ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

July 19, 2001

Slides

REPORTS FROM SUBCOMMITTEES

Orally Inhaled and Nasal Drug Products Subcommittee

The June 1999 Draft BA/BE Guidance for Nasal Aerosols and Nasal Sprays, Vincent H L Lee PhD, FDA   ppt   htm

Difficulties in showing a dose-response with locally-acting nasal sprays and aerosols for allergic rhinitis, Badrul A Chowdhury MD PhD, FDA   ppt   htm

Clinical Study Options for locally acting nasal suspension products, Robert J Meyer MD, FDA   ppt   htm

The June 1999 Draft BA/BE Guidance for Nasal Aerosols and Nasal Sprays:  Recommendations of the OINDP Subcommittee, Wallace P Adams, PhD, FDA   ppt   htm

NonClinical Studies Subcommittee

Working Group Progress, William D Kerns, DVM, MS, DACVP   ppt   htm

Gordon Holt PhD   ppt   htm

Nonclinical Studies Subcommittee Next Steps, Helen Winkle, FDA   ppt   htm

Chemistry, Manufacturing, and Controls

An Introduction and Overview of Risk-Based CMC Review, Yuan-yuan Chiu PhD, FDA   ppt   htm

Risk-Based CMC Review AAPS Workshop Report: Drug Substance Issues, Eric P Duffy   ppt   htm

Update on Risk-Based CMC Review, Vilayat A Sayeed PhD, FDA   ppt   htm

Risk-Based CMC Microbiology Review, David Hussong PhD   ppt   htm

Risk-Based CMC Review, GMP Breakout Sessions Summary, Pat Alcock Lefler   ppt   htm

Next Steps Risk-Based CMC Review, Yuan-yuan Chiu PhD, FDA   ppt   htm

Questions on Risk-Based CMC Review, Yuan-yuan Chiu PhD, FDA   ppt   htm

Open Public Hearing

Bioequivalence Studies and Other Recommendations for Orally Inhaled and Nasal Drug Products: Work of the ITFG/IPAC-RS Collaboration, David Radspinner PhD, Carole Evans PhD, James Blanchard PhD and Joe Sequeira PhD   ppt   htm

Optimal Applications of At-line Process Controls on Pharmaceutical Production

Optimal Applications of "In-Line" or "At-Line" Manufacturing Controls in Pharmaceutical Production, Ajaz S Hussain PhD, FDA   ppt  htm

Continuous Quality Verification (CQV), G K Raju PhD, Massachusetts Institute of Technology   ppt   htm

Microbiology

New Microbiological Technologies, David Hussong PhD   ppt   htm

Microbial Limit Testing Technology Overview, Bryan S Riley PhD   ppt   htm

Validation Issues, Kenneth H Muhvich PhD   ppt   htm

Rapid Microbiology Methods: Industry Concerns, Jean Moldenhauer, Vectech Pharmaceutical Consultants Inc   ppt  htm