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Generic Bioequivalence
Since 1996, Novotech has been involved in bioequivalence testing and introduction of over 100 new generic formulations to the Australian and New Zealand markets. Starting from 2006 this service has been extended to bioequivalence testing for sponsors in overseas markets. In particular for US and EU based sponsors, Australia and New Zealand represent a very significant cost saving opportunity for conduct of bioequivalence studies with no compromise in quality. Novotech’s unique “distributed network” approach for managing bioequivalence studies means highly cost effective outcomes in relation to clinical beds and drug assay laboratories are attained. In addition, Australia’s streamlined regulatory system means a typical project involving a single-dose, linear kinetic active ingredient study can be conceived, conducted and reported in as little as 3 - 4 months.
Supported by the market leading WinNonlin® platform for pharmacokinetic modelling and statistical output, these factors add up to a compelling case for considering Australia for your next generic BE study. |
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