ƒ of IV = 1 by definition, but… [Off Topic]
Actually it's not about a bioequivalence study or comparative BA study. It's about two intravenous formulations that one of them has longer half-life hence larger exposure. So I'm just bothered by which one of bioavailability fits this situation by definition, absolute or relative.
BTW, the guideline I refer to is FDA's "Bioavailability Studies Submitted in NDAs or INDs — General Considerations", page 3.
Edit: Please follow the Forum’s Policy. Guidance linked. [Helmut]
BTW, the guideline I refer to is FDA's "Bioavailability Studies Submitted in NDAs or INDs — General Considerations", page 3.
Edit: Please follow the Forum’s Policy. Guidance linked. [Helmut]
Complete thread:
- A boring question about bioavailability? Darborn 2024-08-01 09:05 [Off Topic]
- ƒ of IV = 1 by definition, but… Helmut 2024-08-01 12:05
- ƒ of IV = 1 by definition, but…Darborn 2024-08-01 12:36
- IV: Different half-lives? Helmut 2024-08-01 13:43
- IV: Different half-lives? Darborn 2024-08-02 02:39
- IV: Liposome encapsuled drug, pegylated biologic? Helmut 2024-08-02 07:52
- IV: Liposome encapsuled drug, pegylated biologic? Darborn 2024-08-06 05:15
- IV: Liposome encapsuled drug, pegylated biologic? Helmut 2024-08-02 07:52
- IV: Different half-lives? Darborn 2024-08-02 02:39
- IV: Different half-lives? Helmut 2024-08-01 13:43
- ƒ of IV = 1 by definition, but…Darborn 2024-08-01 12:36
- ƒ of IV = 1 by definition, but… Helmut 2024-08-01 12:05