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RegisterHighly variable drug product [PK / PD]
Hi Dr_Dan,
Understood and totally agree. I was just curious on what basis one justifies the need for a full four way replicate design study. I just don't see it unless one has identified the issues based on 1) quality issue - variation observed from dissolution/content uniformity/etc etc 2) running a pilot test only 2x2 or full replicate study.
John
❝ Please keep in mind: HVD ≠ HVDP
❝ HVDPs are products in which the drug must not necessaribly be highly variable, but the product could be of poor pharmaceutical quality => high within-formulation variability!
Understood and totally agree. I was just curious on what basis one justifies the need for a full four way replicate design study. I just don't see it unless one has identified the issues based on 1) quality issue - variation observed from dissolution/content uniformity/etc etc 2) running a pilot test only 2x2 or full replicate study.
John
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 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 productjag009 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