Bioequivalence and Bioavailability Forum

For Canada submission suchit_bhavsar 2011-04-04 10:23
- For Canada submission drgunasakaran1 2011-04-06 09:45
  - For Canada submission suchit_bhavsar 2011-04-08 09:29

Canadian reference product mvgchakravarthi 2011-04-05 17:26

Health Canada Submission: full replicate BE study allowed? luvblooms 2011-04-01 14:33
- Replicate design(s): why not? Helmut 2011-04-01 16:15
  - Replicate design(s): why not? luvblooms 2011-04-05 08:54
    - Replicate design(s): why not? ElMaestro 2011-04-05 10:05
      - Replicate design(s): why not? luvblooms 2011-04-05 13:58
    - No concentration after reference product Ohlbe 2011-04-05 10:30

Canada MR Paresh 2011-03-25 09:02
- Canada MR: MD if accumulation likely Helmut 2011-03-25 13:27
  - Canada MR: MD if accumulation likely Paresh 2011-03-26 10:08

Sub-investigators on 1572 form jlanteigne 2011-03-23 23:14
- Sub-investigators on 1572 form Ohlbe 2011-03-24 00:20
  - Sub-investigators on 1572 form and financial discosure jlanteigne 2011-03-24 15:34
    - Sub-investigators on 1572 form and financial discosure Ohlbe 2011-03-24 18:56
    - Sub-investigators on 1572 form and financial discosure aracine 2011-03-25 20:04

Guidance on MR oral and transdermal dosage forms rohitkachhadiya 2011-03-21 10:29
- MR fasting/fed Helmut 2011-03-21 13:34
  - MR fasting/fed rohitkachhadiya 2011-03-23 06:07
    - EU-MR: no food effect ⇒ fed study Helmut 2011-03-23 15:26
      - EU-MR: no food effect ⇒ fed study rohitkachhadiya 2011-03-24 05:27
        
        EU-MR: no food effect ⇒ fed study Helmut 2011-03-24 05:45
        
        DNFTT Jaime_R 2011-03-24 12:36

TGA: old or new EU GL? Paresh 2011-03-18 07:07
- TGA: new EU GL not adopted yet Helmut 2011-03-19 00:10
  - TGA: new EU GL not adopted yet Paresh 2011-03-21 11:22
    - TGA: BE on AUCt Helmut 2011-03-21 13:57

Retension Period sruman 2011-03-21 07:24
- Retension Period luvblooms 2011-03-21 10:49

one drug substance, 2 brands with different indications Shuanghe 2011-03-18 11:59
- one drug substance, 2 brands with different indications Jaime_R 2011-03-18 12:59
  - one drug substance, 2 brands with different indications Shuanghe 2011-03-18 16:04
    - one drug substance, 2 brands with different indications Helmut 2011-03-18 21:25
      - one drug substance, 2 brands with different indications Shuanghe 2011-03-21 10:10

ICH-GCP Informed Consent Procedure swapnil.kuche 2011-03-17 08:15
- ICH-GCP Informed Consent Procedure Ohlbe 2011-03-17 10:14

Need of chiral assay (EU) HV 2011-02-22 10:49
- Need of chiral assay (EU) Dr RCG 2011-03-09 05:11
  - BE of active, PK of inactive (EU) Helmut 2011-03-09 15:33

BE studies for NDAs Phaneendra.K 2011-03-09 09:03

Hospitalization of volunteers konkous 2011-03-01 21:08
- Hospitalization of volunteers manan 2011-03-03 07:24
  - Hospitalization of volunteers Helmut 2011-03-03 13:39
    - Hospitalization of volunteers manan 2011-03-05 07:29
      - Hospitalization of volunteers Helmut 2011-03-05 12:38

New EU Annex 11 jlanteigne 2011-03-03 21:03

Draft EMA Guideline on Drug Interactions vezz 2011-03-01 12:53

Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
385 visitors (0 registered, 385 guests [including 23 identified bots]).
Forum time: 05:45 CEST (Europe/Vienna)

Don’t compromise yourself.
You are all you’ve got. Janis Joplin

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz