Reports

CDDS PBPK Conference, "Physiologically-Based Pharmacokinetics (PBPK) in Drug Development and Regulatory Science": Final Report, published in AAPS PharmSci.
2004

Research Documents

Simulation in Drug Development: Good Practices

Collaboration on Drug Development Improvement

Public Policy Documents

Comments on Exposure-Response Guidance, June 2002 (PDF)

Comments on FDA Proposed Labeling Regimen, June 2001 (PDF)

Comments on Draft Guidance on Statistical Principles for Clinical Trials, July 1997:

• Letter to FDA with General Comments
  
• Draft Guidance with Comments

Comments on Draft Guidance on Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products, May 1997:

• Letter to FDA with General Comments
• General Comments and Recommendations

Testimony for the Hearing Record

Latest News

Improving Drug Development Using Patient Adherence Data in Clinical Trials, May 6-7, 2008.
Brochure (PDF)
Registration site

Advanced NONMEM workshop – March 17–19, 2008 at Mission Bay Conference Center, San Francisco, CA.
More information >

UCSF-CDDS to launch The American Course on Drug Development and Regulatory Science- September 2007
More information >

CDDS – Pharmacometric Services is available to drug researchers
More >

Howard Lee, MD, PhD, named Director of CDDS
More >

Lewis B. Sheiner Memorial. Symposium held at CDDS in December 2006
More >