ORALLY INHALED AND NASAL DRUG PRODUCTS SUBCOMMITTEE OF

THE ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

April 26, 2000

Slides

 Introduction and Objectives, Eric Sheinin, Ph.D. .ppt .html

Chemistry, Manufacturing and Controls:

Content Uniformity

Alternative Statistical Approaches, Walter W. Hauck, Ph.D., Thomas Jefferson University .pdf

Bioavailability (BA) and Bioequivalence (BE)

Current FDA BA/BE Background and Issues, Wallace P. Adams, Ph. D., FDA .ppt .html

 

In Vitro BA and BE Testing

Profile Analysis of Cascade Impactor Data: Proposed FDA Approach, Yi Tsong, Ph.D. .ppt .html

Profile Analysis of Cascade Impactor Data: An Alternative View, Andrew R. Clark, Ph.D. .ppt .html

DPIs: In Vitro Tests for Performance and Comparability, David Ganderton, Ph.D., Vectura Limited .ppt .html

Data related to BE testing of Nasal Sprays, and Comments on the BE Studies of Nasal Sprays for Systeic Action, Abdul Zahir, Ph.D., Clay-Park Labs, Inc. .pdf

Uniqueness of Lingual Spray Delivery, Harry Dugger, Ph.D., Flemington Pharmaceutical .ppt .html

Ligual Solution Sprays .doc .pdf

 AAPS Inhalation Technology Focus Group(ITFG)/ International Pharmaceutical Aerosol Consortium (IPAC) Collaboration Technical Teams:

Overview of the ITFG/IPAC Collaboration, R. Harris Cummings, Ph.D., Magellan Laboratories .ppt .html

Presentation on the Work of the BA/BE Team , Stephen J. Farr, Ph.D., Aradigm Corporation .ppt .html

Presentation on the Work of the Specifications Team (Dose Content Uniformity/ Particle Size Distribution), Bo Olsson, Ph.D., AstraZeneca .ppt .html

Presentation on the Work of the Tests and Methods Team, Carole Evans, Ph.D., Magellan Laboratories .ppt .html

Presentation on the Work of the Supplier Quality Control Team, Gordon Hansen, Boehringer Ingelheim .ppt .html

Presentation on the Work of the Leachables and Extractables Team, Kaushik J. Dave, .Ph., M.R.P.S., Ph.D., Schering-Plough Research Institute .ppt .html

Concluding Presentation on ITFG/IPAC Collaboration, Cynthia Flynn, Ph.D., Aventis .ppt .html

CMC Issues, Kenneth B. Neugebauer, Solvay Fluorides, Inc. .pdf

Growth Effects of Nasal Steroids in Children and Differences among the steroid preparations, Eric J. Schenkel, M.D., Valley Clinical Research Center .pdf

In Vivo BA and BE

Clinical Studies for Local Delivery of Nasal Aerosols and Sprays, Izabela Roman, M.D., Ph.D. .ppt .html

PK and PD Studies for Systemic Exposure of Locally Acting Drugs

Pharmacokinetic Studies for Oral Inhalation Aerosols and Nasal Sprays - Current FDA Practices, V. Ramana S. Uppoor, Ph.D. .ppt .html

PK and PD Studies for Systemic Exposure of Locally Acting Drugs: Industry View, Lester I. Harrison, Ph.D. .ppt .html

Pharmacokinetic and Pharmacodynamic Studies for System Exposure of Locally Acting Drugs: Academic View, Hartmut Derendorf, Ph.D. .ppt

Questions for the Advisory Committee Meeting On Orally Inhaled and Nasal drug Products Subcommittee for Pharmaceutical Sciences, Sean Alan F.X. Reade, MA, Boehringer Ingelheim Roxane Laboratories .doc .pdf

Statement of the ITFG/IPAC Collaboration on Chemistry, Manufacturing, and Controls and In Vitro and In Vivo Bioavailability/Bioequivalence Issues in Draft Guidance Documents for Orally Inhaled and Nasal Drug Products .doc .pdf

Questions, Virginia Z. Fojas, Roxane Laboratories, Inc. .doc .pdf

Questions and Comments, Jennifer Daly, Byron Chemical Company, Inc. .pdf

Dose Content uniformity: Current Practices for NDAs, Gurag Poochikian PhD .pdf

Clinical Studies to Assess Inhaled Corticosteroid Bioequivalence, Richard C. Ahrens, MD, University of Iowa .pdf