Bioequivalence and Bioavailability Forum

EU: Fed or fasting conditions for BE study Farmacevt 2021-09-24 15:47
- EU: Fed state according to the reference’s SmPC Helmut 2021-09-24 16:07
  - EU: Fed state according to the reference’s SmPC Farmacevt 2021-09-27 21:44

Application of AI/Machine learning for BA/BE studies Achievwin 2021-08-17 19:31
- Suffering from Human Unintelligence Helmut 2021-08-27 18:47
  - Suffering from Human Unintelligence Achievwin 2021-08-31 19:44
- Application of AI/Machine learning for BA/BE studies PharmCat 2021-09-02 20:23

HVD Pilot: 3 candidates, 1 reference Shah 2021-07-16 13:40
- HVD Pilot: 3 candidates, 1 reference ElMaestro 2021-07-16 13:51
  - HVD Pilot: 3 candidates, 1 reference lukamar 2021-07-20 08:54
    - HVD Pilot: 3 candidates, 1 reference ElMaestro 2021-07-20 09:31

Intrauterine Device – Levonorgestrel 52 mg marianna.macera 2021-06-30 15:04
- Intrauterine Device – Levonorgestrel 52 mg Relaxation 2021-06-30 17:22
  - Intrauterine Device – Levonorgestrel 52 mg marianna.macera 2021-07-02 16:55
    - Intrauterine Device – Levonorgestrel 52 mg Helmut 2021-07-02 17:18

Food effects prasad.v 2021-06-08 08:35
- Food effects drgunasakaran1 2021-06-09 06:06

bioequivalence if test and reference formulation having different strengths Vishal S 2021-05-24 09:21
- least common multiple of T and R Helmut 2021-05-24 12:32
  - least common multiple of T and R Vishal S 2021-05-25 13:26
    - least common multiple of T and R drgunasakaran1 2021-05-25 14:22
    - least common multiple of T and R Helmut 2021-05-26 00:23

Two-stage replicate design studies for RSABE Achievwin 2021-05-14 19:20
- Two-stage design ❎ RSABE Helmut 2021-05-14 20:14
  - Two-stage design ❎ RSABE Achievwin 2021-05-19 19:08
    - Two-stage design & RSABE: Forget it! Helmut 2021-05-19 20:40

Biowaiver for Emusion Dosage Form surajpatel 2021-05-11 10:27
- Biowaiver for Emusion Dosage Form drgunasakaran1 2021-05-12 07:52

Exclusion due to adverse event Loky do 2021-03-29 15:59
- State it in the SAP & observe it Helmut 2021-03-29 18:08
- Exclusion due to adverse event dshah 2021-03-31 14:43

BE study designing related doubts gsrao2022 2021-03-28 20:12
- BE study designing related doubts Helmut 2021-03-29 00:41

Question raised by the PMDA Helmut 2021-02-26 15:46
- Question raised by the PMDA Ben 2021-03-19 15:47
  - Question raised by the PMDA Helmut 2021-03-19 18:06

Obeticholic Acid Study Researcher101 2021-02-23 20:35

Bioequivalence of mirabegron 50 mg extended release Tablet Ibrahim Komeil 2021-02-20 11:36
- Replicate designs based on information of 2×2×2 design Helmut 2021-02-20 14:50
  - Replicate designs based on information of 2×2×2 design Ibrahim Komeil 2021-02-20 18:34
    - Assumption of authority 😉 Helmut 2021-02-20 20:50

RLD strength for BE study Brus 2021-01-21 14:24
- 505(j) = ANDA, 505(b)(2) NDA = ‘hybrid’ Helmut 2021-01-21 14:37
  - 505(j) = ANDA, 505(b)(2) NDA = ‘hybrid’ Brus 2021-01-25 16:56
    - Directive 2001/83/EC, Article 10(3) = hybrid Helmut 2021-01-25 17:39

partial AUCs for locally acting MR Susanh 2020-12-04 16:14
- partial AUCs for locally acting MR jag009 2020-12-05 08:01
  - partial AUCs for locally acting MR Kumarnaidu2 2021-05-28 11:55
    - partial AUCs for locally acting MR dshah 2021-05-31 08:47

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