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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
Note from the Editors   Vol 15, No. 2 Summer 2007 1
Letter from the Chair Brian Wiens Vol 15, No. 2 Summer 2007 2
Biopharmaceutical Section Members Elected ASA Fellows Keith Soper Vol 15, No. 2 Summer 2007 22
Highlights of the Biopharmaceutical Section Executive Committee Meeting, Atlanta, Georgia, March 12 2007 Brian Wiens Vol 15, No. 2 Summer 2007 23
Biopharmaceutical Section Program for JSM 2007 Amit Bhattacharyya Vol 15, No. 2 Summer 2007 24
2007 FDA/Industry Workshop, September 17-19, Arlington, VA Dionne Price and Matilde Sanchez Vol 15, No. 2 Summer 2007 25
Let's hear from you   Vol 15, No. 2 Summer 2007 26
Note from the Editor   Vol 15, No. 1 Winter 2007 1
Letters from the Chair Brian Wiens Vol 15, No. 1 Winter 2007 1
Biopharmaceutical Section Executive Committee Minutes   Vol 15, No. 1 Winter 2007 12
2006 Treasurer's Report Mani Lakshminarayanan Vol 15, No. 1 Winter 2007 13
Corporate Sponsorship Program Jim Colainne Vol 15, No. 1 Winter 2007 14
New Distance Training Program Alex Dmitrienko Vol 15, No. 1 Winter 2007 15
Biopharmaceutical Section Student Paper Award 2007 : Submission Guidelines Aparna Raychaudhuri Vol 15, No. 1 Winter 2007 15
The 30th Annual Midwest Biopharmaceutical Statistics Workshop : Preliminary Program   Vol 15, No. 1 Winter 2007 16
Workshop in Bayesian Biostatistics Amy Herring Vol 15, No. 1 Winter 2007 19
Note from the Editors Richard Caplan, Philip Pichotta Vol 14, No. 2 Summer 2006 1
Letter from the Chair Stacy Lindborg Vol 14, No. 2 Summer 2006 1
Midwest Biopharmaceutical Statistics Workshop Update Brian L. Wiens Vol 14, No. 2 Summer 2006 2
Biomarkers in Development: Friend or Foe Kevin Carroll Vol 14, No. 2 Summer 2006 3
Bayesian Adaptive Design Method with Biomarkers Mark Chang Vol 14, No. 2 Summer 2006 7
2006 FDA/Industry Workshop Richard Kotz, Lee Kaiser Vol 14, No. 2 Summer 2006 11
Summary of Executive Committee Meeting of ASA Biopharm Section, March 28, 2006 Margaret Minkwitz Vol 14, No. 2 Summer 2006 12
JSM 2006 Luncheon Roundtables Amit Bhattacharyya Vol 14, No. 2 Summer 2006 12
Letter from the Chair Leonard Oppenheimer Vol 14, No. 1 Winter 2006 1
The Role of Statistics in Medical Devices - The Contrast with Pharmaceuticals Greg Campbell Vol 14, No. 1 Winter 2006 1
2005 FDA/Industry Workshop Ken Koury Vol 14, No. 1 Winter 2006 8
The 29th Annual Midwest Biopharmaceutical Statistics Workshop Biopharmaceutical Section Executive Committee Vol 14, No. 1 Winter 2006 10
Note from the Editors Demissie Alemayehu, David Giltinan, Kevin W. Anderson Vol 13, No. 2 Spring 2005 1
Cultivating Non-technical Skills of Pharmaceutical Statisticians Christy Chuang-Stein Vol 13, No. 2 Spring 2005 1
Short Courses on Bayesian Clinical Trials at JSM 2005 Kannan Natarajan, Ming-Hui Chen Vol 13, No. 2 Spring 2005 4
2005 FDA/Industry Workshop, September 14-16, Washington, DC Ken Koury Vol 13, No. 2 Spring 2005 5
Note from the Editors Demissie Alemayehu, David Giltinan, Kevin W. Anderson Vol 13, No. 1 Winter 2005 1
Letter from the Chair Leonard Oppenheimer Vol 13, No. 1 Winter 2005 1
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
2004 FDA/Industry Workshop Ken Koury Vol 13, No. 1 Winter 2005 8
Minutes of the ASA Biopharm Executive Committee Meeting at JSM 2004 at Toronto, Canada Amit Bhattacharyya Vol 13, No. 1 Winter 2005 9
Corporate Sponsorship Program Brian L. Wiens Vol 13, No. 1 Winter 2005 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
Vaccine Clinical Trials - A Statistical Primer Devan V. Mehrotra Vol 12, No. 1 Spring 2004 1
Letter from the Chair Keith Soper Vol 12, No. 1 Spring 2004 7
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
Electronic Distribution of Biopharmaceutical Report Biopharmaceutical Section Executive Committee Vol 11, No. 2 Winter 2003 1
2003 Biopharmaceutical Section Corporate Sponsors Biopharmaceutical Section Executive Committee Vol 11, No. 2 Winter 2003 1
Letter from the Chair Nancy D. Smith Vol 11, No. 2 Winter 2003 2
Aspects of the Dissolution Profile Testing Problem Morris L. Eaton, Robb J. Muirhead, Gregory S. Steeno Vol 11, No. 2 Winter 2003 2
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
Minutes - Biopharmaceutical Section Executive Meeting, ENAR at Tampa, Florida, 1-April 2003 Biopharmaceutical Section Executive Committee Vol 11, No. 2 Winter 2003 9
Electronic Distribution of Biopharmaceutical Report Biopharmaceutical Section Executive Committee Vol 11, No. 1 Spring 2003 1
Letter from the Chair Nancy D. Smith Vol 11, No. 1 Spring 2003 1
Member Benefits Keith Soper Vol 11, No. 1 Spring 2003 2
Joint Statistics Meeting 2003 Biopharm Final Invited Program Stacy Lindborg Vol 11, No. 1 Spring 2003 3
Call for Invited Sessions in 2004 Anna Nevius Vol 11, No. 1 Spring 2003 4
FDA/Industry Workshop Corsee Sanders, Wasima Rida, Ed Nevius Vol 11, No. 1 Spring 2003 4
Corporate Sponsors Program 2003 Leonard Oppenheimer Vol 11, No. 1 Spring 2003 5
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
Forward (Statistical Analysis Plans) Kevin W. Anderson, Kannan Natarajan, Neal Thomas Vol 10, No. 2 Winter 2002 1
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
A Last Note From the Chair Bob Small Vol 10, No. 2 Winter 2002 6
Electronic Distribution of Biopharm Report Neal Thomas Vol 10, No. 2 Winter 2002 7
ENAR and JSM Invited Programs Stacy Lindborg Vol 10, No. 2 Winter 2002 7
The 26th Annual Midwest Biopharmaceutical Statistics Workshop, May 19-21, 2003 Biopharmaceutical Section Executive Committee Vol 10, No. 2 Winter 2002 8
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
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
Letter from the Chair Bob Small Vol 10, No. 1 Spring 2002 3
Change in URL for ASA Biopharmaceutical web page Nandita Biswas Vol 10, No. 1 Spring 2002 4
Volunteers Needed ENAR/ASA 2003 Stacy David Vol 10, No. 1 Spring 2002 4
10th Merck-Temple Conference Boris Iglewicz Vol 10, No. 1 Spring 2002 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
Continuing Education Program Seeks Student Monitors for Continuing Education Courses at JSM Biopharmaceutical Section Executive Committee Vol 10, No. 1 Spring 2002 5
Adaptive Trials and Bayesian Statistics in Drug Development Donald A. Berry Vol 9, No. 2 Winter 2001 1
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
Rejoinder to discussants George Chi, H. M. James Hung, Robert O'Neill Donald A. Berry Vol 9, No. 2 Winter 2001 10
Letter from the Chair Jeff Meeker Vol 9, No. 2 Winter 2001 11
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
Program Chair Report Leonard Oppenheimer Vol 9, No. 2 Winter 2001 13
Corporate Membership Biopharmaceutical Section Executive Committee Vol 9, No. 2 Winter 2001 13
Midwest Biopharmaceutical Statistics Workshop Meeting Report, May 21-23, 2001 Stacy David Vol 9, No. 2 Winter 2001 14
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
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
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
Letter from the Chair Jeff Meeker Vol 9, No. 1 Summer 2001 12
Executive Committee Meeting, Monday, March 26, 2001, Charlotte, NC Jeff Meeker Vol 9, No. 1 Summer 2001 12
FDA/Industry Workshop Peter Lachenbruch, Gregory Enas Vol 9, No. 1 Summer 2001 13
Continuing Education for the 2002 JSM in New York City Leonard Oppenheimer Vol 9, No. 1 Summer 2001 13
Annual FDA/Industry Statistics Workshop, September 24-25, 2001 Biopharmaceutical Section Executive Committee Vol 9, No. 1 Summer 2001 14
Editor's Note Demissie Alemayehu Vol 8, No. 3 Winter 2000 1
Challenges and Opportunities of Biometrics in Post-Approval Drug Development Ed Whalen, Marcia Levenstein Vol 8, No. 3 Winter 2000 1
Letter from the Chair Tom Capizzi Vol 8, No. 3 Winter 2000 8
Looking Ahead to 2001 Jeff Meeker Vol 8, No. 3 Winter 2000 10
Summary of Minutes of ASA Biopharmaceutical Section Transition Meeting, November 1, 2001 Tom Capizzi Vol 8, No. 3 Winter 2000 10
ENAR 2001 Biopharm Sessions Samuel M. Heft Vol 8, No. 3 Winter 2000 11
Annual FDA/Industry Workshop: Statistically Sound Decision Making Gregory Campbell, Sandy Heft Vol 8, No. 3 Winter 2000 11
2000 ASA Fellows Robert L. Davis, Larry Gould Vol 8, No. 3 Winter 2000 12
56th Deming Conference Biopharmaceutical Section Executive Committee Vol 8, No. 3 Winter 2000 12
Twenty-Fourth Annual Biopharmaceutical Statistics Workshop, May 21-23, 2001 Biopharmaceutical Section Executive Committee Vol 8, No. 3 Winter 2000 13
Biopharmaceutical Section Executive Committee, Representatives, and Functions (2000) Biopharmaceutical Section Executive Committee Vol 8, No. 3 Winter 2000 14
Editor's Note Demissie Alemayehu Vol 8, No. 2 Fall 2000 1
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 Tom Capizzi Vol 8, No. 2 Fall 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
2001 ASA Election Candidates Steve Snapinn Vol 8, No. 2 Fall 2000 14
Joint Statistics Meetings Best Contributed Paper Awards Denise J. Roe Vol 8, No. 2 Fall 2000 14
2000 ASA Fellows A. Lawrence Gould Vol 8, No. 2 Fall 2000 15
The 24th Annual Midwest Biopharmaceutical Statistics Workshop James Nezamis Vol 8, No. 2 Fall 2000 15
Data Safety Monitoring Boards: A Brief Introduction Janet Wittes Vol 8, No. 1 Spring 2000 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
Response Janet Wittes Vol 8, No. 1 Spring 2000 10
Letter from the Chair Thomas Capizzi Vol 8, No. 1 Spring 2000 11
Minutes of the ASA Biopharmaceutical Section Executive Committee Meeting March 20, 2000 Biopharmaceutical Section Executive Committee Vol 8, No. 1 Spring 2000 12
2000 FDA and Industry Workshop Greg Campbell, Sandy Heft Vol 8, No. 1 Spring 2000 12
FDA/Industry Workshop "Statistically Sound Decision Making" Biopharmaceutical Section Executive Committee Vol 8, No. 1 Spring 2000 13
ENAR 2001 Sandy Heft Vol 8, No. 1 Spring 2000 14
Corporate Membership Biopharmaceutical Section Executive Committee Vol 8, No. 1 Spring 2000 14
Pharmaceutical Statisticians in the U.S.: Our Future and Our Direction Christy Chuang-Stein Vol 7, No. 3 Fall/Winter 1999 1
Letter from the Chair Steven Snapinn Vol 7, No. 3 Fall/Winter 1999 5
Roundtable Discussions: Use of Surrogate Markers in Clinical Trials Robert C. Kohberger Vol 7, No. 3 Fall/Winter 1999 6
Roundtable Discussions: Demands for Flexibility in Clinical Trials Require Innovative Approaches George Y. H. Chi Vol 7, No. 3 Fall/Winter 1999 6
The Impact of ICH Guidelines on Protocol Development Imogene Grimes Vol 7, No. 3 Fall/Winter 1999 7
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, August 10, 1999, Baltimore, MD Sally Greenberg Vol 7, No. 3 Fall/Winter 1999 13
Congratulations 1999 ASA Fellows! Anne Meibohm Vol 7, No. 3 Fall/Winter 1999 17
Fourth Annual FDA-Industry Workshop: Statistical Issues for the New Millennium Ralph Harkins Vol 7, No. 3 Fall/Winter 1999 18
The 23rd Annual Midwest Biopharmaceutical Statistics Workshop, May 22-24, 2000 Biopharmaceutical Section Executive Committee Vol 7, No. 3 Fall/Winter 1999 19
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
Letter from the Chair Steven Snapinn Vol 7, No. 2 Summer 1999 9
Biopharmaceutical Section Electronic Mailing List Sally Greenberg Vol 7, No. 2 Summer 1999 10
Biopharmaceutical Section Web Site Kalyan Ghosh Vol 7, No. 2 Summer 1999 10
FDA/Industry Workshop: Statistical Issues for the New Millennium Biopharmaceutical Section Executive Committee Vol 7, No. 2 Summer 1999 11
Opportunities and Challenges for Industry and FDA Joseph C. Cappelleri, Lianng Yuh Vol 7, No. 1 Spring 1999 1
Letter from the Chair Kenneth J. Koury Vol 7, No. 1 Spring 1999 13
Third Annual FDA-Industry Workshop Bob Small Vol 7, No. 1 Spring 1999 14
ASA Fellow Nominations Larry Gould Vol 7, No. 1 Spring 1999 14
Planning for the '99 ENAR Spring Meeting and the Joint Statistical Meetings Christy Chuang-Stein Vol 7, No. 1 Spring 1999 16
Biopharmaceutical Section Web Site Kalyan Ghosh Vol 7, No. 1 Spring 1999 16
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 Business Meeting, August 11, 1998, Dallas, Texas Biopharmaceutical Section Executive Committee Vol 7, No. 1 Spring 1999 20
Biopharmaceutical Section Roundtables, JSM 1998, Dallas, Texas: Dealing with Dropouts in Clinical Studies William Myers Vol 7, No. 1 Spring 1999 22
Biopharmaceutical Section Membership Passes 2000 Phil Pichotta Vol 7, No. 1 Spring 1999 22
Biopharmaceutical Section Roundtables, JSM 1998, Dallas, Texas: Statistical Analysis in Outcomes and Pharmacoeconomic Studies Christopher M. Barker Vol 7, No. 1 Spring 1999 23
Practical Issues in Linear Model Analyses in Multicenter Clinical Trials Paul P. Gallo Vol 6, No. 2 Summer 1998 1
Biopharmaceutical Section Activities in Dallas Kenneth J. Koury Vol 6, No. 2 Summer 1998 9
Call for Special Contributed Sessions and Invited Posters at the 1999 JSM Christy Chuang-Stein Vol 6, No. 2 Summer 1998 10
Deming Conference on Applied Statistics Has a Lot to Offer David Stock Vol 6, No. 2 Summer 1998 11
Corporate Members Phil Pichotta Vol 6, No. 2 Summer 1998 11
Congratulations 1998 ASA Fellows! Biopharmaceutical Section Executive Committee Vol 6, No. 2 Summer 1998 12
Best Student Paper Award Winners Ji Zhang Vol 6, No. 2 Summer 1998 12
1997 Treasurer’'s Report Jeff Meeker Vol 6, No. 2 Summer 1998 13
Minutes of ASA Biopharmaceutical Section Executive Meeting, March 31, 1998, Pittsburgh, Pennsylvania Biopharmaceutical Section Executive Committee Vol 6, No. 2 Summer 1998 14
FDA and Industry: Working Together to Expedite the Development of New Pharmaceutical Products Christy Chuang-Stein Vol 6, No. 1 Spring 1998 1
1998 Biopharmaceutical Section/FDA Workshop Bob Small Vol 6, No. 1 Spring 1998 3
Errata in Membership Survey Phil Pichotta Vol 6, No. 1 Spring 1998 3
Biopharmaceutical Section JSM Scientific/Technical Program Tom Capizzi Vol 6, No. 1 Spring 1998 4
1997 JSM Roundtable Luncheon Discussions: Active Control Equivalence Trials James B. Whitmore Vol 6, No. 1 Spring 1998 5
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: Considerations in Designing Dose Response Studies Naitee Ting 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 JSM Roundtable Luncheon Discussions: In Vitro-In Vivo Relationships for Extended Release Drug Products David Mauger Vol 6, No. 1 Spring 1998 8
Congratulations to 1997 ASA Fellows! Biopharmaceutical Section Executive Committee Vol 6, No. 1 Spring 1998 9
ASA Fellows Committee Larry Gould, Charles Goldsmith, Bruce Rodda 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
Report of October 1996 Survey of Biopharmaceutical Section Members Philip J. Pichotta Vol 5, No. 3 Fall/Winter 1997 1
Best Contributed Paper Award Sandy Heft Vol 5, No. 3 Fall/Winter 1997 17
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 Business Meeting, August 12, 1997, Anaheim, California Biopharmaceutical Section Executive Committee Vol 5, No. 3 Fall/Winter 1997 21
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
1996 JSM Round Table Luncheon Discussions: Adaptive Techniques in Clinical Trials Roy N. Tamura Vol 5, No. 3 Fall/Winter 1997 23
Letter from the Chairman Bob Davis Vol 5, No. 3 Fall/Winter 1997 23
Issues and Algorithms in Cost-Effectiveness Inference Robert L. Obenchain Vol 5, No. 2 Summer 1997 1
Treasurer's Report for 1996 Jeff Meeker Vol 5, No. 2 Summer 1997 7
Biopharmaceutical Section Executive Committee Meeting Minutes, March 25, 1997, Memphis, Tennessee Biopharmaceutical Section Executive Committee Vol 5, No. 2 Summer 1997 8
Workshop on the FDA/Industry Partnership Christy Chuang-Stein Vol 5, No. 2 Summer 1997 11
Introduction to the Book Reviews Thomas E. Bradstreet Vol 5, No. 1 Winter 1997 1
Review of: Biostatistics - Experimental Design and Statistical Inference Charles L. Liss Vol 5, No. 1 Winter 1997 3
Review of: Intuitive Biostatistics Daniel Holder Vol 5, No. 1 Winter 1997 4
Review of: Planning Pharmaceutical Clinical Trials - Basic Statistical Principles Thomas E. Bradstreet Vol 5, No. 1 Winter 1997 5
Review of: Seeing Through Statistics William H. Stewart Vol 5, No. 1 Winter 1997 6
Review of: Practical Statistics for Medical Research Michael Ames Vol 5, No. 1 Winter 1997 7
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: 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: Multiple Comparisons: Theory and Methods Don Edwards Vol 5, No. 1 Winter 1997 11
Chairman's Column Bob Davis Vol 5, No. 1 Winter 1997 12
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 Starts Electronic Mailing List Sally Greenberg Vol 5, No. 1 Winter 1997 19
Editor's Note Curtis Wiltse Vol 4, No. 3 Fall 1996 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
A Statistical Perspective on Adverse Event Reporting in Clinical Trials Janet Wittes Vol 4, No. 3 Fall 1996 5
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
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
Deadline for Proposing Invited Paper Sessions Tom Capizzi Vol 4, No. 3 Fall 1996 19
Stan Schor Receives Career Achievement Award Tony Segreti Vol 4, No. 3 Fall 1996 19
Biopharmaceutical Section Student Paper Awards Lianng Yuh Vol 4, No. 3 Fall 1996 19
Editor's Note Curtis Wiltse Vol 4, No. 2 Summer 1996 1
A Review of Issues in the Collection and Reporting of Adverse Events Bob Northington Vol 4, No. 2 Summer 1996 1
Describing Risk in Long-Term Clinical Trials Lothar Tremmel Vol 4, No. 2 Summer 1996 5
Workshop on Adverse Events Christy Chuang-Stein Vol 4, No. 2 Summer 1996 8
Letter from the Chairman Gary Neidert Vol 4, No. 2 Summer 1996 9
Biopharmaceutical Section Census Phil Pichotta Vol 4, No. 2 Summer 1996 9
Minutes of ASA Biopharmaceutical Section Executive Committee Meeting - March 19, 1996 Biopharmaceutical Section Executive Committee Vol 4, No. 2 Summer 1996 9
Best Paper Awards for 1995 JSM C. S. Wayne Weng Vol 4, No. 2 Summer 1996 12
Letter from the Chair Gary. L. Neidert Vol 4, No. 1 Winter 1996 1
Biostatistics and the Internet: The World Wide Web (WWW) Sally Greenberg Vol 4, No. 1 Winter 1996 1
Workshop on Adverse Events Christy Chuang-Stein Vol 4, No. 1 Winter 1996 4
Relaxed Deadline for Student Paper Competition Steven Snapinn Vol 4, No. 1 Winter 1996 4
Best Paper Awards for 1995 C. S. Wayne Weng Vol 4, No. 1 Winter 1996 4
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
Biopharmaceutical Section Roundtable Discussion for Joint Statistical Meetings - Orlando 1995 Lianng Yuh Vol 4, No. 1 Winter 1996 8
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 Discussion: Subset Analysis for Phase II/III Studies Naitee Ting Vol 4, No. 1 Winter 1996 9
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: 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
Corporate Members Biopharmaceutical Section Executive Committee Vol 4, No. 1 Winter 1996 9
Book Review: Pharmaceutical Statistics: Practical and Clinical Applications, 2nd Edition Nathan Enas Vol 4, No. 1 Winter 1996 12
Mission Statement Biopharmaceutical Section Executive Committee Vol 4, No. 1 Winter 1996 13
ASA Biopharmaceutical Section Executive Committee & Section Representatives Biopharmaceutical Section Executive Committee Vol 4, No. 1 Winter 1996 15
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
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
Minutes of ASA Biopharmaceutical Section Executive Committee Meeting, August 15, 1994 Biopharmaceutical Section Executive Committee Vol 3, No. 1 Summer 1995 12
Topics for the Biopharmaceutical Roundtable Luncheon at the 1995 Annual Meeting Biopharmaceutical Section Executive Committee Vol 3, No. 1 Summer 1995 14
Request for Names of ASA Fellow Candidates Bob Starbuck Vol 3, No. 1 Summer 1995 15
Notes of ASA biopharmaceutical Section Executive Committee Meeting, March 28, 1995 Biopharmaceutical Section Executive Committee Vol 3, No. 1 Summer 1995 17
Book Review: Randomization and Monte Carlo Methods in Biology Boris Iglewicz Vol 3, No. 1 Summer 1995 17
Corporate Members Biopharmaceutical Section Executive Committee Vol 3, No. 1 Summer 1995 18
ASA Biopharmaceutical Section Executive Committee & Section Representatives Biopharmaceutical Section Executive Committee Vol 3, No. 1 Summer 1995 19
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
Letter to Members of Biopharmaceutical Section Bruce Rodda Vol 2, No. 2 Winter 1993 11
To the Editor, Biopharmaceutical Report Shein-Chung Chow, Jen-pei Liu Vol 2, No. 2 Winter 1993 12
Minutes of ASA Biopharmaceutical Section Executive Committee, August 9, 1993 Biopharmaceutical Section Executive Committee Vol 2, No. 2 Winter 1993 13
Call for Statisticians, Committee for Recommending Statisticians to FDA Advisory Committees (CRSFAC) Vernon M. Chinchilli Vol 2, No. 2 Winter 1993 15
Book Review: Cross-over Trials in Clinical Research James A. Bolognese Vol 2, No. 2 Winter 1993 16
Book Review: Multiple Comparisons, Selection, and Applications in Biometry Dror M. Rom Vol 2, No. 2 Winter 1993 17
1994 International Research Conference on Lifetime Data Models in Reliability and Survival Analysis Mei-Ling Ting Lee Vol 2, No. 2 Winter 1993 17
ENAR Meeting Schedule Biopharmaceutical Section Executive Committee Vol 2, No. 2 Winter 1993 18
ASA Biopharmaceutical Section Executive Committee & Section Representatives - 1994 Biopharmaceutical Section Executive Committee Vol 2, No. 2 Winter 1993 19
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
Minutes of the August 10, 1992, ASA Biopharmaceutical Section Business Meeting Biopharmaceutical Section Executive Committee Vol 2, No. 1 Summer 1993 13
Letter From the Editor Avital Cnaan Vol 2, No. 1 Summer 1993 13
Letter to Section Members Camilla Brooks Vol 2, No. 1 Summer 1993 14
Report of Biopharmaceutical Section Finance Committee John R. Schultz Vol 2, No. 1 Summer 1993 15
Hints on Preparing a Nomination for ASA Fellow Robert R. Starbuck Vol 2, No. 1 Summer 1993 15
Future Biopharmers of America Michael N. Boyd Vol 2, No. 1 Summer 1993 15
The Use of Restricted Significance Tests in Clinical Trials Robert D. Small Vol 2, No. 1 Summer 1993 16
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 - 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
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