Buch, Englisch, 96 Seiten, Format (B × H): 140 mm x 216 mm, Gewicht: 135 g
Buch, Englisch, 96 Seiten, Format (B × H): 140 mm x 216 mm, Gewicht: 135 g
ISBN: 978-0-8247-0115-4
Verlag: CRC Press
Describes 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.
Zielgruppe
Undergraduate
Autoren/Hrsg.
Weitere Infos & Material
Method development, optimization and validation approaches; method validation (USP/ICH); system suitability; method validation protocol; method transfer and revalidation.