Bioequivalence and Bioavailability Forum

WHO Guidelines draft, April 2014 wien-ui 2014-06-11 18:32
- WHO Guidelines draft, April 2014 wien-ui 2014-06-14 09:44
  - Two-Stage Designs Helmut 2014-06-16 13:14
    - interim analysis, wording ElMaestro 2014-06-16 13:41
      - interim analysis, wording Helmut 2014-06-16 14:11
- WHO Guidelines draft, April 2014 wien-ui 2014-06-18 20:45
  - No Add-on studies Helmut 2014-06-22 14:31

Smoking in bioequivalence studies Ghannam86 2014-06-21 01:05
- Smoking in bioequivalence studies Helmut 2014-06-21 12:56
  - Smoking in bioequivalence studies Ghannam86 2014-06-22 00:04
    - More information, please Helmut 2014-06-22 00:22

Health Canada spcs search bharathnadh.pharma 2014-06-16 13:28
- Health Canada Helmut 2014-06-16 14:58
  - Health Canada bharathnadh.pharma 2014-06-21 09:38

Archival period for Investgational products pravin17 2014-06-20 14:15

three consecutive missing samples Mahesh M 2014-06-18 09:47
- three consecutive missing samples jag009 2014-06-18 16:05

Draft guidance for industry, entitled ANDA Submissions suchit_bhavsar 2014-06-13 08:20

Justification of AUC0-72 usage and AP calculation mittyri 2014-06-10 20:05
- EMA: No justification needed Helmut 2014-06-10 21:17

Two Reference Products with different Indications prashantmohite 2014-06-06 07:15
- Two Reference Products with different Indications ElMaestro 2014-06-06 11:37

acceptance criteria for tacrolimus Mahesh M 2014-06-03 08:46
- acceptance criteria for tacrolimus Ohlbe 2014-06-03 10:04

Cyclosporine sample size and design for BE study kardambhatt 2014-05-30 08:15

Guideline for bioequivalence Zimbabwe HV 2014-05-28 19:45

Selection of samples for Incurred Sample Reanalysis Ken Peh 2014-05-22 19:42
- Selection of samples for Incurred Sample Reanalysis Helmut 2014-05-23 13:12
  - Selection of samples for Incurred Sample Reanalysis Ohlbe 2014-05-24 20:16
    - Selection of samples for Incurred Sample Reanalysis Ken Peh 2014-05-28 13:56
      - Selection of samples for Incurred Sample Reanalysis Ohlbe 2014-05-28 14:27

Veterinary bioequivalence Tina 2014-04-24 10:23
- Veterinary bioequivalence SDavis 2014-05-20 14:00
- Veterinary bioequivalence SDavis 2014-05-21 23:07
  - Veterinary bioequivalence-VICH GL52 Tina 2014-05-22 11:55
    - Veterinary bioequivalence-VICH GL52 Helmut 2014-05-22 13:19

Restriction Compliances Irukulla Shravan Kumar 2014-04-24 07:31
- Restriction Compliances Dr_Dan 2014-04-24 09:30
  - Restriction Compliances krish 2014-05-03 13:30
    - Restriction Compliances SDavis 2014-05-20 14:23

FDA’s Draft guidance on Demonstration of Biosimilarity drgunasakaran1 2014-05-15 04:13
- FDA’s Draft guidance on Demonstration of Biosimilarity ElMaestro 2014-05-15 10:44
  - FDA’s Draft guidance on Demonstration of Biosimilarity drgunasakaran1 2014-05-18 17:34

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