Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Baseline correction vs non-baseline correction Baseline correction vs non-baseline correction Baseline correction vs non-baseline correction Baseline correction or supra-therapeutic dose Baseline correction or supra-therapeutic dose Baseline profile prior to each period? Baseline correction examples Baseline correction examples Baseline correction examples Baseline correction examples Baseline correction examples Postmenopausal women Baseline correction examples Baseline correction examples Postmenopausal women Postmenopausal women Baseline correction examples Baseline correction GeoMean and Median Geometric mean? Geometric mean? Geometric mean ≈ MLE of median Geometric mean ≈ MLE of median Bias? Bias? Baseline; another example Baseline; another example Baseline; another example Baseline; another example Slowly going OT: BE study simulations Slowly going OT: BE study simulations Religious debate Religious debate Religious debate Religious debate Slowly going OT: BE study simulations Slowly going OT: BE study simulations Slowly going OT: BE study simulations Business as usual Business as usual	jag009	2015-09-15 20:29	38	2024-11-16 11:12	35,916
Shipment of Investigational Medicinal products Shipment of Investigational Medicinal products Shipment of Investigational Medicinal products	qualityassurance	2024-10-30 13:47	2	2024-11-06 14:15	2,645
FDA: Update of PSGs to align with ICH M13A FDA: ICH M13A, Q&A, PSGs, and a rant	Helmut	2024-10-03 15:58	1	2024-11-01 08:58	3,221
"Dose or Strength to be Studied" in ICH M13A "Dose or Strength to be Studied" in ICH M13A "Dose or Strength to be Studied" in ICH M13A	Darborn	2024-09-30 01:14	2	2024-10-08 00:58	2,713
Draft guideline on quality and equivalence of topical products – still stuck? Patience… MWP Final & published	mittyri	2024-09-14 20:24	3	2024-10-03 11:44	3,006
ICH M13 Guidance and Health Canada ICH M13A/C and Health Canada	AB661	2024-10-01 05:09	1	2024-10-01 06:29	2,477
Pooling of studies? coverage probability M13 M13 Q&A	Helmut	2024-09-02 13:55	3	2024-09-06 08:31	3,596
Cholestyramine and colesevelam in Vitro binding studies	jansari	2024-09-02 17:25	0		1,407
Acute and Sub-acute toxicity studies for FDA ANDAs Acute and Sub-acute toxicity studies for FDA ANDAs Acute and Sub-acute toxicity studies for FDA ANDAs	Achievwin	2024-08-05 18:50	2	2024-08-27 02:42	2,754
EU Reference Medicinal Product – Flexible or Absolute? EEA Reference Medicinal Product: Mandatory	PE	2024-08-20 10:39	1	2024-08-20 12:17	2,501
Predose concentration more than 5 % of Cmax FDC or isomers: C0 > 5 % of Cmax FDC or isomers: C0 > 5 % of Cmax Carryover. A Never Ending Story. Inducers/inhibitors Inducers/inhibitors Predose concentration more than 5 % of Cmax	NK	2024-08-05 06:07	6	2024-08-09 08:26	3,734
FDC with ascorbic acid FDC with ascorbic acid FDC with ascorbic acid Placebo? Placebo? 🇦🇹 AGES Placebo? Sorry – wrong addressee lucky	qualityassurance	2024-07-23 08:08	8	2024-07-24 16:01	4,057
Brazil, Mexico: Proc GLM or Proc Mixed? Brazil, Mexico: Proc GLM? Mexico: new guideline Mexico: ABEL Mexico: ABEL Mexico: ABEL Mexico: ABEL	jag009	2024-07-17 20:29	6	2024-07-23 19:43	4,045
full replicate study for drug not highly variable - EMA perspective EMA: Full replicate study	Ankit Parikh	2024-07-11 04:40	1	2024-07-15 09:13	2,979
Need some clarity on eCTD module 5	jag009	2024-07-12 16:04	0		1,795