E-drug: therapeutic equivalence lists
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WHO's recommendations on how to assess therapeutic equivalence
between generic products have been published in WHO Tech Rep Ser 863
in 1996. WHO lists examples from Germany, Canada and USA in an annex,
giving lists of which drugs need bioavailability or other in vivo studies, and which
ones can 'prove' their equivalence with dissolution or other in
vitro tests.
Could E-drug members send me details of other countries' policies on
this matter, especially any published Regulations or lists of
products that require in vivo or in vitro studies.
Ian Roberts
Special Advisor to the Minister of Health
South Africa
Email: irobmoh@global.co.za
Fax: +27-21-451575
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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