Methods for Stability Testing of Pharmaceuticals /

Detalles Bibliográficos
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Bajaj, Sanjay. (Editor ), Singh, Saranjit. (Editor )
Formato: eBook
Lenguaje:English
Publicado: New York, NY : Springer New York : Imprint: Humana, 2018.
Edición:1st ed. 2018.
Colección:Methods in Pharmacology and Toxicology,
Materias:
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024 7 |a 10.1007/978-1-4939-7686-7  |2 doi 
040 |a Sistema de Bibliotecas del Tecnológico de Costa Rica 
245 1 0 |a Methods for Stability Testing of Pharmaceuticals /  |c edited by Sanjay Bajaj, Saranjit Singh. 
250 |a 1st ed. 2018. 
260 # # |a New York, NY :  |b Springer New York :  |b Imprint: Humana,  |c 2018. 
300 |a XIV, 358 p. 93 illus., 42 illus. in color. :  |b online resource. 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
490 1 |a Methods in Pharmacology and Toxicology, 
505 0 |a Regulatory Guidelines on Stability Testing and Trending of Requirements -- The Stability Dossier: Common Deficiencies and Ways to Improve -- In Silico Drug Degradation Prediction -- Forced Degradation and Long-Term Stability Testing for Oral Drug Products: A Practical Approach -- A Model Approach for Developing Stability-Indicating Analytical Methods -- Protocols for Characterization of Degradation Products with Special Emphasis on Mutagenic Degradation Impurities -- Stability Studies: Facility and Systems -- User Requirements & Implementation of a Risk-Based, Compliant Stability Management System Based on the FDA New Guidance on DATA Integrity -- Stability Considerations in the Life Cycle of Generic Products -- Predictive Stability Testing Utilizing Accelerated Stability Assessment Program (ASAP) Studies -- Statistical Methods and Approaches to Avoid Stability Failures of Drug Product During Shelf-Life -- Estimation of Stability Based on Monitoring of Shipment and Storage -- Stability Testing Parameters and Issues for Nanotechnology-Based Drug Products -- Stability Testing Issues and Test Parameters for Herbal Medicinal Products -- Stability Testing Considerations for Biologicals and Biotechnology Products. 
650 0 |a Pharmacology. 
650 1 4 |a Pharmacology/Toxicology. 
700 1 |a Bajaj, Sanjay.  |e editor. 
700 1 |a Singh, Saranjit.  |e editor. 
710 2 |a SpringerLink (Online service) 
773 0 |t Springer eBooks 
900 |a Libro descargado a ALEPH en bloque (proveniente de proveedor)