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RegisterHighly variable drug product [PK / PD]
Dear Jag
My experience
For simple IR products
BCS class-1 and III: very less (~none, only shock we gor once was for BUSPIRONE where Intra subject CV was 38% and inter subject CV was 80%)
BCS class-II and IV: ~50% case (mainly beause of variable ingredient effects, manufacturing process, variable rate and extentof absorption etc etc)
For MR/ER/PR products
Variability was observed in ~50 percent case inter-subject variability was higher mainly because of he design of test product.
My experience
For simple IR products
BCS class-1 and III: very less (~none, only shock we gor once was for BUSPIRONE where Intra subject CV was 38% and inter subject CV was 80%)
BCS class-II and IV: ~50% case (mainly beause of variable ingredient effects, manufacturing process, variable rate and extentof absorption etc etc)
For MR/ER/PR products
Variability was observed in ~50 percent case inter-subject variability was higher mainly because of he design of test product.
—
~A happy Soul~
~A happy Soul~
Complete thread:
- Highly variable drug product jag009 2013-02-05 22:03
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Highly variable drug product drgunasakaran1 2013-02-06 08:31
- Highly variable drug product jag009 2013-02-06 15:14
- Highly variable drug product Dr_Dan 2013-02-06 12:10
- Highly variable drug product jag009 2013-02-06 15:26
- Highly variable drug productluvblooms 2013-02-06 12:27
- Highly variable drug product jag009 2013-02-06 15:28
- Highly variable drug product Dr_Dan 2013-02-07 11:00
- HVD ≠ HVDP Helmut 2013-02-07 13:22
- Highly variable drug product jag009 2013-02-07 15:22
- Highly variable drug product Dr_Dan 2013-02-07 11:00
- Highly variable drug product jag009 2013-02-06 15:28
- Highly variable drug product drgunasakaran1 2013-02-06 08:31
Ing. Helmut Schütz