Co-dosed compounds stability effect [Regulatives / Guidelines]
This deficiency was not addressed to my lab, therefore the only portion I have is what I posted. I do agree it looks very much like an FDA deficiency due to the font and layout.
This would be regarding BE studies, and we have been requested by some sponsors to evaluate this for inert molecules with no interconversion risk, such as ethinyl estradiol codosed with norgestrel. As a scientist I question the usefulness, while reducing the efficiency of the validation process. I understand evaluating stability in plasma having different types of anticoagulant, but this is going far beyond this.
However, I may be biased, therefore still looking for any good explanations.
This would be regarding BE studies, and we have been requested by some sponsors to evaluate this for inert molecules with no interconversion risk, such as ethinyl estradiol codosed with norgestrel. As a scientist I question the usefulness, while reducing the efficiency of the validation process. I understand evaluating stability in plasma having different types of anticoagulant, but this is going far beyond this.
However, I may be biased, therefore still looking for any good explanations.
Complete thread:
- Co-dosed compounds stability effect jchapdelaine 2010-05-10 17:03
- Co-dosed compounds stability effect Debbie 2010-05-11 17:13
- Co-dosed compounds stability effect Dr_Dan 2010-05-12 08:53
- Co-dosed compounds stability effect Ohlbe 2010-05-12 10:13
- Co-dosed compounds stability effectjchapdelaine 2010-05-12 19:40
- Co-dosed compounds stability effect Ohlbe 2010-05-12 10:13
- Co-dosed compounds stability effect Dr_Dan 2010-05-12 08:53
- Co-dosed compounds stability effect moblak 2010-11-17 15:53
- Co-dosed compounds stability effect jchapdelaine 2010-11-17 19:54
- Co-dosed compounds stability effect + drugs and metabolites moblak 2010-11-18 10:37
- Glucuronides Helmut 2010-11-18 15:49
- Co-dosed compounds stability effect + drugs and metabolites jchapdelaine 2010-11-19 20:36
- Co-dosed compounds stability effect + drugs and metabolites moblak 2010-11-18 10:37
- Co-dosed compounds stability effect jchapdelaine 2010-11-17 19:54
- Co-dosed compounds stability effect Debbie 2010-05-11 17:13
