ABSTRACT
Analytical methods are measurement systems that are used to determine the identity, strength, quality, purity, and potency of the drug substance and drug product. As such, they are an integral part of drug research and development, allowing for process understanding and conformance to quality standards. Many key decisions in biopharmaceutical development and manufacturing are made based on results from analytical methods. In early drug discovery, analytical results concerning the properties of candidate drugs are used to guide the selection of the lead drug candidates. In both preclinical and clinical development, analytical methods aid optimal dose selection and assess study endpoints. Analytical methods are also widely used in formulation and process development and optimization, and in quality control of marketed products. Since the quality of analytical methods has a direct and significant impact on successful development of a new drug, analytical methods must be developed and validated for their intended use.
