Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
September 2019: 34 new and 19 revised product-specific FDA BE guidelines	BE/BA News	nobody	2019-09-24 10:58	0		345
Two 2x2 and one 6x3 crossover design Two 2x2 and one 6x3 crossover design	Design Issues	qzhou	2019-09-24 04:20	1	2019-09-24 10:57	409
Crossover: samples of p1 and p2 in different batches? Crossover: samples of p1 and p2 in different batches? Leads to a (pseudo-) period effect Leads to a (pseudo-) period effect ? Leads to a (pseudo-) period effect ? Leads to a (pseudo-) period effect ? Almost entirely OT Almost entirely OT Completely OT Leads to a (pseudo-) period effect ? Leads to a (pseudo-) period effect ? Run ≠ batch? Run ≠ batch Run ≠ batch? Run ≠ batch? Leads to a (pseudo-) period effect	Bioanalytics	Ravuri sindhura	2019-09-18 19:16	15	2019-09-23 13:04	1,082
steady state for modified release steady state for modified release	Regulatives / Guidelines	Kelen	2019-09-20 20:04	1	2019-09-23 10:04	517
Dissolution Media for Comparative Dissolution Study	Dissolution / BCS / IVIVC	ilee9009	2019-09-20 11:00	0		321
Equivalency Studies for Injectables	Design Issues	ilee9009	2019-09-20 10:24	0		277
0 hr Pre-dose concentration but less than 5% of Cmax 0 hr Pre-dose concentration but less than 5% of Cmax 0 hr Pre-dose concentration but less than 5% of Cmax Reanalysis if possible Reanalysis if possible >6 sources of matrix >6 sources of matrix >6 sources of matrix >6 sources of matrix Flashback Flashback No correction if ≤5% Cmax No correction if ≤5% Cmax excluded period(s) excluded period(s)	Regulatives / Guidelines	jag009	2012-03-29 19:34	14	2019-09-20 07:57	6,326
Reference replicated designs	Regulatives / Guidelines	rajasekharkakarla	2019-09-20 06:35	0		322
Appropriate wording for a protocol Appropriate wording for a protocol Appropriate wording for a protocol Appropriate wording for a protocol Which country? Which country? EEU-rules, TSD-methods (lengthy answer) EEU-rules, TSD-methods (lengthy question) n2 based on PK metric with higher CV Q&A ref The omniscient oracle has spoken The omniscient oracle has spoken OT: Булга́ков n2 based on PK metric with higher CV AUC passes with 0.05 and Cmax with 0.0294 AUC passes with 0.05 and Cmax with 0.0294 Hybrid B/C AUC passes with 0.05 and Cmax with 0.0294 Use data of all dosed subjects Use data of all dosed subjects ‘Method C’ ⇒ risky EEU-rules, TSD-methods (lengthy question) apple tree for two-stage overripe apples override apples	Two-Stage / GS Designs	Elena777	2019-09-09 19:34	24	2019-09-19 16:15	1,621
Snake Oil? Snake Oil? Snake Oil? Snake Oil?	Off Topic	Helmut	2019-09-09 15:48	3	2019-09-18 17:19	509
Input for CV when small first-in-man has been run Geometric mean and CV Geometric mean and CV Geometric mean and CV Geometric mean and CV Geometric mean and CV Geometric mean and CV Geometric mean and CV Geometric mean and CV Assumptions… Assumptions… Assumptions… Assumptions… t-test & Welch-test sampleN.TOST and CI.BE assumptions vs. realizations	Power / Sample Size	Rocco_M	2019-09-03 18:45	15	2019-09-18 11:04	1,285
predicting in vivo PK profiles from in vitro data after establishing IVIVC external predictability for ivivc external predictability for ivivc identical pH identical pH R scripts/codes for in-vivo conc. Software validation, another round Deconvolution Software validation, another round Software validation, another round Software validation, another round Should we also consider to validate the validation? Who inspects the inspectors? Who inspects the inspectors? Sapienti sat R scripts/codes for in-vivo conc. Bioavailabity term in predicted in-vivo conc.	Dissolution / BCS / IVIVC	amer	2019-09-09 05:04	16	2019-09-13 12:59	1,157
Evaluation of Heparin as a potentially interfering substance Evaluation of Heparin as a potentially interfering substance Evaluation of Heparin as a potentially interfering substance Evaluation of Heparin as a potentially interfering substance	Bioanalytics	Monic	2019-09-11 14:04	3	2019-09-11 21:25	574
2020 events listing 2020 events listing BioBridges 2020	Conferences / Workshops	Helmut	2019-09-10 13:33	2	2019-09-10 14:17	567
BA/BE for guidelines for ANVISA in English version ANVISA	Regulatives / Guidelines	Pandu	2019-09-10 05:30	1	2019-09-10 11:25	535