Generic Pharmaceuticals Focus Group Bulletin Board
Purpose and Description
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
AAPS Workshop on Challenges and Opportunities in Establishing
Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products
October 1-2, 2009
Sheraton Inner Harbor Hotel, Baltimore, MD
2009 AAPS Annual Meeting and Exposition
November 8-12, 2009
Los Angeles Convention Center, Los Angeles, California
Presentations
How to Define Reference Standards for Biologics – Scientific and Regulatory Considerations Roundtable
Held during the 2009 AAPS National Biotechnology Conference
Publications
Bioequivalence approaches for highly variable drugs and drug products. Pharmaceutical Research, Vol. 25, No. 1, 237-241, 2008.
Highly variable drugs: Observations from bioequivalence data submitted to the FDA for new generic drug applications. The AAPS Journal, Vol. 10, No 1, 148-156, 2008.
Evaluation of a scaling approach for the bioequivalence of highly variable drugs. The AAPS Journal, Vol. 10, No. 3, 450-454, 2008.
Regulatory Conditions for the Determination of Bioequivalence of Highly Variable Drugs. Journal of Pharmacy & Pharmaceutical Sciences, Vol. 12, No. 1, 138-149, 2009.
Other Websites of Interest to GPFG Members
PQRI Workshop on Demonstrating
Bioequivalence of Locally Acting Orally Inhaled Drug Products
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
JOIN THE GENERIC PHARMACEUTICALS FOCUS GROUP
To join the Generic Pharmaceuticals Focus Group, click
here.
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