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In Vitro Dissolution of Generic Immediate-Release Solid Oral Dosage Forms Containing BCS Class I Drugs: Comparative Assessment of Metronidazole, Zidovudine, and Amoxicillin Versus Relevant Comparator Pharmaceutical Products in South Africa and India

Biowaivers are recommended for immediate-release solid oral dosage forms using dissolution testing as a surrogate for in vivo bioequivalence studies. Several guidance are currently available (the World Health Organization (WHO), the US FDA, and the EMEA) where the conditions are described. In this s...

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Hlavní autoři: Reddy, Nallagundla H. S., Patnala, Srinivas, Löbenberg, Raimar, Kanfer, Isadore
Médium: Artigo
Jazyk:Inglês
Vydáno: Springer US 2014
Témata:
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC4179660/
https://ncbi.nlm.nih.gov/pubmed/24848760
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12249-014-0135-6
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