Bioequivalence and Bioavailability Forum

BE criteria of extended release and enteric coated formulation for Canada khageswara Rao 2021-12-13 11:07
- Do your homework first Helmut 2021-12-13 15:33
  - Do your homework first khageswara Rao 2021-12-17 11:19

Primary pharmacodynamic bioequivalence ceylan 2021-11-19 15:46
- Primary pharmacodynamic bioequivalence ElMaestro 2021-11-19 16:22
  - Primary pharmacodynamic bioequivalence ceylan 2021-11-20 23:14

Outliers - this one is for you, zizou ElMaestro 2021-10-31 08:01

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

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

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

“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

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

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

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