Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
▼ Read before registering ▼	Tips / Tricks	Helmut	2016-04-14 23:39	0		53,593
effectiveness of highly variable drugs HVDs/HVDPs = safe drugs HVDs/HVDPs = safe drugs effectiveness of highly variable drugs effectiveness of highly variable drugs effectiveness of highly variable drugs Period effect Period effect Period effect Period effect Period effect	Off Topic	Ken Peh	2013-12-17 03:45	10	2019-02-22 12:23	8,396
bear v2.7.8 released (GUI) bear v2.7.8 released (GUI) install GTK+ driver for bear install GTK+ driver for bear install GTK+ driver for bear strange misc.pk for replicate strange misc.pk for replicate bear v2.8.3-3 released	R for BE/BA	yjlee168	2017-04-13 21:58	7	2019-02-21 20:47	6,198
inter-batch variability? inter-batch variability? inter-batch variability? inter-batch variability? Between study variability common for HVDs Between study variability common for HVDs Representative batches? Representative batches? Representative batches? Representative batches? Representative batches? Confidence intervals vs. point estimators Confidence intervals vs. point estimators Confidence intervals vs. point estimates Confidence intervals vs. point estimators Confidence intervals vs. point estimators meta analysis? meta analysis? meta analysis? meta analysis? No chance against RMS? No chance against RMS? Batch-to-Batch Pharmacokinetic Variability tlast (Common) tlast (Common) tlast (Common) tlast (Common) tlast (Common) tlast (Common)	Regulatives / Guidelines	Dr_Dan	2010-08-04 10:29	28	2019-02-21 18:17	7,830
CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? CV values in BE studies: intra, or inter, or total? PowerTOST: CVfromCI PowerTOST: CVfromCI -> CI.BE Oops! Oops! df? Oops! df? Oops! df! Oops! df? Oops! df? All the answers are here PowerTOST: CVfromCI type known.designs() in PowerTOST type known.designs() in PowerTOST	Study Assessment	Elena777	2018-01-20 12:31	22	2019-02-21 14:49	3,907
Representation of BQL values in concentration data Representation of BQL values in concentration data Representation of BQL values in concentration data Representation of BQL values in concentration data	Bioanalytics	GM	2019-02-21 06:28	3	2019-02-21 08:15	83
Health Canada Study reports	Regulatives / Guidelines	anky1212	2019-02-21 05:05	0		54
AUC0-tau at steady state AUC0-tau at steady state AUC0-tau at steady state RTFM RTFM AUC0-τ estimation with time deviations AUC0-τ estimation with time deviations Cτ for lin and lin-up/log-down Cτ by lin-/lin, lin-up/log-down, and λz inter- vs extra- inter- vs extra- No rule fits all one size fits all vs goal posts one size fits all vs goal posts Bias etc. software: NCA not validated no way out for NCA validation? Default rules	NCA / SHAM	BNR	2016-03-31 22:46	17	2019-02-20 21:40	5,370
calibration curve range calibration curve range calibration curve range calibration curve range calibration curve range calibration curve range calibration curve range calibration curve range	Bioanalytics	Ladi	2016-02-23 09:22	7	2019-02-20 18:32	4,349
Thalidomide	Study Assessment	Rosy	2019-02-19 23:09	0		71
Trinidad and Tobago Bio-equivalence guidelines	Regulatives / Guidelines	varun9461	2019-02-18 11:56	0		112
Dose curve	PK / PD	Sundar.M	2019-02-15 13:37	0		113
Outlier Tests Outlier Tests Outlier Tests Outlier Tests Outlier Tests Outlier Tests	Outliers	GM	2018-07-30 13:57	5	2019-02-15 04:58	993
Dabigatran EMA - product-specific guide Dabigatran EMA - product-specific guide OT: A major loss OT: A major loss OT: A major loss OT: A major loss Dabigatran EMA - product-specific guide Dabigatran EMA - product-specific guide Dabigatran EMA - product-specific guide Dabigatran EMA - product-specific guide	Regulatives / Guidelines	nobody	2019-02-13 18:58	9	2019-02-14 15:01	354
AUC <5% of TEST geometric mean AUC AUC <5% of TEST geometric mean AUC AUC <5% of TEST geometric mean AUC AUC <5% of TEST geometric mean AUC	Outliers	vezz	2019-02-13 08:35	3	2019-02-13 12:09	207
FDA: RSABE for NTID FDA: RSABE for NTID FDA: RSABE for NTID FDA: RSABE for NTID FDA: RSABE for NTID β = 1 – π Warfarin Sodium 95% Upper bound criteria Upper bound in RSABE ≤0 Upper bound in RSABE ≤0	RSABE / ABEL	Jay	2018-03-26 13:31	8	2019-02-12 07:10	2,659

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