Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
food viscosity requirement for fed state BE study as per US Viscosity?! No problem!	sam	2012-10-10 10:53	2	2012-10-10 12:25	3,577
Registration with Turkey Registration with Turkey Registration with Turkey	yogesh1004	2012-10-09 18:47	2	2012-10-10 11:06	3,252
Mesalamine pAUC Mesalamine pAUC Mesalamine pAUC	jag009	2012-10-05 22:37	2	2012-10-05 21:00	3,542
when do DCGI require preclinical toxicity data	AB	2012-10-04 12:45	0		2,081
Fed study Fed study Fed study Fed study Fed study Fed study	dixit	2012-09-24 10:35	5	2012-10-01 08:52	3,777
Deficiency response Deficiency response CMDh reminder CMDh reminder CMDh reminder CMDh reminder Long-term storage samples? CMDh reminder CMDh reminder CMDh reminder CMDh reminder 90%+ off-topic 90%+ off-topic	kamblpa2	2012-08-13 10:33	12	2012-09-29 07:30	6,167
Method validation sample outlier	konkous	2012-09-28 13:43	0		1,618
Expedited review from IEC Expedited review from IEC Expedited review from IEC Similar ≠ same	vivekanand	2012-09-26 06:55	3	2012-09-26 13:03	3,258
USFDA requirement for randomization randomization: validation randomization: runs test? validation? randomization: runs test? validation? probability nearly zero? probability nearly zero! R-package randomizeBE R-package randomizeBE randomization: validation randomization: runs test randomization: runs test randomization: runs test very cool coding style Better a good steal than a bad reinvention Better a good steal than a bad reinvention Sorry! Sorry! Dancing with the dice Silly's randomization 2x2 xover Silly's randomization 2x2 xover Clumsy code Clumsy code Speed kills Speed kills	Ravi	2012-06-15 13:39	23	2012-09-17 19:46	17,977
BE study – 3×6 design BE study – 3×6 design	manu126	2012-09-14 08:33	1	2012-09-17 15:32	2,358
Multiple dose studies waived based on single dose studies Multiple dose studies waived based on single dose studies MD waiving based on SD 90–111% CI unlikely	rana	2012-09-14 11:32	2	2012-09-14 12:05	3,101
BE analysis – sensitivity analysis BE analysis – sensitivity analysis	manu126	2012-09-14 08:23	1	2012-09-14 07:14	2,502
Retention period of Investigational products and documents	vivekanand	2012-09-13 07:10	0		1,761
DMF open part of Levothyroxine	Jasim Uddin	2012-09-07 15:32	0		1,773
COA for Reference Product COA for Reference Product COA for Reference Product COA for Reference Product	Jasim Uddin	2012-09-04 12:11	3	2012-09-07 13:26	3,960