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Generics, chemisimilars and biosimilars: is clinical testing fit for purpose?
The effectiveness and safety of generic drugs are backed by sound physicochemical control and regulatory bioequivalence acceptance criteria. Statistical testing of bioequivalence, comparing the pharmacokinetic profiles of the test and reference products, was made possible by modern drug assays. When...
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| Hovedforfatter: | |
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| Format: | Artigo |
| Sprog: | Inglês |
| Udgivet: |
Blackwell Science Inc
2013
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| Fag: | |
| Online adgang: | https://ncbi.nlm.nih.gov/pmc/articles/PMC3555041/ https://ncbi.nlm.nih.gov/pubmed/22574725 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/j.1365-2125.2012.04323.x |
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