Analytical Methods for the Recently Approved Fda New Molecular Entities – A Review

Abstract

Analytical method development and validation for the analysis therapeutic components and associated substances play an important role in the discovery, development and manufacture of pharmaceuticals and natural medicinal compounds. Pharmaceutical and herbal products formulated with more than one drug, typically referred to as combination products, are intended to meet previously unmet patients need by combining the therapeutic effects of two or more drugs in a single dosage. The new chemical entities and combination products can present daunting challenges to the analytical chemist responsible for the development and validation of analytical methods. The official test methods that result from these processes are used by quality control laboratories to ensure the identity, purity, potency, and performance of drug products [1].Analytical method development and validation though often considered routine, too little attention is paid to them with regards for their potential to contribute to overall developmental time and cost efficiency. These method-related activities are interrelated. They are iterative, particularly during early drug development phases. Parts of each process may occur concurrently or be refined at various phases of drug development. Changes encountered during drug development may require modifications to existing analytical methods. These modifications may require additional validation or transfer activities. In this paper, the overview the

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