FDA Critical Path Initiatives: Opportunities for Generic Drug Development
Journal Title: The AAPS Journal - Year 2008, Vol 10, Issue 1
Abstract
FDA’s critical path initiative documents have focused on the challenges involved in the development of new drugs. Some of the focus areas identified apply equally to the production of generic drugs. However, there are scientific challenges unique to the development of generic drugs as well. In May 2007, FDA released a document “Critical Path Opportunities for Generic Drugs” that identified some of the specific challenges in the development of generic drugs. The key steps in generic product development are usually characterization of the reference product, design of a pharmaceutically equivalent and bioequivalent product, design of a consistent manufacturing process and conduct of the pivotal bioequivalence study. There are several areas of opportunity where scientific progress could accelerate the development and approval of generic products and expand the range of products for which generic versions are available, while maintaining high standards for quality, safety, and efficacy. These areas include the use of quality by design to develop bioequivalent products, more efficient bioequivalence methods for systemically acting drugs (expansion of BCS waivers, highly variable drugs), and development of new bioequivalence methods for locally acting drugs.
Authors and Affiliations
Robert A. Lionberger
Keywords
Related Articles
- EP ID EP681538
- DOI 10.1208/s12248-008-9010-2
- Views 103
- Downloads 0
Issues related to targeted delivery of proteins and peptides
While modern genomic and proteomic technology enables rapid screening of novel proteins and peptides as potential drug candidates, design of delivery systems for these biologics remains challenging especially to achieve...
Multidrug Resistance Proteins (MRPs) and Cancer Therapy
The ATP-binding cassette (ABC) transporters are members of a protein superfamily that are known to translocate various substrates across membranes, including metabolic products, lipids and sterols, and xenobiotic drugs....
Pharmacokinetics of Orally Inhaled Drug Products
The presentations at the Orlando Inhalation Conference on pharmacokinetic (PK) studies indicated that PK is the most sensitive methodology for detecting formulation differences of oral inhaled drug products (OIDPs) that...
Hidalgo, I. J., Raub, T. J., and Borchardt, R. T.: Characterization of the Human Colon Carcinoma Cell Line (Caco-2) as a Model System for Intestinal Epithelial Permeability, Gastroenterology, 96, 736–749, 1989—The Backstory
This manuscript was written with the knowledge and input of Ismael J. Hidalgo and Thomas J. Raub, who were coauthors of the 1989 Gastroenterology paper describing for the first time Caco-2 cell monolayers as a cell cultu...
The Use of Modeling Tools to Drive Efficient Oral Product Design
Modeling and simulation of drug dissolution and oral absorption has been increasingly used over the last decade to understand drug behavior in vivo based on the physicochemical properties of Active Pharmaceutical Ingredi...