Bioequivalence and Bioavailability Forum

Paliperidone injection - waiver option msmnainar 2016-07-01 08:53
- Paliperidone injection - waiver option Helmut 2016-07-01 10:17
  - Paliperidone injection - waiver option nobody 2016-07-01 11:08
    - Dose ≠ strength Dr_Dan 2016-07-04 10:16

Warfarin Guidance jag009 2016-06-22 19:43
- Warfarin Guidance Helmut 2016-06-22 21:12
  - Warfarin Guidance jag009 2016-06-27 16:40

Iron Sucrose mmw 2016-06-23 08:06

Iron Content hari emmadi 2016-06-04 09:01
- Iron Content BE-proff 2016-06-04 09:38

Revision of WHO guidance for CROs Ohlbe 2015-05-27 14:42
- Revision of WHO guidance for CROs Ohlbe 2015-09-16 14:28
  - Published Ohlbe 2016-06-02 16:05

Partial AUC & Cmax in case of multiphasic modified release drug product maulik963 2016-05-31 08:09
- The x unveiled Helmut 2016-05-31 13:14
  - The x unveiled maulik963 2016-06-02 13:45
    - Biphasic: x=2 Helmut 2016-06-02 14:07

truncated design Mahesh M 2015-12-29 11:21
- FDA: AUC0–72 Helmut 2015-12-29 13:12
  - FDA: AUC0–72 Mahesh M 2015-12-29 13:51
    - FDA: crystal ball Helmut 2015-12-29 15:43
      - FDA: crystal ball Averroes 2016-05-27 00:01

ANVISA and replicate designs d_labes 2016-05-11 09:47
- ANVISA and replicate designs Mauricio Sampaio 2016-05-18 06:14
- ANVISA and replicate designs earlybird 2016-05-19 16:10
  - ANVISA = EMA’s ABEL! Helmut 2016-05-19 16:23
    - ANVISA = EMA’s ABEL! Lucas 2016-05-19 18:32
      - Method A, B (or C?) Helmut 2016-05-19 19:04
      - ANVISA = EMA’s ABEL! Mauricio Sampaio 2016-05-19 19:57
      - ANVISA = EMA’s ABEL? d_labes 2016-05-24 09:46

What if the References listed drug changed strength? jag009 2016-05-20 17:26
- What if the References listed drug changed strength? Mauricio Sampaio 2016-05-20 18:56
  - What if the References listed drug changed strength? jag009 2016-05-20 21:48
- What if the References listed drug changed strength? nobody 2016-05-20 19:04

Pharmacokinetic interaction study Mahesh M 2016-05-12 07:07
- FDCPs: generally BE (higher BA under certain conditions) Helmut 2016-05-12 13:15
  - FDCPs: generally BE (higher BA under certain conditions) nobody 2016-05-12 13:41
    - FDCPs: generally BE (higher BA under certain conditions) Mauricio Sampaio 2016-05-19 05:47
- Pharmacokinetic interaction study Dr_Dan 2016-05-19 10:05
  - Pharmacokinetic interaction study nobody 2016-05-20 09:40

ANVISA Requirement suchit_bhavsar 2016-04-28 08:37
- ANVISA Requirement felipeberlinski 2016-05-10 16:10
- ANVISA Requirement Mauricio Sampaio 2016-05-18 15:43

FDA: NTI drugs jag009 2016-05-15 22:26
- FDA: NTI drugs; switching condition Helmut 2016-05-16 14:15

should sprinkle BE study be in fasting condition only or also in fed? chloe 2016-04-27 04:44
- To fast or not to fast d_labes 2016-04-27 07:50
  - To fast or not to fast chloe 2016-04-27 08:59
- should sprinkle BE study be in fasting condition only or also in fed? jag009 2016-05-09 23:14

IRB krish 2016-05-06 08:16
- Subjects rights Ohlbe 2016-05-09 11:03
- Right to leave Helmut 2016-05-09 12:30

EU reference product - no originator available nobody 2016-04-27 09:22
- No EU originator available: bad luck Helmut 2016-04-27 11:38
  - No EU originator available: bad luck nobody 2016-04-27 12:01
- no originator = no generic Dr_Dan 2016-04-27 15:42
  - no originator = no generic nobody 2016-04-27 16:31

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