Phase-I

How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -II)

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How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -II) Out Of Specification( OOS ) :-  The all test results which goes outside the specification or acceptance criteria established in Drug Dossiers, Drug Master files, Its official Pharmacopeias, Or the manufacturer comes Under Out of Specification( OOS ). We have seen in last …

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How to Investigate Out Of Specification(OOS) Test Results….???( USFDA Phase -I)

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How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -I) Out Of Specification(OOS) :-  The all test results which goes outside the specification or acceptance criteria established in Drug Dossiers, Drug Master files, Its official Pharmacopeias, Or the manufacturer comes Under Out of Specification(OOS).   What USFDA guideline says about Investigation of Out …

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