suchit_bhavsar ★ India, 2021-08-27 07:02 (1167 d 19:22 ago) Posting: # 22548 Views: 2,789 |
|
Dear All, Hello to every one. As per latest published draft guideline "Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA", under heading Data deletion because of vomiting, one sentence is there like The concentration data for the subject who vomited should be reported Hence it is required to report concentration data of subject who had vomited for the USFDA studies Valuable suggestions required Regards, Suchit Bhavsar Edit: Guidance linked. [Helmut] |
Helmut ★★★ Vienna, Austria, 2021-08-27 12:31 (1167 d 13:53 ago) @ suchit_bhavsar Posting: # 22549 Views: 2,356 |
|
Hi Suchit, ❝ As per latest published draft guideline "Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA" […] one sentence is there like The concentration data for the subject who vomited should be reported ❝ ❝ Hence it is required to report concentration data of subject who had vomited for the USFDA studies Correct. ❝ Valuable suggestions required Suggestions about what? Simply follow the guidance. BTW, in my CRO we always analyzed all samples.* Justification: Although subjects who vomited (IR \(\small{\leq 2\times\widetilde{t_\textrm{max,R}}}\) and MR \(\small{\leq\tau}\)) were excluded from the comparison according to the protocol, their profile was informative. It’s always good to learn something. It turned out that – surprisingly more often than not – the effect was a minor one.
— 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 |