E-drug: Bioavailability studies for all generics?
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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
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