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Spections – Bioanalytical Part, Pharmacokinetic And Statistical Analyses Of Bioequivalence Trials (Nov.2017 – Under EU Clinical Trial Regulation 536/2014) FDA: • Guidance For Industry – Bioanalytical Method Validation (draft) September 2013– ICH: • Q2(R1): Validation Of Analytical Procedures: Text And Methodology Feb 4th, 2024
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