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

 




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