Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Regulatory Query for study repeat Repeats Repeats Repeats Repeats Repeats Repeats Bad science Bad science Posting style & incomplete information Posting style & incomplete information RTFM! RTFM! copy & paste error or what? copy & paste error or what? Calm down! Slightly off-topic: The wonders of pilot trials Futility rule? Futility rule? Slightly off-topic: The wonders of pilot trials PE of AUC? PE of AUC? EOD Posting style & incomplete information Posting style & incomplete information Bad science Repeats Repeats Regulatory Query for study repeat Regulatory Query for study repeat Regulatory Query for study repeat More questions..	sam	2013-07-27 07:50	31	2013-07-30 14:53	22,238
Add more subjects after a failed BE study of a HVD bad luck bad luck Beware of Add-on Studies! Beware of Add-on Studies! Oh wow! The same criterion of Cmax in China now SFDA ⇒ CFDA Helmut, updated Chinese BE guideline here BE in Chinese Pharmacopoeia BE in Chinese Pharmacopoeia BE in Chinese Pharmacopoeia Add more subjects after a failed BE study of a HVD Still many subjects…	wxp	2013-05-27 10:34	13	2013-06-14 14:11	14,699
Interesting Data from HVD study Detlew? What is the question? Answer: forget the partial replicate! What is the question?	jag009	2013-05-16 22:15	4	2013-06-04 14:04	7,691
Question about subject with very few timepoints Reliable profile Reliable profile Reliable profile CVintra result of outlier	jag009	2013-04-25 17:45	4	2013-04-26 06:58	5,048
First point Cmax First point Cmax First point Cmax Search, search ...	Smitha	2012-12-04 09:36	3	2012-12-09 18:16	6,862
Deviation in predose fasting duration of 10 hours Deviation in predose fasting duration of 10 hours	scorp2011	2012-10-30 10:14	1	2012-11-01 09:11	4,512
Failure of BE in fasting studies Failure of BE in fasting studies Failure of BE in fasting studies Failure of BE in fasting studies Different designs: why not? Different designs: why not? Failure of BE in fasting studies Failure of BE in fasting studies Failure of BE in fasting studies Failure of BE in fasting studies 1–β not necessarily = Δ Sample size +partial replicate	ABE1580	2012-10-09 15:42	12	2012-10-12 08:42	11,284
high concentration in the elimination phase-Metaxalone high concentration in the elimination phase-Metaxalone high concentration in the elimination phase-Metaxalone Enterohepatic recirculation Enterohepatic recirculation Enterohepatic recirculation high concentration in the elimination phase-Metaxalone high concentration in the elimination phase-Metaxalone high concentration in the elimination phase-Metaxalone	cakhatri	2012-09-07 05:58	8	2012-09-14 04:30	10,599
First point Cmax First point Cmax First point Cmax First point Cmax First point Cmax	auditor	2012-02-10 06:50	4	2012-09-10 11:54	9,407
To calculate AUC0-inf in Scaled average bioequivalence Completely lost sequence in partial replicate	aquapurple	2012-08-24 11:50	1	2012-08-24 18:07	5,152
Statistical Out come Statistical Out come Statistical Out come	auditor	2012-02-01 12:58	2	2012-02-02 18:13	4,887
Predose concentration more than 5 % of Cmax Exclusion of subjects (predose >5 % of Cmax)	kamblpa1	2011-12-27 05:19	1	2011-12-27 17:35	7,581
pre-dose concentrations above LLOQ pre-dose concentrations above LLOQ pre-dose concentrations above LLOQ pre-dose concentrations above LLOQ pre-dose concentrations above LLOQ pre-dose concentrations above LLOQ	Paola	2011-12-21 12:58	5	2011-12-22 21:06	8,176
Pre Treatment drug levels Pre Treatment drug levels Pre Treatment drug levels Protocol Deviation	JOI	2011-11-16 11:57	3	2011-11-16 17:11	6,581
Redosing study… Redosing study… Redosing study… Redosing study… Redosing study… Redosing study… Redosing study… Redosing study… Redosing study… Redosing study… Redosing study… Redosing study…	H.Patel	2011-06-15 16:28	11	2011-06-18 09:53	12,061