E-drug: Time needed to provide bioequivalence studies (cont'd)
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Dear Jamie,
In South Africa bio-equivalence studies can be done in a few
months. Once the generic company has accepted our quote we can
perform the study straight away (4-10 weeks). Laboratory analysis
takes 4-8 weeks, while data mangement also takes some time
(4-10 weeks).
These time frames vary from product to product. The generic
company can then submit their dossier for registration.
Bio-equivalence is very costly in South Africa.
Kind regards,
Esthi Beukes
Pharmacist
Clindev -clinical research organisation
South Africa
e-mail: biodev@mweb.co.za
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