Bioequivalence and Bioavailability Forum

Acceptance criteria of analytical run qualityassurance 2021-10-18 07:00
- Acceptance criteria of analytical run ElMaestro 2021-10-18 08:35
- Acceptance criteria of analytical run dshah 2021-10-18 12:36
  - Acceptance criteria of analytical run qualityassurance 2021-10-19 15:25
    - Acceptance criteria of analytical run Ohlbe 2021-10-19 18:54
      - Acceptance criteria of analytical run qualityassurance 2021-10-21 16:51
- Acceptance criteria of analytical run Ohlbe 2021-10-18 14:43
  - ’Percentage’ of few values Helmut 2021-10-20 14:06
    - ’Percentage’ of few values qualityassurance 2021-10-21 16:57

Ibuprofen product-specific bioequivalence guidance EMA qualityassurance 2021-09-26 07:45
- Ibuprofen product-specific bioequivalence guidance EMA dshah 2021-09-27 10:22
- Undeliverable e-mail Helmut 2021-09-27 14:52
- Enantioselective assay – really? Helmut 2021-09-27 15:55
  - Enantioselective assay – really? qualityassurance 2021-10-12 15:15

Sevelamer Carbonate In vitro binding study for EMA submission jansari 2021-09-24 19:03

dropouts in replicate studies Loky do 2021-09-23 14:54
- dropouts in replicate studies dshah 2021-09-23 19:28
- The EMA’s ‘Data set I’ is incomplete Helmut 2021-09-24 11:36
  - The EMA’s ‘Data set I’ is incomplete Loky do 2021-09-25 22:01

RLD identification in EU region in view of Brexit shahajan baig 2021-08-31 14:49
- RLD identification in EU region in view of Brexit dshah 2021-08-31 16:40
  - MHRA: No ‘own’ BE GL? Helmut 2021-09-24 15:36
- RLD identification in EU region in view of Brexit Ohlbe 2021-09-09 22:55
  - RLD identification in EU region in view of Brexit shahajan baig 2021-09-10 16:44
    - No ‘RLD’ in the EEA Helmut 2021-09-10 20:22

Desperate reader Helmut 2021-08-27 15:51
- Desperate reader ElMaestro 2021-08-27 22:18
  - Misunderstanding? Helmut 2021-08-27 23:54
    - Misunderstanding? ElMaestro 2021-08-28 10:00
      - Here we are Helmut 2021-08-28 10:38
- Papers Mahmoud 2021-09-17 13:31
  - FDA: PROC MIXED (‼) for ABE Helmut 2021-09-17 15:15
    - FDA: PROC MIXED (‼) for ABE Mahmoud 2021-09-17 15:24
      - FDA: PROC MIXED (‼) for ABE Helmut 2021-09-17 17:11

Clarity required suchit_bhavsar 2021-08-27 05:02
- Follow the guidance Helmut 2021-08-27 10:31

Bootstrapping methodology in Bioequivalence Achievwin 2021-08-17 22:30

“Fixed Effects, Rather Than Random Effects…” ElMaestro 2021-08-04 08:18
- Very nice! Helmut 2021-08-04 10:16
  - Very nice! ElMaestro 2021-08-04 12:51
    - Narrower CI with LM? Helmut 2021-08-04 15:22

What would be the study design for gliclazide 80mg tablet for Europe, WHO & HKG prasad.v 2021-07-29 10:33
- No acceptance criteria widening for AUC in Europe vixen 2021-07-30 18:44
- No reference-scaling for NTIDs Helmut 2021-08-02 14:57
- What would be the study design for gliclazide 80mg tablet for Europe, WHO & HKG drgunasakaran1 2021-08-06 08:47

statistical approaches for dose-finding PK studies Sridhar.E 2021-07-13 11:04
- statistical approaches for dose-finding PK studies msmnainar 2021-07-17 19:04

Bracketing approach for multiple strenght product EMA jag009 2021-07-06 19:19
- Bracketing approach for multiple strenght product EMA dshah 2021-07-17 11:44

End study requirements for Brazil submission khageswara Rao 2021-07-01 08:43
- End study requirements for Brazil submission drgunasakaran1 2021-07-05 10:15

Ethnicity of Indian population Vishal S 2021-06-22 07:25
- Ethnicity of Indian population drgunasakaran1 2021-06-24 06:06
  - Ethnicity of Indian population VijithRoy 2021-06-30 06:43
- Ethnicity of Indian population Achievwin 2021-07-06 16:21

Number of sets selection in In-Vitro Kinetic and Equilibrium Binding study Sivakrishna 2021-06-10 08:12

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