Bioequivalence and Bioavailability Forum

BLQ considerations Loky do 2022-03-28 12:16
- BLQ considerations dshah 2022-03-28 14:14
- ‘Embedded’ BQLs Helmut 2022-03-28 14:32

Analytical range LOQ Farmacevt 2021-12-20 20:54
- Analytical range LOQ ElMaestro 2021-12-20 22:46
  - Analytical range LOQ Farmacevt 2021-12-22 22:02
- Analytical range LOQ dshah 2021-12-21 12:03
- LLOQ based on ‘worst case’ Cmax Helmut 2021-12-21 13:31
  - LLOQ based on ‘worst case’ Cmax ElMaestro 2021-12-21 15:48
    - LLOQ based on ‘worst case’ Cmax Helmut 2021-12-22 23:16

GLP certification for Bioanalytical Lab. to conduct BA/BE studies. Shreyas G 2021-12-17 21:22
- GLP certification for Bioanalytical Lab. to conduct BA/BE studies. ElMaestro 2021-12-18 08:55
  - GLP certification for Bioanalytical Lab. to conduct BA/BE studies. Shreyas G 2021-12-18 19:05

Manual integration Helmut 2021-12-01 13:09
- Manual integration ElMaestro 2021-12-01 14:40
  - Manual integration Helmut 2021-12-01 17:38

Use of NP (Normal Phase) columns in bioanalysis selwa ts 2021-11-17 11:04
- Hydrophilic Interaction Liquid Chromatography Helmut 2021-11-17 11:43
  - Hydrophilic Interaction Liquid Chromatography selwa ts 2021-11-17 15:11

planning of bioequivalence sampling selwa ts 2021-10-31 10:13
- planning of bioequivalence sampling dshah 2021-11-01 10:34
- Challenge - something for the programmers here ElMaestro 2021-11-07 19:47
  - Really (really) tough stuff Helmut 2021-11-07 23:33

dead / void volume Bioanalytical 2021-10-03 16:28
- dead / void volume Helmut 2021-10-03 21:14

Suitability in bioanalysis selwa ts 2021-09-09 19:44
- Suitability in bioanalysis Ohlbe 2021-09-09 23:09

Mean IS Variability consideration for Endogenous molecule-Stripped Matrix or BSA ksreekanth 2021-04-22 09:37
- Mean IS Variability consideration for Endogenous molecule-Stripped Matrix or BSA dshah 2021-04-29 06:06

Bioanalysis monitoring by sponsor dshah 2021-03-02 16:19
- Bioanalysis monitoring by sponsor Ohlbe 2021-03-04 18:24
  - Bioanalysis monitoring by sponsor dshah 2021-03-06 04:32
    - Bioanalysis monitoring by sponsor Ohlbe 2021-03-08 23:12
      - Bioanalysis monitoring by sponsor dshah 2021-03-09 17:01

Different sampling time points and Blinding Pharma_88 2020-12-11 05:22
- Different sampling time points and Blinding Helmut 2020-12-11 10:38
  - Different sampling time points and Blinding ElMaestro 2020-12-11 11:07
    - Different sampling time points and Blinding Helmut 2020-12-11 17:44
      - Different sampling time points and Blinding ElMaestro 2020-12-11 21:57
        
        Blinding… Helmut 2020-12-12 12:06

Au sujet de la conservation du plasma frais congelé vierge Developper bioanalyste 2020-10-14 16:33
- Conservation du plasma frais congelé vierge - storage of blank plasma Ohlbe 2020-10-14 23:37
  - OT: Preferred language in the forum Helmut 2020-10-15 00:40
    - OT: Preferred language in the forum yjlee168 2020-10-15 01:50
      - OT: Preferred language in the forum Helmut 2020-10-15 11:37
    - OT: Preferred language in the forum ElMaestro 2020-10-15 08:19
      - OT: Preferred language in the forum Helmut 2020-10-15 12:02
    - Just to annoy Helmut jag009 2020-10-19 19:52
      - Easy, Fritz! Helmut 2020-10-19 20:42

An example of IS response. Need your helps. Shuanghe 2020-05-26 12:56
- An example of IS response. Need your helps. Sukalpa Biswas 2020-05-26 13:49
  - An example of IS response. Need your helps. Shuanghe 2020-05-26 16:32
  - An example of IS response. Need your helps. Ohlbe 2020-05-26 17:46
- An example of IS response. Need your helps. Ohlbe 2020-05-26 14:42
  - Placement of CC Helmut 2020-05-26 15:35
    - An example of IS response. Shuanghe 2020-05-26 16:32
      - An example of IS response. Ohlbe 2020-05-26 17:27
    - Placement of CC Ohlbe 2020-05-26 17:32
      - Placement of CC Helmut 2020-05-26 19:03
        
        Duplicate LLOQ and ULOQ Ohlbe 2020-05-26 19:43
        
        Duplicate LLOQ and ULOQ Helmut 2020-05-27 16:30
- An example of IS response. Need your helps. ElMaestro 2020-05-26 15:44
- An example of IS response. Need your helps. ksreekanth 2020-07-06 13:37
- Trend analysis as per recent USFDA guideline dshah 2020-08-01 07:32
  - Only for QCs; encouraged ≠ required Helmut 2020-08-01 14:13
    - Only for QCs; encouraged ≠ required dshah 2020-08-03 09:17
      - Deviation from the mean response Helmut 2020-08-07 13:28
    - Only for QCs; encouraged ≠ required Shuanghe 2020-08-03 13:56
      - Broken-stick regression Helmut 2020-08-04 18:04

dilution factor to be applied avinash 2020-08-06 06:30

Reanalysis for Pharmacokinetic Reason Obinoscopy 2020-07-16 14:30
- Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-16 15:10
  - Reanalysis for PK Reason: Gone with the Wind Ohlbe 2020-07-16 17:16
    - Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-16 18:39
      - Reanalysis for PK Reason: Gone with the Wind Ohlbe 2020-07-16 19:15
    - Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-16 21:48
      - PK assessors variability Ohlbe 2020-07-16 23:07
        
        Sometimes PK assessors ≈ scientists Helmut 2020-07-17 16:11
        PK assessors variability Obinoscopy 2020-07-17 23:48
      - Reanalysis for PK Reason: Gone with the Wind ElMaestro 2020-07-16 23:19
        
        Reanalysis for PK Reason: Gone with the Wind dshah 2020-07-17 06:40
        
        Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-18 00:27
        
        Reanalysis for PK Reason: Gone with the Wind dshah 2020-07-20 07:22
        
        Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-20 14:12
        Positive pre-dose Ohlbe 2020-07-20 14:43
        
        Reanalysis for PK Reason: Gone with the Wind Obinoscopy 2020-07-18 00:00
        
        Reanalysis for PK Reason: Gone with the Wind ElMaestro 2020-07-20 07:49
        
        Reanalysis for PK Reason: Gone with the Wind Helmut 2020-07-20 10:52
        
        Sightly OT (for once) ElMaestro 2020-07-20 12:12
- Reanalysis for Pharmacokinetic Reason Achievwin 2020-07-27 23:47