Compare Prices | Create Shopping Lists with Price Drop Alerts | Set Coupons, Promo Codes & Sales Alerts | Get Access to Exclusive Deals and Much More... All in One Place | Read all about it here

Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development

Brand
Springer Nature
Manufacturer
N/A
Part Number
0
GTIN
9780387856261
Condition
New
Product Description

A COMPREHENSIVE AND PRACTICAL GUIDE TO STABILITY TESTING IN PHARMACEUTICAL DEVELOPMENT Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval for commercialization. Assessing drug product stability and safety can be quite complicated, and stability profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality, and regulatory affairs. Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices is the first volume to cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices. Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies, educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners. Topics covered include: Latest regulations for stability testing, including cGMP requirements, ICH guidelines, and global guidances from WHO, ASEAN, EMRO, and other regions. Post-approval considerations and regulatory filing strategies to support a global supply chain. Methodologies, including development of a stability-indicating method, method validation, and transfer. This book also discusses physical stability, non-chromatographic methodologies, and spectroscopic applications. Setting specifications, monitoring impurities, and establishing shelf-life of pharmaceutical products. Data management, including stability reports, CMC, and discussion of out-of-specification (OOS) and out-of-trend (OOT). USP-NF testing in support of stability. Current industry best practices on stability operation, validation, and calibration of stability chambers including considerations for photo-stability testing. Discussion of matrixing and bracketing to support reduced stability testing. Overview of stability programs for biologics and drug-in-devices pharmaceutical products. This collective work was written by a group of prominent international experts, who have been directly responsible for instituting industry best practices and establishing the current stability guidelines.

Available Colors
Available Sizes
1 Offer Price Range: $169.00 - $169.00
BEST PRICE

Single Product Purchase

$169.00
@ Link.springer.com     BUY Now

Price Comparison

Seller Contact Seller List Price On Sale Shipping Best Promo Final Price Volume Discount Financing Availability Seller's Page
BEST PRICE
1 Product Purchase
@ Link.springer.com
Contact Store Call Store Contact Support
$169.00 $169.00

$169.00
See Site In stock Visit Store

Similar Products

Transfer, Diffusion and Adoption of Next-Generation Digital Technologies

$119.99

People (Jen), State and Inter-state Relations

$59.99

Structured Light Fields

$109.99

Arms Control and Europe

$129.99

Discriminative Pattern Discovery on Biological Networks

$54.99

Fifty Years After the "Homage to Santa Rosalia": Old and New Paradigms on Biodiversity in Aquatic Ec

$169.99

Guide to Signals and Patterns in Image Processing

$54.99

Lectures on Probability Theory and Statistics

$39.99

Die einfachen Kreislaufgren beim chirurgischen Patienten

$29.99

Planungs- und Bauablauf

$69.99

Viral Hepatitis: Chronic Hepatitis B

$39.99

Freie Durchforstung

$69.99

The Brauer-Hasse-Noether Theorem in Historical Perspective

$39.99

Qualittsmanagement

$69.99

The Economics of Water

$59.99

Geometric Modelling

$109.99

Diskurse des Climate Engineering

$59.99

Anleitung zu den Physiologischen bungen fr Studierende der Medizin

$59.99

The Economics of Multispecies Harvesting

$109.99

Liquid Separations with Membranes

$109.99

GIEE 2011: Gender and Interdisciplinary Education for Engineers

$49.99

Autonomous Systems and Intelligent Agents in Power System Control and Operation

$169.99

Honey and Me (Hardcover)

$13.49

Hydrological Aspects of Climate Change

$139.00

Karst Environments

$179.99

Ovulation Induction and Controlled Ovarian Stimulation

$119.99

Seismic Waves in Laterally Inhomogeneous Media

$49.95

Plant Mutagenesis

$189.00

Nanomedicines for the Prevention and Treatment of Infectious Diseases

$249.99

Survive and Thrive

$14.99

Novel Pharmacological Interventions for Alcoholism

$39.99

The Ethics of Artificial Intelligence for the Sustainable Development Goals

$129.99

Preparedness for Future Pandemics

$159.99

Soft and Hard Probes of QCD Topological Structures in Relativistic Heavy-Ion Collisions

$109.99

Evolutionary Multi-Criterion Optimization

$109.99

Mobilitt und Alltag

$39.99

The Semantic Web: ESWC 2023 Satellite Events

$74.99

Unconventional Computation and Natural Computation

$59.99

Duale Schriftnutzung: Brailleschrift und Schwarzschrift

$49.99

The Relationship between Land-lost Farmers and Local Government in China

$84.99