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
Respiratory Drug Delivery
Europe 2009
May 19-22 2009
Corinthia Hotel, Lisbon, Portugal
Presentations Related to Inhaled Generic Pharmaceutical Products at RDD Europe 2009
- "Effects of Device Design on Patient Compliance: Comparing the Same Drug in Different
Devices"
Henry Chrystyn, University of Huddersfield
- "Quality By Design For Analytical Methods Intended For Use With Orally Inhaled And
Nasal Drug Products (OINDPs)"
Andrew Rignall, AstraZeneca
- "Rationalized Approach to Chemistry, Manufacturing & Control (CMC) Requirements
for Orally Inhaled and Nasal Drug Products (OINDPs) Based on Risk Management"
Stephen Horhota, Boehringer Ingelheim
- "In Vitro and In Vivo Dose Linearity of Beclometasone Dipropionate (BDP) in a pMDI
BDP plus Formoterol Fixed Combination"
Sara Collarini, Chiesi Farmaceutici
- "Size Matters: a Method Comparison for Aqueous Drug Suspensions for Nebulization"
Maren Kuhli, Christian Albrecht University
- "TwinCaps: Developing an in-vitro equivalent DPI"
Pedro Jorge Mendes, Hovione Farmaciencia
- "Cascade Impaction Components Ratio as a Quick Tool for Evaluation of Analyst and
Product Performance"
Bela Elkin, PPD
- "Performance Verification of Copley Inhaler Testing Data Analysis Software"
Lynn Krebs, PPD
- "In-vitro In-vivo Correlations for a Short Acting Bronchodilator using Artificial
Neural Networks"
Marcel de Matas, University of Bradford
- "Visualizing the Effect of Cascade Impactor Operating Temperature on the Size and
Evaporation Rate of Nebulized Droplets"
Wenchi Hsu, University of Maryland, Baltimore
- High Dose Respiratory Medicines: Pharmacopeia Methodologies for Determining Aerodynamic
Mass Distributions"
Wai Hang William Wong, University of Sydney
- Principles of Quality by Design Applied to the Selection of Labels for Inhalation
Drug Products"
Diane Paskiet, West Analytical Services
Inhalation Aerosol Technology Workshop
June 15-18, 2009
University of Maryland School of Pharmacy, Baltimore
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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