Darborn ☆ Taiwan, 2024-08-01 11:05 (132 d 20:32 ago) Posting: # 24118 Views: 2,009 |
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According to the guideline, "absolute bioavailabiliy" is defined as bioavailability of formulation A compared to formulation B (which is a intravenous formulation), while "relative bioavailability" is defined when formulation B is a non-intravenous formulation. So here is the question, if two formulation are both intravenous formulation, should I call is absolute BA study or relative BA study? Edit: Please follow the Forum’s Policy. [Helmut] |
Helmut ★★★ Vienna, Austria, 2024-08-01 14:05 (132 d 17:32 ago) @ Darborn Posting: # 24119 Views: 1,707 |
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Hi Darbon, ❝ According to the guideline, … ❝ […] if two formulation are both intravenous formulation, should I call is absolute BA study or relative BA study? 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.
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Darborn ☆ Taiwan, 2024-08-01 14:36 (132 d 17:01 ago) @ Helmut Posting: # 24120 Views: 1,710 |
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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] |
Helmut ★★★ Vienna, Austria, 2024-08-01 15:43 (132 d 15:54 ago) @ Darborn Posting: # 24122 Views: 1,677 |
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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. ❝ the guideline I refer to is FDA's "Bioavailability Studies Submitted in NDAs or INDs — General Considerations", page 3. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Darborn ☆ Taiwan, 2024-08-02 04:39 (132 d 02:58 ago) @ Helmut Posting: # 24123 Views: 1,621 |
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Hi Helmut, Forgive me for impoliteness, thinking this just a random talk about this question. It do has a longer half-life, and I'm just trying to find the right terminology (so I put this under "off topic" category . Thank you for patient explanation Darborn |
Helmut ★★★ Vienna, Austria, 2024-08-02 09:52 (131 d 21:45 ago) @ Darborn Posting: # 24125 Views: 1,638 |
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Hi Darborn, ❝ It do has a longer half-life, …
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Darborn ☆ Taiwan, 2024-08-06 07:15 (128 d 00:22 ago) @ Helmut Posting: # 24141 Views: 1,431 |
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Hi Helmut, It is actual a FDC which the elimination of one drug is interupted by another. So the overall exposure is increased to reduce the administration times per day. |