01013nam a22001937a 450000500170000000800410001702000180005804000070007604100080008308200180009110000210010924500490013026000260017930000250020536500510023052004850028165000360076670000170080220240401162232.0240321b           ||||| |||| 00| 0 eng d  a9781032501574  cAL  aeng  223a543bSWAA  aMichael E Swartz  aAnalytical method development and validation  aBoca RatonbCRCc2023  a92p.bPBc21.5x14cm.  2Generala7743b716.00d895.00e20%f15-02-2024  aDescribes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.  2ChemistryaAnalytical chemistry  aKrull, Ira S