Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Erythromycin Ethylsuccinate Tablet Erythromycin Ethylsuccinate Tablet	AB661	2025-04-02 11:39	1	2025-04-10 05:19	756
BE Study for Emedastine Fumarate 2 mg SR Capsules	Sunil	2025-04-08 09:29	0		498
ICH M13A complex study designs missing data and data excluded ICH M13A: Two-at-a-Time ICH M13A: Two-at-a-Time ICH M13A: Descriptive statistics ICH M13A: Descriptive statistics	kimhuang	2025-03-04 08:12	4	2025-03-08 05:55	1,603
2-period full replicate design for IR formulation – EMA perspective 2-period full replicate design for IR formulation – EMA perspective	Ankit Parikh	2024-07-11 04:58	1	2025-03-01 12:33	1,879
Product Labelling Query Product Labelling Query	professionalr	2025-02-18 22:01	1	2025-02-18 23:38	820
Conducting PK study in Mexico	jag009	2025-01-28 20:13	0		1,048
European Economic Area: ICH M13A effective with 25 January 2025	Helmut	2025-01-28 10:49	0		736
Compensation to patient Compensation to patient Compensation to patient	Pharma_88	2025-01-22 13:02	2	2025-01-24 04:39	1,212
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	1,212
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	1,695
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	5,359
Clinical strategy for generic of biosimilar	qualityassurance	2025-01-09 08:41	0		874
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	2,552
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	26,181
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	1,650