Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
A dumb question A dumb answer A dumb answer A dumb answer A dumb answer A dumb answer An alternate dumb answer An alternate dumb answer Unconjugated ≠ free Unconjugated ≠ free A dumb question	Bioanalytics	jag009	2024-08-12 13:17	10	2024-08-27 03:02	1,244
Leuprolide 1 month product shelf life	Design Issues	Achievwin	2024-08-27 02:47	0		273
Acute and Sub-acute toxicity studies for FDA ANDAs Acute and Sub-acute toxicity studies for FDA ANDAs Acute and Sub-acute toxicity studies for FDA ANDAs	Regulatives / Guidelines	Achievwin	2024-08-05 18:50	2	2024-08-27 02:42	768
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	1,475
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	709
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	1,121
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	1,287
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	1,621
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	31,333
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	1,335
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	2,049
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	1,326
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	11,373
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	1,602
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	1,116