ƒ of IV = 1 by definition, but… [Off Topic]

posted by Helmut Homepage – Vienna, Austria, 2024-08-01 14:05 (344 d 08:32 ago) – Posting: # 24119
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Hi Darbon,

❝ According to the guideline, …

Which guideline are you referring to?

❝ […] if two formulation are both intravenous formulation, should I call is absolute BA study or relative BA study? :confused:

The EMA’s guideline (page 23):

Bioequivalence studies are generally not required if the test product is to be administered as an aqueous intravenous solution containing the same active substance as the currently approved product. However, if any excipients interact with the drug substance (e.g. complex formation), or otherwise affect the disposition of the drug substance, a bioequivalence study is required unless both products contain the same excipients in very similar quantity and it can be adequately justified that any difference in quantity does not affect the pharmacokinetics of the active substance.

If the conditions for waiving are not applicable, call it a comparative BA study.

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