Discussion Huber, Paul B. Vol 7, No. 2 Summer 1999 6
Some Comments on "Adaptive Trials and Bayesian Statistics in Drug Development" by Donald A. Berry Hung, H. M. James Vol 9, No. 2 Winter 2001 7
Roundtable Discussion: Dose Response for Continuous Response Outcome in Clinical Trials Hung, H. M. James Vol 4, No. 1 Winter 1996 11
Letter From the Editors Huster, Bill, Curt Wiltse, Eric Sampson Vol 3, No. 1 Summer 1995 11
Essential Efficacy Data Analysis Huster, William J. Vol 2, No. 1 Summer 1993 1
Essential Efficacy Data Analysis - Rejoinder Huster, William J. Vol 2, No. 1 Summer 1993 12
10th Merck-Temple Conference Iglewicz, Boris Vol 10, No. 1 Spring 2002 4
Book Review: Randomization and Monte Carlo Methods in Biology Iglewicz, Boris Vol 3, No. 1 Summer 1995 17
2006 FDA/Industry Workshop Kaiser, Lee Vol 14, No. 2 Summer 2006 11
Essential Efficacy Data Analysis - Discussion Koch, Gary G. Vol 2, No. 1 Summer 1993 7
Roundtable Discussions: Use of Surrogate Markers in Clinical Trials Kohlberger, Robert C. Vol 7, No. 3 Fall/Winter 1999 6
2006 FDA/Industry Workshop Kotz, Richard Vol 14, No. 2 Summer 2006 11
2004 FDA/Industry Workshop Koury, Ken Vol 13, No. 1 Winter 2005 8
2005 FDA/Industry Workshop, September 14-16, Washington, DC Koury, Ken Vol 13, No. 2 Spring 2005 5
2005 FDA/Industry Workshop Koury, Ken Vol 14, No. 1 Winter 2006 8
Biopharmaceutical Section Activities in Dallas Koury, Ken Vol 6, No. 2 Summer 1998 9
Letter from the Chair Koury, Ken Vol 7, No. 1 Spring 1999 13
Model-Based Drug Development - A New Paradigm for Efficient Drug Development Kowalski, Kenneth G., Wayne Ewy, Matthew M. Hutmacher, Raymond Miller, and Siram Krishnaswami Vol 15, No. 2 Summer 2007 2
FDA/Industry Workshop Lachenbruch, Peter Vol 9, No. 1 Summer 2001 13
Adaptive Designs in Clinical Trials: Lilly Experience - Discussion Lachin, John Vol 3, No. 1 Summer 1995 6
ASA Fellow Nominations Larry Gould Vol 7, No. 1 Spring 1999 14
1994 International Research Conference on Lifetime Data Models in Reliability and Survival Analysis Lee, Mei-Ling Ting Vol 2, No. 2 Winter 1993 17
Appendix D: Letter from Fred Leone to Gary Koch and Marv Zelen dated January 3, 1980 Leone, Fred C. Vol 13, No. 1 Winter 2005 34
Appendix E: Letter from Fred Leone announcing full section status Leone, Fred C. Vol 13, No. 1 Winter 2005 35
Challenges and Opportunities of Biometrics in Post-Approval Drug Development Levenstein, Marcia, Ed Whalen Vol 8, No. 3 Winter 2000 1
Standardized Data Structures and Visualization Tools: A Way to Accelerate the Regulatory Review of the Integrated Summary of Safety of New Drug Applications Levine, Jonathan G. Vol 4, No. 3 Fall 1996 12
Volunteers Needed ENAR/ASA 2003 Lindborg, Stacy Vol 10, No. 1 Spring 2002 4
ENAR and JSM Invited Programs Lindborg, Stacy Vol 10, No. 2 Winter 2002 7
Statistical Analysis Plan: Lilly Experiences Lindborg, Stacy Vol 10, No. 2 Winter 2002 2
Joint Statistics Meeting 2003 Biopharm Final Invited Program Lindborg, Stacy Vol 11, No. 1 Spring 2003 3
Reply to Statistical Analysis Plan in Winter 2002 Biopharmaceutical Report Lindborg, Stacy Vol 11, No. 2 Winter 2003 8
The History of the Biopharmaceutical Section of the American Statistical Association (ASA), 1966-1988 Lindborg, Stacy Vol 13, No. 1 Winter 2005 2
Letter from the Chair Lindborg, Stacy Vol 14, No. 2 Summer 2006 1
Midwest Biopharmaceutical Statistics Workshop Meeting Report, May 21-23, 2001 Lindborg, Stacy Vol 9, No. 2 Winter 2001 14
Review of: Biostatistics - Experimental Design and Statistical Inference Liss, Charles L. Vol 5, No. 1 Winter 1997 3
Individual Bioequivalence: A Problem of Switchability - Discussion Liu, Jen-pei Vol 2, No. 2 Winter 1993 7
To the Editor, Biopharmaceutical Report Liu, Jen-pei Vol 2, No. 2 Winter 1993 12
Discussion of "A 20,000 Foot Overview of Population Pharmacokinetics and Its Application in Drug Development" Ma, Peiming Vol 9, No. 1 Summer 2001 8
1997 JSM Roundtable Luncheon Discussions: In Vitro-In Vivo Relationships for Extended Release Drug Products Mauger, David Vol 6, No. 1 Spring 1998 8
Treasurer's Report for 1996 Meeker, Jeff Vol 5, No. 2 Summer 1997 7
1997 Treasurer’'s Report Meeker, Jeff Vol 6, No. 2 Summer 1998 13
Looking Ahead to 2001 Meeker, Jeff Vol 8, No. 3 Winter 2000 10
Executive Committee Meeting, Monday, March 26, 2001, Charlotte, NC Meeker, Jeff Vol 9, No. 1 Summer 2001 12
Letter from the Chair Meeker, Jeff Vol 9, No. 1 Summer 2001 12
Highlights of Executive Committee Meeting, Tuesday August 7, 2001, Atlanta, GA Meeker, Jeff Vol 9, No. 2 Winter 2001 12
Highlights of Executive Committee Meeting, Tuesday October 23, 2001, Alexandria, VA Meeker, Jeff Vol 9, No. 2 Winter 2001 12
Letter from the Chair Meeker, Jeff Vol 9, No. 2 Winter 2001 11
Vaccine Clinical Trials - A Statistical Primer Mehrotra, Devan V. Vol 12, No. 1 Spring 2004 1
Congratulations 1999 ASA Fellows! Meibohm, Anne Vol 7, No. 3 Fall/Winter 1999 17
Book Review: Design and Analysis of Bioavailability and Bioequivalence Studies Metzler, Carl M. Vol 1, No. 3 Fall 1992 13
Individual Bioequivalence: A Problem of Switchability - Discussion Metzler, Carl M. Vol 2, No. 2 Winter 1993 5
How Blind are Double-Blind Studies When the Product Exhibits a Very Distinct Safety Profile? Meyerson, Laura J. Vol 4, No. 3 Fall 1996 10
Summary of Executive Committee Meeting of ASA Biopharm Section, March 28, 2006 Minkwitz, Margaret Vol 14, No. 2 Summer 2006 12
Aspects of the Dissolution Profile Testing Problem Muirhead, Robb J. Vol 11, No. 2 Winter 2003 2
Biopharmaceutical Section Roundtables, JSM 1998, Dallas, Texas: Dealing with Dropouts in Clinical Studies Myers, William Vol 7, No. 1 Spring 1999 22
Note from the Editors on FDA Draft Guidance on Clinical Trial Data Monitoring Committees Natarajan, Kannan Vol 10, No. 1 Spring 2002 1
Forward (Statistical Analysis Plans) Natarajan, Kannan Vol 10, No. 2 Winter 2002 1
Short Courses on Bayesian Clinical Trials at JSM 2005 Natarajan, Kannan Vol 13, No. 2 Spring 2005 4
Discussion of "A 20,000 Foot Overview of Population Pharmacokinetics and Its Application in Drug Development" Nedelman, Jerry R. Vol 9, No. 1 Summer 2001 8
Letter from the Chairman Neidert, Gary Vol 4, No. 2 Summer 1996 9
Letter from the Chair Neidert, Gary. L. Vol 4, No. 1 Winter 1996 1
FDA/Industry Workshop Nevius Ed / Sanders, Corsee / Rida, Waima Vol 11, No. 1 Spring 2003 4
Call for Invited Sessions in 2004 Nevius, Anna Vol 11, No. 1 Spring 2003 4
Roundtable Discussion: Dose Response for Continuous Response Outcome in Clinical Trials Nevius, S. Edward Vol 4, No. 1 Winter 1996 11
The 24th Annual Midwest Biopharmaceutical Statistics Workshop Nezamis, James Vol 8, No. 2 Fall 2000 15
FDA Corner Ng, Tie-Hua Vol 1, No. 1 Winter 1992 11
A Review of Issues in the Collection and Reporting of Adverse Events Northington, Bob Vol 4, No. 2 Summer 1996 1
Issues and Algorithms in Cost-Effectiveness Inference Obenchain, Robert L. Vol 5, No. 2 Summer 1997 1
Reply to Statistical Analysis Plan in Winter 2002 Biopharmaceutical Report Offen, Walter Vol 11, No. 2 Winter 2003 8
Roundtable Discussion: Strategies for Nominal Alpha Level Adjustments for Multiple Endpoints Offen, Walter Vol 4, No. 1 Winter 1996 11
The History of the Biopharmaceutical Section of the American Statistical Association (ASA), 1966-1988 O'Neill, Robert Vol 13, No. 1 Winter 2005 2
Some Comments on "Adaptive Trials and Bayesian Statistics in Drug Development" by Donald A. Berry O'Neill, Robert Vol 9, No. 2 Winter 2001 7
Short Courses Sponsored by the Biopharmaceutical Section at the August 2002 JSM Meeting in NYC Oppenheimer, Leonard Vol 10, No. 1 Spring 2002 4
Corporate Sponsors Program 2003 Oppenheimer, Leonard Vol 11, No. 1 Spring 2003 5
Letter from the Chair Oppenheimer, Leonard Vol 13, No. 1 Winter 2005 1
Letter from the Chair Oppenheimer, Leonard Vol 14, No. 1 Winter 2006 1
Continuing Education for the 2002 JSM in New York City Oppenheimer, Leonard Vol 9, No. 1 Summer 2001 13
Program Chair Report Oppenheimer, Leonard Vol 9, No. 2 Winter 2001 13
1992 Applied Statistics Conference Peace, Karl E. Vol 1, No. 2 Summer 1992 18
Conference Reports - 1991 Applied Statistics Conference Peace, Karl E. Vol 1, No. 2 Summer 1992 7
Response to "Ethics and Clinical Trials: Some Neglected Issues" Peace, Karl E. Vol 1, No. 2 Summer 1992 6
Note from the Editors Pichotta, Phil Vol 14, No. 2 Summer 2006 1
Note from the Editors Picotta, Phil, Richard Caplan, and Thomas Dobbins Vol 15, No. 2 Summer 2007 1
Biopharmaceutical Section Census Pichotta, Phil Vol 4, No. 2 Summer 1996 9
Report of October 1996 Survey of Biopharmaceutical Section Members Pichotta, Phil Vol 5, No. 3 Fall/Winter 1997 1
Errata in Membership Survey Pichotta, Phil Vol 6, No. 1 Spring 1998 3
Corporate Members Pichotta, Phil Vol 6, No. 2 Summer 1998 11
Biopharmaceutical Section Membership Passes 2000 Pichotta, Phil Vol 7, No. 1 Spring 1999 22
Roundtable Discussion: Use of Serum Drug Concentrations in Design or Analysis of Clinical Trials Pledger, Gordon W. Vol 4, No. 1 Winter 1996 8
2007 FDA/Industry Workshop, September 17-19, Arlington, VA Price, Dionne, and Matilde Sanchez Vol 15, No. 2 Summer 2007 25
A 20,000 Foot Overview of Population Pharmacokinetics and Its Application in Drug Development Raymond , Ralph H. Vol 9, No. 1 Summer 2001 1
Rejoinder to "Discussion of 'A 20,000 Foot Overview of Population Pharmacokinetics and Its Application in Drug Development'" Raymond , Ralph H. Vol 9, No. 1 Summer 2001 10
Journal Response: Letter to Clinical Pharmacology and Therapeutics Reynolds, Gladys, Brooks, Camilla, Bruce Rodda Vol 1, No. 3 Fall 1992 12
FDA/Industry Workshop Rida, Waima / Sanders, Corsee / Nevius Ed Vol 11, No. 1 Spring 2003 4
Safety Analysis: Too Much? Not Enough? and How? - Discussion Roberts, Robin S. Vol 1, No. 3 Fall 1992 6
Journal Response: Letter to Clinical Pharmacology and Therapeutics Rodda Bruce , Camilla Brooks, Gladys Reynolds Vol 1, No. 3 Fall 1992 12
Letter to Members of Biopharmaceutical Section Rodda, Bruce Vol 2, No. 2 Winter 1993 11
ASA Fellows Committee Rodda, Bruce Vol 6, No. 1 Spring 1998 9
Joint Statistics Meetings Best Contributed Paper Awards Roe, Denise J. Vol 8, No. 2 Fall 2000 14
Book Review: Multiple Comparisons, Selection, and Applications in Biometry Rom, Dror M. Vol 2, No. 2 Winter 1993 17
Teaching Statistics for Understanding and Practical Use - Discussion (Statistics at College and High School Level - Some Ideas from the National Council of Teachers of Mathematics) Romberg, Thomas A. Vol 1, No. 2 Summer 1992 7
Ethics and Clinical Trials: Some Neglected Issues - Discussion Royall, Richard M. Vol 1, No. 1 Winter 1992 7
Teaching Statistics for Understanding and Practical Use Ruberg, Stephen J. Vol 1, No. 2 Summer 1992 1
Teaching Statistics for Understanding and Practical Use - Rejoinder Ruberg, Stephen J. Vol 1, No. 2 Summer 1992 14
Discussion of "A 20,000 Foot Overview of Population Pharmacokinetics and Its Application in Drug Development" Sallas, William M. Vol 9, No. 1 Summer 2001 8
Safety Analysis: Too Much? Not Enough? and How? - Discussion Salsburg, David Vol 1, No. 3 Fall 1992 9
Letters: Why Statistical Analysis Plans Should Not be Created Before Unblinding Data Salsburg, David Vol 11, No. 1 Spring 2003 6
Appendix F: Official Request for Biopharm Section Status Sampson, Charles B. Vol 13, No. 1 Winter 2005 36
The History of the Biopharmaceutical Section of the American Statistical Association (ASA), 1966-1988 Sampson, Charles B. Vol 13, No. 1 Winter 2005 2
Letter From the Editors Sampson, Eric, Bill Hustler, Curt Wiltse Vol 3, No. 1 Summer 1995 11
FDA/Industry Workshop Sanders, Corsee / Rida, Waima / Nevius Ed Vol 11, No. 1 Spring 2003 4
Essential Efficacy Data Analysis Sanger, Todd M. Vol 2, No. 1 Summer 1993 1
Essential Efficacy Data Analysis - Rejoinder Sanger, Todd M. Vol 2, No. 1 Summer 1993 12
Teaching Statistics for Understanding and Practical Use - Discussion (Themes for the First Course and Ideas of Pattern, Association, and Model) Schaeffer, Richard L. Vol 1, No. 2 Summer 1992 5
Adverse Events: After 58 Years, Do We Have it Right Yet? Scherer, Joel C. Vol 4, No. 3 Fall 1996 1
Conference Reports - 1992 Pharmaceutical Manufacturers Association Education & Research Institute Training Course in Non-Clinical Statistics Schofield, Tim Vol 1, No. 2 Summer 1992 16
Ethics and Clinical Trials: Some Neglected Issues - Discussion Schor, Stanley Vol 1, No. 1 Winter 1992 7
Report of Biopharmaceutical Section Finance Committee Schultz, John R. Vol 2, No. 1 Summer 1993 15
Stan Schor Receives Career Achievement Award Segreti, Tony Vol 4, No. 3 Fall 1996 19
Individual Bioequivalence: A Problem of Switchability - Discussion Selwyn, Murray R. Vol 2, No. 2 Winter 1993 6
Statistical Analysis Plan: Lilly Experiences Shen, Wei Vol 10, No. 2 Winter 2002 2
Reply to Statistical Analysis Plan in Winter 2002 Biopharmaceutical Report Shen, Wei Vol 11, No. 2 Winter 2003 8
Adaptive Designs in Clinical Trials: Lilly Experience - Discussion Simon, Richard Vol 3, No. 1 Summer 1995 7
Letter from the Chair Small, Bob Vol 10, No. 1 Spring 2002 3
A Last Note From the Chair Small, Bob Vol 10, No. 2 Winter 2002 6
1998 Biopharmaceutical Section/FDA Workshop Small, Bob Vol 6, No. 1 Spring 1998 3
Third Annual FDA-Industry Workshop Small, Bob Vol 7, No. 1 Spring 1999 14
The Use of Restricted Significance Tests in Clinical Trials Small, Robert D. Vol 2, No. 1 Summer 1993 16
A Comment on "Data Safety Monitoring Boards: A Brief Introduction" by Janet Wittes Small, Robert D. Vol 8, No. 1 Spring 2000 8
Letter from the Chair Smith, Nancy D. Vol 11, No. 1 Spring 2003 1
Letter from the Chair Smith, Nancy D. Vol 11, No. 2 Winter 2003 2
A 20,000 Foot Overview of Population Pharmacokinetics and Its Application in Drug Development Smith, Robert A. Vol 9, No. 1 Summer 2001 1
Rejoinder to "Discussion of 'A 20,000 Foot Overview of Population Pharmacokinetics and Its Application in Drug Development'" Smith, Robert A. Vol 9, No. 1 Summer 2001 10
Relaxed Deadline for Student Paper Competition Snapinn, Steve Vol 4, No. 1 Winter 1996 4
Letter from the Chair Snapinn, Steve Vol 7, No. 2 Summer 1999 9
Letter from the Chair Snapinn, Steve Vol 7, No. 3 Fall/Winter 1999 5
A Comment on "Data Safety Monitoring Boards: A Brief Introduction" by Janet Wittes Snapinn, Steve Vol 8, No. 1 Spring 2000 7
2001 ASA Election Candidates Snapinn, Steve Vol 8, No. 2 Fall 2000 14
Software Review - StatXact Version 2 Soper, Keith Vol 1, No. 2 Summer 1992 10
Member Benefits Soper, Keith Vol 11, No. 1 Spring 2003 2
Letter from the Chair Soper, Keith Vol 12, No. 1 Spring 2004 7
Safety Analysis: Too Much? Not Enough? and How? - Discussion Srinivasan, R Vol 1, No. 3 Fall 1992 9
Hints on Preparing a Nomination for ASA Fellow Starbuck, Bob Vol 2, No. 1 Summer 1993 15
Request for Names of ASA Fellow Candidates Starbuck, Bob Vol 3, No. 1 Summer 1995 15
Letter from the Past Chair Starbuck, Bob Vol 3, No. 1 Summer 1995 12
Aspects of the Dissolution Profile Testing Problem Steeno, Gregory S. Vol 11, No. 2 Winter 2003 2
Essential Efficacy Data Analysis - Discussion Stein, Richard A. Vol 2, No. 1 Summer 1993 9
Review of: Seeing Through Statistics Stewart, William H. Vol 5, No. 1 Winter 1997 6
Deming Conference on Applied Statistics Has a Lot to Offer Stock, David Vol 6, No. 2 Summer 1998 11
Standardized Data Structures and Visualization Tools: A Way to Accelerate the Regulatory Review of the Integrated Summary of Safety of New Drug Applications Szarfman, Ana Vol 4, No. 3 Fall 1996 12
1996 JSM Round Table Luncheon Discussions: Adaptive Techniques in Clinical Trials Tamura, Roy Vol 5, No. 3 Fall/Winter 1997 23
Adaptive Designs in Clinical Trials: Lilly Experience Tamura, Roy N, Douglas E. Faries, John S. Andersen Vol 3, No. 1 Summer 1995 1
Adaptive Designs in Clinical Trials: Lilly Experience - Rejoinder Tamura, Roy N, Douglas E. Faries, John S. Andersen Vol 3, No. 1 Summer 1995 11
Biopharmaceutical Work Groups, ASA 1991 Teoh, Nick Vol 1, No. 1 Winter 1992 8
Upcoming Events - Biopharmaceutical Roundtable Luncheons in Boston Teoh, Nick Vol 1, No. 2 Summer 1992 18
Adaptive Designs in Clinical Trials: Lilly Experience - Discussion Teoh, Nick Vol 3, No. 1 Summer 1995 9
Note from the Editors on FDA Draft Guidance on Clinical Trial Data Monitoring Committees Thomas, Neal Vol 10, No. 1 Spring 2002 1
Forward (Statistical Analysis Plans) Thomas, Neal Vol 10, No. 2 Winter 2002 1
Electronic Distribution of Biopharm Report Thomas, Neal Vol 10, No. 2 Winter 2002 7
Roundtable Discussion: Subset Analysis for Phase II/III Studies Ting, Naitee Vol 4, No. 1 Winter 1996 9
1997 JSM Roundtable Luncheon Discussions: Considerations in Designing Dose Response Studies Ting, Naitee Vol 6, No. 1 Spring 1998 6
Describing Risk in Long-Term Clinical Trials Tremmel, Lothar Vol 4, No. 2 Summer 1996 5
Ethics and Clinical Trials: Some Neglected Issues - Discussion Veatch, Robert M. Vol 1, No. 1 Winter 1992 5
Best Paper Awards for 1995 Weng, C. S. Wayne Vol 4, No. 1 Winter 1996 4
Best Paper Awards for 1995 JSM Weng, C. S. Wayne Vol 4, No. 2 Summer 1996 12
Reply to Statistical Analysis Plan in Winter 2002 Biopharmaceutical Report Westfall, Peter H. Vol 11, No. 2 Winter 2003 8
Challenges and Opportunities of Biometrics in Post-Approval Drug Development Whalen, Ed, Marcia Levenstein Vol 8, No. 3 Winter 2000 1
1997 JSM Roundtable Luncheon Discussions: Active Control Equivalence Trials Whitmore, James B. Vol 6, No. 1 Spring 1998 5
Corporate Sponsorship Program Wiens, Brian L. Vol 13, No. 1 Winter 2005 11
Highlights of the Biopharmaceutical Section Executive Committee Meeting, Atlanta, Georgia, March 12, 2007 Wiens, Brian L. Vol 15, No. 2 Summer 2007 23
Letter from the Chair Wiens, Brian L. Vol 15, No. 2 Summer 2007 2
Midwest Biopharmaceutical Statistics Workshop Update Wiens, Brian L. Vol 14, No. 2 Summer 2006 2
Review of: Clinical Epidemiology: The Essentials (Third Edition) Wiens, Brian L. Vol 5, No. 1 Winter 1997 9
Review of: All That Glitters Is Not Gold - What Clinicians Need to Know About Clinical Trials Wilson, Michael G. Vol 5, No. 1 Winter 1997 8
Editor's Note Wiltse, Curt Vol 4, No. 2 Summer 1996 1
Editor's Note Wiltse, Curt Vol 4, No. 3 Fall 1996 1
Letter From the Editors Wiltse, Curt, Bill Hustler, Eric Sampson Vol 3, No. 1 Summer 1995 11
Adverse Events: After 58 Years, Do We Have it Right Yet? Wiltse, Curtis G. Vol 4, No. 3 Fall 1996 1
Safety Analysis: Too Much? Not Enough? and How? - Discussion Wittes, Janet Vol 1, No. 3 Fall 1992 10
A Statistical Perspective on Adverse Event Reporting in Clinical Trials Wittes, Janet Vol 4, No. 3 Fall 1996 5
1996 JSM Round Table Luncheon Discussions: Adverse Event Reporting Wittes, Janet Vol 5, No. 3 Fall/Winter 1997 22
Data Safety Monitoring Boards: A Brief Introduction Wittes, Janet Vol 8, No. 1 Spring 2000 1
Response Wittes, Janet Vol 8, No. 1 Spring 2000 10
Biopharmaceutical Section Roundtable Discussion for Joint Statistical Meetings - Orlando 1995 Yuh, Lianng Vol 4, No. 1 Winter 1996 8
Biopharmaceutical Section Student Paper Awards Yuh, Lianng Vol 4, No. 3 Fall 1996 19
Opportunities and Challenges for Industry and FDA Yuh, Lianng Vol 7, No. 1 Spring 1999 1
Ethics and Clinical Trials: Some Neglected Issues Zelen, Marvin Vol 1, No. 1 Winter 1992 1
Ethics and Clinical Trials: Some Neglected Issues - Rejoinder Zelen, Marvin Vol 1, No. 1 Winter 1992 13
Response to "Ethics and Clinical Trials: Some Neglected Issues" Zelen, Marvin Vol 1, No. 2 Summer 1992 6
Best Student Paper Award Winners Zhang, Ji Vol 6, No. 2 Summer 1998 12
Conference Report - 1992 ENAR Spring Meeting in Cincinnati   Vol 1, No. 2 Summer 1992 15
Upcoming Events - American Statistical Association Joint Meetings - Boston, August 1992 Vol 1, No. 2 Summer 1992 18
Appendix B: List of Presidents and Secretaries and ASA Board Representatives of BPSS/Biopharm   Vol 13, No. 1 Winter 2005 32
Appendix C: History of the MBSW Vol 13, No. 1 Winter 2005 33
Appendix G: Scope of the Biopharm and Biometrics Charters   Vol 13, No. 1 Winter 2005 51
Appendix H: Listing of ASA Fellows with Biopharm/BPSS Roots Vol 13, No. 1 Winter 2005 52
Biopharmaceutical Section Members Elected ASA Fellows   Vol 15, No 2 Summer 2007 22

 




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