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RegisterHighly variable drug product [PK / PD]
Dear John
You have to distinguish between variability due to Drug Product (inactive ingredient effects, manufacturing effects) and variability due to Drug Substance (variable absorption rate, extent, low bioavailability, low aqueous solubility, acid lability and most important extensive pre-systemic metabolism). Therefore in this case it would be also interesting to compare the inter-subject variability. In general the development of the test product is more advanced and the variability due to Drug Product is less.
Kind regards
Dan
You have to distinguish between variability due to Drug Product (inactive ingredient effects, manufacturing effects) and variability due to Drug Substance (variable absorption rate, extent, low bioavailability, low aqueous solubility, acid lability and most important extensive pre-systemic metabolism). Therefore in this case it would be also interesting to compare the inter-subject variability. In general the development of the test product is more advanced and the variability due to Drug Product is less.
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
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 productDr_Dan 2013-02-06 12:10
- Highly variable drug product jag009 2013-02-06 15:26
- Highly variable drug product luvblooms 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