Bioequivalence and Bioavailability Forum

Subject	Category	Author	Date	Replies	last	Views
2012 events listing 3rd World Congress on BABE-2012, 26-28 March, Hyderabad 2nd World Congress Going Off-Topic ♠♣♥♦ 2nd World Congress Courses by Stephen Senn 2nd Open Forum on Pharmaceutics and Biopharmaceutics	Conferences / Workshops	HS	2011-10-10 03:15	6	2012-03-22 10:17	4067
Guidance Documents ...other Sources Requests for Update Questions for regulatory requirements… Redesign of FDA’s website :-(	Regulatives / Guidelines	HS	2006-01-20 23:28	4	2009-06-08 15:24	26418
In-vitro equivalence In-vitro equivalence In-vitro equivalence	General Statistics	martin	2012-05-17 15:10	2	2012-05-19 10:28	78
FDA regulation on Overage of drug product FDA regulation on Overage of drug product	Regulatives / Guidelines	jag009	2012-05-18 21:05	1	2012-05-19 02:02	38
Bioequivalence study on Psychotropic drugs Bioequivalence study on Psychotropic drugs Bioequivalence study on Psychotropic drugs Bioequivalence study on Psychotropic drugs Bioequivalence study on Psychotropic drugs Bioequivalence study on Psychotropic drugs	Regulatives / Guidelines	drchilkoti	2012-04-11 06:35	5	2012-05-18 13:41	330
how to use Loo Riegelman method and deconvolution how to use Loo Riegelman method and deconvolution	Dissolution / BCS/IVIVC	laili	2012-05-07 09:40	1	2012-05-18 12:32	149
Forced Degradation study of Hydrocortisone	Design Issues	Ravindran S	2012-05-18 06:13	0		44
FDA: In-Vitro Alcohol testing of modified release product FDA: In-Vitro Alcohol testing of modified release product	Regulatives / Guidelines	jag009	2012-05-16 16:22	1	2012-05-17 10:08	91
Several group design with unequal washout Several group design with unequal washout Hidden Q? Q unveiled Q or not Q ? "." ≠ "?" Several group design with unequal washout Several group design with unequal washout Thai FDA Thai FDA Thai FDA Thai FDA	Design Issues	sarawut	2012-05-08 12:36	11	2012-05-16 19:02	347
Omeprazole Omeprazole Omeprazole	Design Issues	joyjac	2012-05-15 09:22	2	2012-05-15 19:00	190
Damn good breakfast if you ask me or looking for a free pass Damn good breakfast if you ask me or looking for a free pass Damn good breakfast if you ask me or looking for a free pass	Regulatives / Guidelines	The Outlaw Torn	2012-05-14 15:34	2	2012-05-15 07:37	150
Criteria check assessment of subjects Criteria check assessment of subjects Criteria check assessment of subjects Criteria check assessment of subjects Criteria check assessment of subjects Criteria check assessment of subjects Criteria check assessment of subjects	GxP / QC / QA	kapil pandya	2010-11-12 12:43	6	2012-05-14 15:35	1157
Parallel study as pilot for long half life drug Parallel study as pilot for long half life drug Parallel study as pilot for long half life drug Parallel study as pilot for long half life drug AUC72 AUC72 AUC72 AUC72 AUC72: NDAs AUC72: NDAs	Design Issues	jag009	2012-05-07 15:13	9	2012-05-14 15:22	335
Sample Size from Interaction study Sample Size from Interaction study Sample Size from Interaction study Uncertainty of CVs; AUC72 - actual vs. nominal time Uncertainty of CVs; AUC72 - actual vs. nominal time Uncertainty of CVs; AUC72 - actual vs. nominal time Uncertainty of CVs; AUC72 - actual vs. nominal time	Power / Sample Size	jag009	2012-05-10 16:14	6	2012-05-11 18:13	258
Blinding in Canadian BE Study Blinding in Canadian BE Study Blinding in Canadian BE Study Blinding in Canadian BE Study Blinding in Canadian BE Study	Regulatives / Guidelines	pravin17	2012-05-09 09:07	4	2012-05-11 06:16	247
EMEA Widening of acceptance limit EMEA Widening of acceptance limit EMEA Widening of acceptance limit EMEA Widening of acceptance limit	Regulatives / Guidelines	hiren379	2012-05-02 08:39	3	2012-05-10 13:22	283
How many calibration curve and how many day for precision	Bioanalytics	sarawut	2012-05-10 07:57	0		119
Full replicate design Full replicate design Full replicate design HVDs/HVDPs: tricky business! HVDs/HVDPs: tricky business! HVDs/HVDPs: tricky business! Ratio 125% Ratio 125% Ratio 125%: reformulate Ratio 125%: reformulate HVDs/HVDPs: tricky business! HVDs/HVDPs: tricky business!	Design Issues	PTM139	2012-05-03 06:01	11	2012-05-10 05:49	449
Withdrawal Criteria as per Canadian Guideline	Regulatives / Guidelines	pravin17	2012-05-08 13:42	0		147
SAS error in 3 way ref replicate study SAS error in 3 way ref replicate study SAS error in 3 way ref replicate study FDA's ABE code and partial replicate design Arbitrary (and unjustified) cut-off of r² Anscombe quartet Anscombe quartet in R Anscombe quartet in R	Software	AB	2012-05-04 15:13	7	2012-05-07 12:07	363
Bioanalytical work - GLP still needed? Bioequivalence: GCP + GLP	Regulatives / Guidelines	AUClast	2012-05-04 10:59	1	2012-05-04 11:19	241
Factors Affecting Tmax Factors Affecting Tmax	PK Metrics	jag009	2012-05-03 23:00	1	2012-05-04 06:04	207
Compartmental modelling Hybrid constants in iv and ev models Hybrid constants in iv and ev models	PK Metrics	jag009	2012-05-01 19:55	2	2012-05-03 22:54	231
Facility Approvals Facility Approvals Facility Approvals GCP vs. GLP JFDA Facility Approvals GCP vs. GLP	Regulatives / Guidelines	akinapally	2012-05-03 14:23	4	2012-05-03 21:27	262
Partial replicate design Partial replicate design Partial replicate design	Design Issues	PTM139	2012-05-03 05:58	2	2012-05-03 16:38	229
Subject within sequence effects Subject within sequence effects Subject within sequence effects Subject within sequence effects Should concentrate on brewing	General Statistics	Dr Andrew Leary	2012-05-02 17:48	4	2012-05-03 11:46	296
Inter Subject Variability What for? What for? ANVISA…	Power / Sample Size	saimsc007	2012-05-02 11:46	3	2012-05-02 14:57	294
History Lesson: FDA BA/BE guidance History Lesson: FDA BA/BE guidance History Lesson: FDA BA/BE guidance	Regulatives / Guidelines	jag009	2012-04-18 17:26	2	2012-05-01 13:23	591
permeability testing and biowaiver permeability testing and biowaiver permeability testing and biowaiver permeability testing and biowaiver	Dissolution / BCS/IVIVC	Compliance	2012-04-28 13:13	3	2012-04-30 20:08	259
Phases of Clinical Trial Learn to google ;-) Learn to google ;-) Other fora more appropriate?	Design Issues	atulsakariya	2012-04-30 12:22	3	2012-04-30 13:01	259
Parallel study design Parallel study design (AEs)	Design Issues	Compliance	2012-04-28 11:29	1	2012-04-28 11:47	193
Reference replicate design Use FDA’s SAS code!	Software	dinesh prabhu	2012-04-28 06:24	1	2012-04-28 11:38	205
which SAS code to use As slow as possible Some school math Some school math	Software	AB	2012-04-27 14:38	3	2012-04-28 07:13	369
power calculation for partial /full replicate study designs Useless power Useless power Useless power: over & over again Useless power: over & over again What for?	Regulatives / Guidelines	balakotu	2012-04-02 15:06	5	2012-04-28 03:12	467
phenytoin sodium BE study phenytoin sodium BE study phenytoin sodium BE study phenytoin sodium BE study	Regulatives / Guidelines	jagankm	2012-04-24 11:54	3	2012-04-26 15:54	882