E-DRUG: Bioavailability studies for all generics?

E-drug: Bioavailability studies for all generics?
-----------------------------------------------------------------

Another debate in South Africa about the revised SA Drug Legislation
concentrates on the question whether generic drug companies should
present bio-availability studies for the registration of ALL generic
products.

Currently, bioavailability studies is only required for registering a
limited list of sensitive products, and most generics are registered
using dissolution tests etc. Bio-availability tests are complicated
and expensive.

Which countries require that ALL generics be tested using
bio-availability studies, and which countries are happy with the much
simpler and cheaper dissolution tests?

Anyone who knows a good expert or an answer on this issue,
please send an email direct to me at 73377.3055@compuserve.com

Thank you very much,

Wilbert Bannenberg
Wilbert Bannenberg, SADAP Coordinator
Hallmark 938, P/Bag X 828, Pretoria 0001, South Africa
Tel work +27-12-3120374/5 Fax +27-12-3244525 Cellphone +27-82-5756249
Email 73377.3055@compuserve.com or bannew@hltrsa.pwv.gov.za
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.