Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
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	13,818
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	5,651
First point Cmax First point Cmax First point Cmax Search, search ...	Smitha	2012-12-04 09:36	3	2012-12-09 18:16	8,293
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	6,607
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	9,373
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	18,119
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	27,189
AUCextrap more than 20% AUCextrap more than 20% AUCextrap more than 20% AUCextrap more than 20% AUCextrap more than 20% AUCextrap more than 20% forced BE Gambling ♠ ♣ ♥ ♦ AUCextrap more than 20% AUCextrap more than 20% 46% power in study planning? 46% power in study planning? 46% power in study planning? Re-dosing Re-dosing Re-dosing 46% power in study planning? Carved in stone? Carved in stone? Carved in stone? Carved in stone? Ethics (again) Update Update Update Outliers (CAN) Outliers (CAN) OT: Expert Update Update Update Update Update	sam	2013-08-01 06:15	32	2013-08-05 18:14	32,714
I thought I have seen everything I thought I have seen everything I thought I have seen everything Gimme some data! Gimme some data! Gimme some data! Gimme some data!	jag009	2013-08-19 20:40	6	2013-08-20 17:54	10,989
Failed AUC 0-t Failed AUC 0-t Failed AUC 0-t bear for replicates Failed AUC 0-t Failed AUC 0-t Correct numbers? Failed AUC 0-t	Tina	2013-08-29 09:25	7	2013-08-30 07:23	12,739
high dropout for vomiting high dropout for vomiting	zheng791	2013-09-26 16:13	1	2013-09-27 07:59	5,200
Failed Fed study on Indapamide MR Failed Fed study on Indapamide MR Failed Fed study on Indapamide MR CV from CI CV from CI Misprint gremlin Failed Fed study on Indapamide MR Failed Fed study on Indapamide MR Failed Fed study on Indapamide MR Failed Fed study on Indapamide MR Failed Fed study on Indapamide MR Failed Fed study on Indapamide MR Failed Fed study on Indapamide MR Failed Fed study on Indapamide MR	Clarc	2013-11-19 11:04	13	2013-11-21 06:11	16,102
Failed study No sample size estimation in protocol? No sample size estimation in protocol? Failed study Failed study Failed study Failed study Failed study Failed study Failed study	myy	2014-03-07 16:19	9	2014-03-10 16:44	13,678
Influence of sampling points on CV intra Influence of sampling points on CV intra Influence of sampling points on CV intra	Averroes	2014-03-31 17:48	2	2014-04-02 23:09	6,349
Changes in halflife Changes in halflife	Tina	2014-05-01 10:28	1	2014-05-03 05:20	5,077