Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
Visual inspection of fits (estimation of λ-z) Visual inspection of fits (estimation of λ-z) Wetware 🧠 vs. software 🤖 Manual integrations Manual int	NCA / SHAM	Helmut	2025-11-15 12:36	4	2025-11-17 09:35	2,327
September trouble September trouble More months trouble More months trouble Know the month abbreviations Know the month abbreviations Worse in France Worse in France	🇷 for BE/BA	ElMaestro	2025-11-10 12:26	7	2025-11-14 16:38	3,022
ICHM13A/Multiple Test Product Studies α-adjustments? α-adjustments? α-adjustments? Beyond Bonferroni…	Regulatives / Guidelines	Mikkabel	2025-11-04 09:46	4	2025-11-10 08:56	2,420
Comparing two plasma concentration profiles Comparing two plasma concentration profiles Comparing two plasma concentration profiles Comparing two plasma concentration profiles Comparing two plasma concentration profiles MathJax Formulas… Formulas… Negative ƒ2 is possible Interesting, however... Negative ƒ2 is possible	Study Assessment	Darborn	2025-10-17 05:40	10	2025-11-07 06:04	4,049
New ICH M13a guidance on BE analysis ICH M13A (EMA, FDA, HC)	Regulatives / Guidelines	jag009	2025-10-17 21:04	1	2025-10-18 12:24	2,251
long half-life AUC0-t or AUC0-72 IR with t½ ≥ 24 h IR with t½ ≥ 24 h long half life product? long half life product? long half-life AUC0-t or AUC0-72 long half-life AUC0-t or AUC0-72	NCA / SHAM	Darborn	2025-10-14 05:34	6	2025-10-17 05:16	3,078
Point Estimate consideration in sample size estimate Point Estimate consideration in sample size estimate Point Estimate consideration in sample size estimate BE = CI within acceptance range (PE is irrelevant) BE = CI within acceptance range (PE is irrelevant) BE = CI within acceptance range (PE is irrelevant) BE = CI within acceptance range (PE is irrelevant)	Power / Sample Size	kimhuang	2025-10-09 07:21	6	2025-10-16 09:37	3,464
Can we administer generic drug as concomitant in patient based PK study	Regulatives / Guidelines	narra1813	2025-10-14 13:20	0		1,331
Bug in function power.TOST() Bug in function power.TOST() Bug in function power.TOST() Bug in function power.TOST() fixed	🇷 for BE/BA	Helmut	2025-08-22 10:28	3	2025-10-06 09:59	4,193
Guideline on the requirements for demonstrating Therapeutic equivalence between orally inhaled products (OIP) for asthma	Regulatives / Guidelines	qualityassurance	2025-09-25 07:41	0		1,546
Sequences of BE study under both fasting and fed studies Sequences of BE study under both fasting and fed studies Sequences of BE study under both fasting and fed studies Fed → fasting Fed (failed) → fasting (succeeded) Fed (failed) → fasting (succeeded)	Design Issues	A.Shtaiwi	2025-09-03 12:40	5	2025-09-23 15:35	4,483
Introduction into basic principles of clinical PK	Conferences / Workshops	Helmut	2025-09-18 09:53	0		1,701
Phoenix: What to do if pre-dose is greater than the peak conc Phoenix: Data please!	Software	jag009	2025-09-16 04:29	1	2025-09-16 21:51	2,430
Batch acceptance with revised LLOQ Interference in blanks Batch acceptance with revised LLOQ	Bioanalytics	shreyas goswami	2025-08-19 04:22	2	2025-09-12 10:28	3,585
Lupron shelf life or expiration date Lupron shelf life or expiration date Lupron shelf life or expiration date Shelf-life 🇦🇹 🇳🇿 (similar in 🇪🇺?) Shelf-life 🇦🇹 🇳🇿 (similar in 🇪🇺?) Shelf-life (≠ Lupron!)	Regulatives / Guidelines	Achievwin	2025-08-08 12:25	5	2025-08-14 15:25	5,029