Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Conducting PK study in Mexico	jag009	2025-01-28 20:13	0		3,126
European Economic Area: ICH M13A effective with 25 January 2025	Helmut	2025-01-28 10:49	0		2,994
Compensation to patient Compensation to patient Compensation to patient	Pharma_88	2025-01-22 13:02	2	2025-01-24 04:39	4,984
Issue with PBE Calculation when Stage = 1 Issue with PBE Calculation when Stage = 1 Issue with PBE Calculation when Stage = 1	weiguo2122	2025-01-13 20:19	2	2025-01-15 20:45	5,243
ANVISA Guidelines on Participant Involvement in Clinical Trials ANVISA Guidelines on Participant Involvement in Clinical Trials	Rajul9	2024-11-24 18:19	1	2025-01-13 13:13	4,704
Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE] Population BE [PBE]	jdfr	2024-12-05 16:34	12	2025-01-09 14:46	13,308
Clinical strategy for generic of biosimilar	qualityassurance	2025-01-09 08:41	0		2,948
ICHM13/High risk products ICHM13/High risk products ICHM13/High risk products ICHM13/High risk products ICHM13/High risk products ICHM13/High risk products Generic vs. hybrid	Mikkabel	2024-11-20 09:00	6	2024-11-22 13:17	7,067
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	44,662
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	4,639
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	5,202
"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	4,834
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	5,338
ICH M13 Guidance and Health Canada ICH M13A/C and Health Canada	AB661	2024-10-01 05:09	1	2024-10-01 06:29	4,239
Pooling of studies? coverage probability M13 M13 Q&A	Helmut	2024-09-02 13:55	3	2024-09-06 08:31	6,467