Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Silodosin	arl_stat	2016-02-02 07:07	0		3,982
Montelukast BE study Montelukast BE study Opinions ... Opinions ... Montelukast BE study MHRA’s PARs MHRA’s PARs CV from the CI CI2CV Beyond the abstract Beyond the abstract Beyond the abstract & Kinetica Beyond the abstract & Kinetica Partial credit Partial credit Partial credit Partial credit	rahul dixit	2011-01-03 15:17	16	2016-01-22 14:06	21,644
Azithromycin Azithromycin Azithromycin Azithromycin Azithromycin Azithromycin Azithromycin	mayur661	2010-06-02 15:05	6	2016-01-13 10:01	8,911
Trientine Hydrochloride capsules BE study	krish	2016-01-06 06:34	0		5,780
Enzalutamide Which regulatory agency?	pash413	2015-12-07 13:22	1	2015-12-07 16:59	6,829
cortisol suppression as clinical endpoint cortisol suppression as clinical endpoint cortisol suppression as clinical endpoint cortisol suppression as clinical endpoint cortisol suppression as clinical endpoint cortisol suppression as clinical endpoint cortisol suppression as clinical endpoint cortisol suppression as clinical endpoint cortisol suppression as clinical endpoint cortisol suppression as clinical endpoint cortisol suppression as clinical endpoint cortisol suppression as clinical endpoint cortisol suppression as clinical endpoint cortisol suppression as clinical endpoint	lizhao	2014-09-10 23:21	13	2015-12-02 22:00	16,109
sample size for clinical endpoint BE study of Brinzolamide 1% ophthalmic general remark Specific remarks Specific remarks	kishpokuri	2015-11-24 14:18	3	2015-11-27 12:46	8,163
Positive Pre-dose in subsequent period of long acting depot injection Exclusion of subjects Positive Pre-dose in subsequent period of long acting depot injection Positive Pre-dose in subsequent period of long acting depot injection Expected loss in power	Compliance	2015-10-14 12:54	4	2015-10-15 11:45	9,354
sparse sample design sparse sampling ⇒ population PK sparse sampling ⇒ population PK incomplete ≠ sparse	Mahesh M	2015-10-14 12:03	3	2015-10-14 13:14	7,507
Designing of food effect & bio-availability study Designing of food effect & bio-availability study	Vyas	2015-10-08 11:08	1	2015-10-08 15:28	5,826
Alimemazine (Trimeprazine) PK linearity and BCS class Alimemazine (Trimeprazine) PK linearity and BCS class	pjs	2015-06-25 11:15	1	2015-09-03 13:27	7,682
Indications for different BE-designs Effects and adverse effects Effects and adverse effects	BE-proff	2015-08-17 11:59	2	2015-08-18 06:26	5,939
EMA HVD/HVDPs EMA HVD/HVDPs An applicant suspects… Paranoia? Blindness!	Helmut	2015-08-16 13:27	4	2015-08-17 13:02	7,786
R-SABE and ABEL versus Blood Volume R-SABE and ABEL versus Blood Volume R-SABE and ABEL versus Blood Volume R-SABE and ABEL versus Blood Volume R-SABE and ABEL versus Blood Volume	Lucas	2015-08-11 16:06	4	2015-08-11 16:26	7,368
Sample size justification Sample size justification PASS simulator? PASS simulator? Owen’s Q \| noncentral t \| shifted central t Owen’s Q \| noncentral t \| shifted central t PowerTOST crash-course Owen’s Q \| noncentral t \| shifted central t - PASS? Sample size justification Sample size justification Guesstimates Guesstimates Guesstimates Guesstimates	bkrao	2015-08-06 09:12	13	2015-08-10 18:44	14,974