Franklin

Methods for Stability Testing of Pharmaceuticals [electronic resource] / edited by Sanjay Bajaj, Saranjit Singh.

Publication:
New York, NY : Springer New York : Imprint: Humana Press, 2018.
Series:
Methods in pharmacology and toxicology 1557-2153
Methods in Pharmacology and Toxicology, 1557-2153
Format/Description:
Book
1 online resource (XIV, 358 pages) : 93 illustrations, 42 illustrations in color.
Subjects:
Medicine.
Pharmacology.
Local subjects:
Biomedicine.
Pharmacology/Toxicology.
System Details:
text file PDF
Summary:
This detailed volume collects numerous methods and protocols related to different aspects of stability programs that are followed in pharmaceutical development laboratories. Implementation of a successful stability program, vital in preventing product failures and recalls, requires critical and logical thinking that goes beyond the regular documented protocols and methods, so the experiences of the book's internationally-based expert contributors fill the chapters with practical guidance. As a volume in the Methods in Pharmacology and Toxicology series, this book presents the kind of real-world advice that is essential for advancing laboratory research.  Authoritative and thorough, Methods for Stability Testing of Pharmaceuticals serves as a valuable addition to the existing armamentarium of resources available to stability testing personnel in research and industry.
Contents:
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 and 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.
Contributor:
Bajāja, Sañjaya, editor.
Singh, Saranjit. editor.
SpringerLink (Online service)
Contained In:
Springer eBooks
Other format:
Printed edition:
ISBN:
9781493976867
Publisher Number:
10.1007/978-1-4939-7686-7 doi
Access Restriction:
Restricted for use by site license.
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