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Compliance ★ India, 2013-09-10 12:13 (4277 d 11:36 ago) Posting: # 11467 Views: 4,310 |
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Dear All, We are working on Progesterone and I have query related to the approach applied by the CRO while validating the method. As per my understanding and methods from the various CRO, all have done the validation with stripped and un-stripped plasma for the endogenous molecule. However the CRO with whom we are dealing has validated the method by using female plasma and use only those plasma for the bulk spiking which has shown less or nil endogenous level of progesterone and done the validation as per routine practices/ process applied to routine molecule. Is this approach is acceptable? however during study we are going to collect 2-3 pre dose sample for the base line correction. The approach applied by the CRO is new for me and seeking your expert comment on this. Logically I am agree with their approach however only worried about how the regulatory take this. Regards, Compliance |
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sarada06884 ☆ India, 2013-10-18 10:19 (4239 d 13:31 ago) @ Compliance Posting: # 11689 Views: 3,378 |
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Dear Compliance, In my opinion the CRO you are dealing with, has followed the right approach by performing the validation with stripped and un-stripped plasma for dealing with the endogenous concentreations of progesterone. Stripping the plasma would remove the drug which is present endogenously. Further only those plasma lots which showed less or nil endogenous level of progesterone were selected for bulk spiking. As per USFDA's GL on BMV "This guidance provides general recommendations for bioanalytical method validation. The recommendations can be adjusted or modified depending on the specific type of analytical method used." Based on this statement, any approach is acceptable to the regulatory, provided this is scientifically sound. Regards P.S.Srinivas |
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Compliance ★ India, 2013-10-19 10:53 (4238 d 12:56 ago) @ sarada06884 Posting: # 11709 Views: 3,355 |
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Dear Mr. P.s. Srinivas, here the case is, CRO has not given any treatment to the plasma to remove endogenous level. they had treat the method as routine one by using normal lot of plasma with the less concentration of endogenous molecule. please go through my question again. regards, Compliance |
Ing. Helmut Schütz