Generic Drug Product Development

Generic Drug Product Development

4.11 - 1251 ratings - Source



The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.The increasing complexity of drug therapy regimens has increased the risk of fooda€“drug interactions, and it is important that healthcare professionals are aware of the mechanisms behind the interactions and also realize the advantages andanbsp;...


Title:Generic Drug Product Development
Author: Isadore Kanfer, Leon Shargel
Publisher:CRC Press - 2007-11-15
ISBN-13:

You must register with us as either a Registered User before you can Download this Book. You'll be greeted by a simple sign-up page.

Once you have finished the sign-up process, you will be redirected to your download Book page.

How it works:
  • 1. Register a free 1 month Trial Account.
  • 2. Download as many books as you like (Personal use)
  • 3. Cancel the membership at any time if not satisfied.


Click button below to register and download Ebook
Privacy Policy | Contact | DMCA