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  Generic Pharmaceuticals Focus Group
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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  Leadership

Chair
Mei-Ling Chen, Ph.D
Office of Pharmaceutical Science, Food and Drug Administration
Potomac, MD United States



Chair-Elect
Saji K. Thomas
Par Pharmaceuticals
Scarsdale, NY United States



Past Chair
Pei Fan Bai, Ph.D.
FDA
Silver Spring, MD




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