While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages.
Highlights from Liquid Products, Volume Three include:
Le informazioni nella sezione "Riassunto" possono far riferimento a edizioni diverse di questo titolo.
REGULATORY AND MANUFACTURING GUIDANCE
Manufacturing Practice Considerations in Liquid Formulations
Oral Solutions and Suspensions
The FDA Drug Product Surveillance Program
Changes to Approved NDAs and ANDAs
Formulation Considerations of Liquid Products
Container Closure Systems
Material for Containers
Stability Testing of New Drug Substances and Products
Stability Testing: Photostability Testing of New Drug Substances and Products
Stability Testing for New Dosage Forms
Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Evaluation of Stability Data
Stability Data Package for Registration Applications in Climatic Zones III and IV
EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use
EDQM Certification
Impurities: Guideline for Residual Solvents
Electronic Records and Signatures (CFR 21 Part 11 Compliance)
GMP Audit Template, EU Guidelines
Bioequivalence Testing Protocols
Dissolution Testing of Liquid Dosage Forms
Approved Excipients in Liquid Forms
MANUFACTURING FORMULATIONS
Manufacturing Formulations
Le informazioni nella sezione "Su questo libro" possono far riferimento a edizioni diverse di questo titolo.
Spese di spedizione:
GRATIS
In U.S.A.
Descrizione libro Condizione: Brand New. New.SoftCover International edition. Different ISBN and Cover image but contents are same as US edition. Expediting shipping for all USA and Europe orders excluding PO Box. Excellent Customer Service. Codice articolo ABEOCT23-128624