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Validation
PUBLISHED
- All(35)
- References(0)
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Viewing: 1 - 10 of 35 |
Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as …
Hardback
$169.95
The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This thoroughly revised edition reflects the rapid changes in the field and includes:
New material on tableting scale-up and compaction.
Regulatory appendices that …
Hardback
$179.95
A major new work on all aspects of water, the most used raw material ingredient in the pharmaceutical and biotechnology industries—used as an excipient in pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent.
Drawing on the author’s extensive field …
Hardback
$259.95
During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them …
Hardback
$152.95
This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by …
Hardback
$199.95
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many …
Hardback
$279.95
This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy …
Hardback
$199.95
This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting. Intended as a learn-by-example guide, Pharmaceutical and Medical Device Validation by Experimental Design demonstrates why …
Hardback
$179.95
Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. …
Hardback
$239.95
All too often, the words "computer validation" strike terror into the hearts of those new to the process and may even cause those familiar with it to tremble. Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing delineates GCP, GLP, and GMP regulatory requirements …
Hardback
$239.95
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Handbook of Analytical Validation
Pharmacogenomics of Alcohol and Drugs of Abuse
Basic Pharmacokinetics, Second Edition
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Journal of Biopharmaceutical Statistics
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