Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
Oxcarbazepine Tablet Study design ABE or ABEL for Health Canada Oxcarbazepine Tablet Study design Health Canada ABEL Oxcarbazepine Tablet Study design Oxcarbazepine Tablet Study design	Design Issues	AB661	2024-07-13 09:02	5	2024-08-24 12:19	3,017
EU Reference Medicinal Product – Flexible or Absolute? EEA Reference Medicinal Product: Mandatory	Regulatives / Guidelines	PE	2024-08-20 10:39	1	2024-08-20 12:17	1,939
Predose concentration more than 5 % of Cmax FDC or isomers: C0 > 5 % of Cmax FDC or isomers: C0 > 5 % of Cmax Carryover. A Never Ending Story. Inducers/inhibitors Inducers/inhibitors Predose concentration more than 5 % of Cmax	Regulatives / Guidelines	NK	2024-08-05 06:07	6	2024-08-09 08:26	2,861
A boring question about bioavailability? ƒ of IV = 1 by definition, but… ƒ of IV = 1 by definition, but… IV: Different half-lives? IV: Different half-lives? IV: Liposome encapsuled drug, pegylated biologic? IV: Liposome encapsuled drug, pegylated biologic?	Off Topic	Darborn	2024-08-01 09:05	6	2024-08-06 05:15	3,063
Fed conditions → timing of meal ICH M13A ICH M13A ICH M13A published ICH M13A published ICH M13A published ICH M13A published ICH M13A published ICH M13A published ICH M13A published ICH M13A published	Design Issues	zuzanna	2024-07-31 07:54	10	2024-08-05 12:45	3,658
SAS code of partial replicate design Etiquette SAS code for what? partial replicate = 3-period replicate partial replicate = 3-period replicate 3-period replicate designs and SAS Extra-reference or partial replicate design Extra-reference or partial replicate design Simple minded Simple minded SAS and WinNonlin SAS and WinNonlin SAS and WinNonlin Phoenix RSABE-template Phoenix RSABE-template CVw in Phoenix RSABE-template CVw in Phoenix RSABE-template CVw in Phoenix RSABE-template and PowerTOST CI2CV() CVw in Phoenix RSABE-template and PowerTOST CI2CV() General ABE? General ABE? Switchability and Prescribability in WinNonlin PBE and IBE in WinNonlin PBE and IBE in WinNonlin Switchability	Software	pa1kumar.anna	2008-12-01 09:51	24	2024-08-01 05:45	34,141
FDC with ascorbic acid FDC with ascorbic acid FDC with ascorbic acid Placebo? Placebo? 🇦🇹 AGES Placebo? Sorry – wrong addressee lucky	Regulatives / Guidelines	qualityassurance	2024-07-23 08:08	8	2024-07-24 16:01	3,092
Bizarre offer A name of the book A name of the book A name of the book A name of the book Bizarre offer	Off Topic	Helmut	2024-07-05 08:37	5	2024-07-23 19:56	3,412
Brazil, Mexico: Proc GLM or Proc Mixed? Brazil, Mexico: Proc GLM? Mexico: new guideline Mexico: ABEL Mexico: ABEL Mexico: ABEL Mexico: ABEL	Regulatives / Guidelines	jag009	2024-07-17 20:29	6	2024-07-23 19:43	3,194
Difference between compartmental and Noncompartmental WinNonlin: PK and NCA Difference between compartmental and Noncompartmental Difference between compartmental and Noncompartmental Difference between compartmental and Noncompartmental Micro ⇒ macro for Deconvolution fans	Software	Hari	2007-07-11 09:47	6	2024-07-23 15:02	12,883
FARTSSIE 3.0 FARTSSIE 3.0 FARTSSIE 3.0: Excel 365 @Win 11 & Excel 2000 (‼) @Win 7 FARTSSIE 3.0: Excel 2021 @Win 10 FARTSSIE 3.0: Excel 2021 @Win 10 Windows GPO Windows GPO	Software	Helmut	2024-06-19 14:55	6	2024-07-22 05:16	3,217
full replicate study for drug not highly variable - EMA perspective EMA: Full replicate study	Regulatives / Guidelines	Ankit Parikh	2024-07-11 04:40	1	2024-07-15 09:13	2,439
Need some clarity on eCTD module 5	Regulatives / Guidelines	jag009	2024-07-12 16:04	0		1,424
Fed dissolution with 20% glucose	Dissolution / BCS / IVIVC	yuva	2024-07-11 08:55	0		1,579
How to calculate %dissolved using USP Apparatus 4 (Open loop system)?	Dissolution / BCS / IVIVC	rezkighassani	2024-07-11 07:50	0		1,409