Bioequivalence Requirements in Various Global Jurisdictions
Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biow...
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| Language: | English |
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Cham :
Springer International Publishing : Imprint: Springer,
2017.
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| Edition: | 1st ed. 2017. |
| Series: | AAPS Advances in the Pharmaceutical Sciences Series,
28 |
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| Online Access: | https://doi.org/10.1007/978-3-319-68078-1 |