Food and Drug Administration

Pharmaceutical Science Advisory Committee

October 21, 2002

Slides

Introductory Remarks, Helen Winkle, FDA (HTM) (PPT)

Presentation by the Pharmacology-Toxicology Subcommittee, Frank Sistare, FDA (HTM) (PPT)

Presentation by the Noncllinical Studies Subcommittee: Update of Activities, Dr. Doull (HTM) (PPT)

Presentation by the Pharmacology-Toxicology Subcommittee, Robert Osterberg, FDA (HTM) (PPT)

Process Analytical Technologies Sub-Committee Report, Dr. Tom Layloff, PhD, FDA (HTM) (PPT)

Risk Based CMC Review An Update, Dr. Yuan-yuan Chiu, PhD, FDA (HTM) (PPT)

Update on Risk-Based CMC Review, Dr. Vilayat Sayeed, PhD, FDA (HTM) (PPT)

Blend Uniformity: Update, Dr. Ajaz Hussain, PhD, FDA (HTM) (PPT)

Regulatory Issues Related to Crystal Habits - Polymorphism, Gary Buehler, R.Ph, FDA (HTM) (PPT)

Scientific Considerations of Polymorphism in ANDAs, Dr. Lawrence Yu, PhD, FDA (HTM) (PPT)

Discussion Questions of Polymorphism in ANDAs, Ken Morris, Purdue University (HTM) (PPT)

Consideration of Polymorphism in Therapeutic Equivalence, Dr. Leslie Benet, PhD, U. of California (HTM) (PPT)