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BIOANALYTICAL METHOD VALIDATION –HOW, HOW MUCH AND WHY: A REASEACH PERSPECTIVE. Ankit Kumar Yadav, Sachin Kumar Singh, Yashwant, Surajpal Verma

BIOANALYTICAL METHOD VALIDATION –HOW, HOW MUCH AND WHY: A REASEACH PERSPECTIVE.

Ankit Kumar Yadav, Sachin Kumar Singh, Yashwant, Surajpal Verma

International Journal of Natural Product Science 2012: Spl Issue 1:123.

Abstract(RBIP-123)

The main objective of bioanalytical method validation is to demonstrate the reliability of a particular method for the determination of an analyte concentration in a specific biological matrix, such as blood, plasma, urine, saliva or tissue. The reliability of analytical findings is a matter of great importance in forensic and clinical toxicology, as it is of course a prerequisite for correct interpretation of toxicological findings. Unreliable results might not only be contested in court, but could also lead to unjustified legal consequences for the defendant or to wrong treatment of the patient. The importance of validation, at least of routine analytical methods, can therefore hardly be overestimated. This is especially true in the context of quality management and accreditation, which have become matters of increasing importance in analytical toxicology in recent years. This is also reflected in the increasing requirements of peer reviewed scientific journals concerning method validation. Therefore, this topic should extensively be discussed on an international level to reach a consensus on the extent of validation experiments and on acceptance criteria for validation parameters of bioanalytical methods in forensic (and clinical) toxicology.
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