Generic Pharmaceuticals Focus Group Bulletin Board
In response to an increased growth in consumer desire and interest in generic products, the need for
scientific foundations in the development and manufacture of generic
pharmaceutics has been recognized. It is estimated that Americans regularly
spend billions of dollars annually on generic products, and the availability of
generic products for health benefits has become mainstream.
During the last ten years, the generic pharmaceutical industry has
undergone significant change. The early founders of the industry might find it
hard to believe that more and more generic firms are increasingly looking like
brand companies.
Several questions would emerge and need to be addressed by scientists in the area of
pharmaceutical technology and regulatory affairs:
- Where does the technology come from?
- What are the new technology platforms?
- What is the suitable generic drug candidate?
- Will ANDA applicants have to file another ANDA for the OTC product?
- Will there be an Rx as well as OTC market for these products?
It's unlikely that any of these
questions or issues can be answered with any degree of certainty.
The mission of the Generic Pharmaceuticals Focus Group (GPFG) is to continue advancing pharmaceutical science and technology as applied to the generic products in a multidisciplinary approach. Any AAPS member with interest in generic pharmaceuticals is welcome to join GPFG and actively participate in the activities of the Focus Group.
Upcoming Events
2008 AAPS National Biotechnology Conference
June 22-25, 2008
Metro Toronto Convention Centre, Toronto, Canada
Quality-by-Design, June 23
Biosimilars and Follow-on Proteins
- Current Progress and Considerations for Registration of Follow-On Protein Products, June 23
- Update and Impact of Legislation and Regulations for Biosimilars June 25
2008 AAPS Annual Meeting and Exposition
November 17-20, 2008
Georgia World Congress Center, Atlanta, GA
General
- Need for New Product Development Model in Generic Pharmaceutical Industry:
Science vs. First to File Opportunities (Symposium), Nov. 18
Quality-by-Design
- Establish Out-of-Trend Limits: Based on Quality-by-Design, Nov. 17
- Particle Size Analysis and Specification of Pharmaceutical Powders, Nov. 17
- Critical versus Non-Critical Classification in the Absence of a Biorelevant Method, Nov. 17
- PATability of Excipients, Nov. 17
- Challenges and Opportunities in the Implementation of PAT and Real-Time Release in the Pharmaceutical Industry, Nov. 19
- Drug Substance and Drug Product Interface: a Critical Step toward Quality-by-Design for Pharmaceutical Products, Nov. 19
- Challenges in Developing Inhalation and Nasal Products: Linking to Quality-by-Design, Nov. 19
- Analytical Method Development Based on QbD Principles, Nov. 20
- A Risk-based, Systems and Integrated Approach for Quality-by-Design Implementation in Pharmaceutical Industry, Nov. 20
- Quality-by-Design: Defining Clinically Relevant Design Goals, Nov. 20
- APQ open forum: Application of principles of QbD to analytical methodologies, specification and control strategies, Nov. 20
Special/Complex/Biotech Products
- Biosimilars/Follow-on Proteins: the Latest Regulatory Position in the US and EU, Nov. 18
- Generic Biologics – What You Always Wanted to Know, but Were Afraid to Ask. Nov. 20
Orally and Nasally Inhaled Products
- Challenges in Developing Inhalation and Nasal Products: Linking to Quality-by-Design, Nov. 19
- In-Vitro Bioequivalence Testing for Nasal Spray Products: from Today to Tomorrow, Nov. 19
- Biomarkers of Local Drug Delivery from Pulmonary Drug Products, Nov. 20
Publications
Pharmaceutical Research, Volume 25, Number 1, Page 237-241 / January, 2008
To view this paper, you must be logged into AAPS Pharmaceutica.
Bioequivalence Approaches for Highly Variable Drugs and Drug Products
GPFG Minutes
Other Websites of Interest to GPFG Members
BIO: Follow-on Biotechnology Products
FDA: Regulatory and Scientific Issues Related to Developing
Follow-On Protein Products
Genentech: Follow-on Biologics
GPhA: Generic Biopharmaceutics
Statement of Lester M. Crawford, FDA: "The Law of Biologic Medicine"
U.S. Food and Drug Administration Guidance Documents
Podium Presentations Related to Inhaled Generic Pharmaceutical Products
Respiratory Drug Delivery Europe 2007
April 17-20 2007, Novotel Paris Tour Eiffel, Paris, France
- “Pharmacodynamic Testing of Inhaled Products – Economically Feasible Trials for Generic Inhalers”
Richard Ahrens, Ph.D., Professor, University of Iowa, Iowa City, Iowa, USA
- “Crucial Biopharmaceutical Issues facing Macromolecular Candidates for Inhalation”
Rita Vanbever, Ph.D., Universite Catholique de Louvain, Brussels, Belgium
- “Quality by Design Approaches for Orally Inhaled and Nasal Drug Products in the USA”
Prasad Peri, Ph.D., Food and Drug Administration, Silver Springs, Maryland, USA
- “Application of Quality by Design to Inhalation Products”
Nola Bowles, B.Sc., 3M Drug Delivery Systems, Loughborough, United Kingdom
- “Streamlining Inhaler Development using Pugh Concept Selection”
Kevin Stapleton, Ph.D., Gilead Sciences, Seattle, Washington, USA
- “The Regulatory Demands of Clinical Testing Protocols for Powder Inhalers in the USA”
Badrul A. Chowdhury, M.D. Ph.D., Food and Drug Administration, Silver Springs, Maryland, USA
- “Contrasting Regulatory Equivalence Demands between the EU and the USA - History, Law, Markets and Future Needs”
John Hall, M.B. Ch.B., Quintiles and John Hall Consulting Limited, Guildford, United Kingdom
- “Demonstrating Bioequivalence of Dry Powder Inhalers: Are Regulators Ready and Where are the Major Obstructions?”
Caroline Vanneste, Ph.D., Health Canada, Ottawa, Canada
- “Gaining Approval to Market Therapeutically Equivalent Inhalers in the EU: An Industry Perspective”
Gaetano Brambilla, B.Pharm., Chiesi Farmaceutici, Parma, Italy
- “Regulatory Approval of Inhalation Products in Japan”
Richard T. Malley, B.Sc., GlaxoSmithKline, Ware, United Kingdom
- “Can we Move toward Harmonized Requirements for Bioequivalence?”
Peter R. Byron, Ph.D., Virginia Commonwealth University, Richmond, Virginia, USA
JOIN THE GENERIC PHARMACEUTICALS FOCUS GROUP
To join the Generic Pharmaceuticals Focus Group, click here.
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