Bioequivalence and Bioavailability Forum

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

Glucose Clamp Algorithm VijithRoy 2020-12-04 06:35

Orlistat EMA Pharma_88 2020-11-27 13:51

Regarding Steady state study in BE studies VijithRoy 2020-11-20 04:28

ursodiol 300 mg capsule Sridhar.E 2020-11-09 16:17

Promazine hydrochloride Pharmacokinetics pjs 2015-05-13 05:45
- Promazine hydrochloride Pharmacokinetics pjs 2015-05-13 11:51
  - Promazine hydrochloride Pharmacokinetics nobody 2015-05-13 12:41
    - Promazine hydrochloride Pharmacokinetics pjs 2015-05-14 10:45
      - Promazine hydrochloride Pharmacokinetics The Outlaw Torn 2015-05-14 11:52
        
        Promazine hydrochloride Pharmacokinetics nobody 2015-05-14 13:25
        
        Promazine hydrochloride Pharmacokinetics The Outlaw Torn 2015-05-14 13:52
        
        Promazine hydrochloride Pharmacokinetics nobody 2015-05-14 14:33
        
        Promazine hydrochloride Pharmacokinetics pjs 2015-05-14 16:20
        
        Promazine hydrochloride Pharmacokinetics qualityassurance 2020-11-05 08:34

Metformin Bioequivalence Study AB661 2020-08-19 09:22

multiple dose bioequivalence study Loky do 2020-08-09 11:50
- EMA MR: long half life → MD Helmut 2020-08-09 12:08
  - EMA MR: long half life → MD Loky do 2020-08-09 19:06
- multiple dose bioequivalence study wienui 2020-08-10 08:00

Difference between BABE study and clinical trials VijithRoy 2020-07-30 15:15
- Difference between BABE study and clinical trials Obinoscopy 2020-07-30 16:31
- BABE ∈ Phase I Helmut 2020-07-30 16:35
- Difference between BABE study and clinical trials dshah 2020-07-31 10:46
  - Difference between BABE study and clinical trials VijithRoy 2020-07-31 13:52

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