Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
Three-way crossover BABE Studies Three-way crossover example data set Three-way crossover example data set Three-way crossover example data set Three-way crossover (WinNonlin) Three-way crossover (WinNonlin) Three-way crossover (WinNonlin) Three-way crossover (WinNonlin) Three-way crossover example data set Three-way crossover example data set Three-way crossover example data set Three-way crossover example data set Leave-One-Out (IBD) Leave-One-Out (IBD) Impact of pooled variance (bias, CI) carry (over?) Pseudo-periods Pseudo-periods Two‐at‐a‐Time analysis in R fixed & mixed (dammit!) and a request to SASians Pooled vs IBD T-R in SAS from non-SASian Pooled vs IBD T-R in SAS from non-SASian mixed in R mixed in R (EMA B ≠ FDA)	acfalcao	2007-09-16 22:34	23	2019-03-24 01:23	14,603
Can we have two primary objectives? Can we have two primary objectives?	Achievwin	2019-01-24 17:50	1	2019-01-25 09:55	415
Acetylsalicyclic Acid + Glycine Tablet	Ramesh Ramalingam	2019-01-21 11:33	0		268
Dextromethorphan 90 mg in a single dose Dextromethorphan 90 mg in a single dose	heritage	2018-11-24 15:36	1	2018-11-26 10:33	681
BMI BMI limits BMI limits BMI limits BMI limits BMI limits	Amira Gouda	2018-10-30 10:48	5	2018-10-31 13:59	906
flibanserin: sample size	mokhtar saleh	2018-10-28 12:34	0		449
Theophylline ER 450 mg study design	Ramesh Ramalingam	2018-10-18 07:16	0		494
Reference drug product for Captopril / Hydrochlorothiazide	A-M-R	2018-10-17 14:46	0		405
Product-specific advice (steroid nasal sprays) Product-specific advice (steroid nasal sprays) Product-specific advice (steroid nasal sprays) Product-specific advice (steroid nasal sprays)	Mikalai	2018-10-16 13:42	3	2018-10-17 11:56	733
Regulatory submissions T vs. R1 and T vs. R2 T vs. R1 and T vs. R2	rajasekharkakarla	2018-09-14 14:13	2	2018-09-17 06:57	1,158
Bio Batch Size Bio Batch Size	fedesalas	2018-09-12 17:46	1	2018-09-13 00:19	856
Generic FDC drug vs two monoproduct drug or vs "originator" FDC drug? Generic FDC: EMA-approach Generic FDC: EMA-approach Generic FDC: EMA-approach Generic FDC: EMA-approach	Beholder	2018-09-04 11:12	4	2018-09-04 15:23	1,231
Sampling time Sampling time Sampling time Sampling time	drp	2018-08-10 07:09	3	2018-08-18 00:17	1,401
Multiple Dose, Steady State-Partial reference replicate Multiple Dose, Steady State-Partial reference replicate Logistic nigthmare Multiple Dose, Steady State-Partial reference replicate	arl_stat	2018-07-13 13:26	3	2018-07-17 06:34	1,407
Cloperastine ISCV Cloperastine ISCV Cloperastine ISCV Cloperastine ISCV Manufacturer’s PK data (investigator’s brochure) Cloperastine ISCV Cloperastine ISCV	Mauricio Sampaio	2015-03-31 18:59	6	2018-07-13 12:09	10,874