Buch, Englisch, 376 Seiten, Format (B × H): 226 mm x 286 mm, Gewicht: 1130 g
Semisolid Products
Buch, Englisch, 376 Seiten, Format (B × H): 226 mm x 286 mm, Gewicht: 1130 g
ISBN: 978-1-4200-8126-8
Verlag: Taylor & Francis Inc
Highlights from Semisolid Products, VolumeFour include:
coverage of over 350 formulations
valuable information on the difficult area of compliance
changes to approved new drug applications and abbreviated new drug applications
the evolving guidelines of ICH and when to conduct a regulatory review
Zielgruppe
Pharmaceutical manufacturers, and quality assurance and production personnel.
Autoren/Hrsg.
Fachgebiete
Weitere Infos & Material
REGULATORY ANDMANUFACTURING GUIDANCEWaiver of In Vivo Bioequivalence StudyQuality Risk ManagementPharmaceutical Quality SystemPharmaceutical DevelopmentPharmaceutical Development in CTDScale-Up and Postapproval Changes for Nonsterile Semisolid Dosage Forms: Manufacturing EquipmentGOOD Manufacturing Practice Guide for Active Pharmaceutical IngredientsValidation of Analytical ProceduresValidation of Analytical Procedures: MethodologyBioequivalence Testing of Topical DrugsGood Manufacturing Requirements for Active Pharmaceutical IngredientsFDA Active Pharmaceutical Ingredient Manufacturing Facility InspectionSpecifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical SubstancesSkin Irritation and Sensitization Testing of Generic Transdermal Drug ProductsImpurities in New Drug SubstancesImpurities in New Drug ProductsFormulation Factors in Semisolid Dosage FormsGMP Audit Template, EU GuidelinesDissolution Testing of Semisolid Dosage FormsApproved Excipients in Semisolid Dosage FormsMANUFACTURING FORMULATIONSRegulatory and Manufacturing Guidance