Bioequivalence and Bioavailability Forum • IV: Different half-lives?

IV: Different half-lives? [Off Topic]

posted by Helmut – Vienna, Austria, 2024-08-01 15:43 (305 d 11:57 ago) – Posting: # 24122
Views: 2,891

Hi Daborn,

it would be nice to say “hello” or similar in the future.

❝ It's about two intravenous formulations that one of them has longer half-life hence larger exposure.

Half-life (based on \(\small{k_\text{el}}\) – or \(\small{CL}\), if you belong to the other church) is a property of the drug. Can you give more details please?

❝ the guideline I refer to is FDA's "Bioavailability Studies Submitted in NDAs or INDs — General Considerations", page 3.

Nothing stated about parenterals in the entire guidance. If you are concerned about the terminology only, use the generic term Comparative Bioavailability Study. Fits to any.

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