Australia’s = EMA’s MR guideline [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2017-02-04 19:25 (2925 d 11:19 ago) – Posting: # 17013
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Hi Muthu Raj,

❝ The European Union guidelines adopted in Australia

❝ Primary PK Parameter: AUC0-t and Cmax

❝ Secondary PK Parameter: Tmax


Here you err. Om Prakash is dealing with a modified-release product. Hence, the respective guideline should be observed (as mentioned by Dan above).

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