Regulations & Standards

PUBLISHED


Viewing: 1 - 10 of 65
Published:
December 27, 2012
Editor(s):
Sandeep Nema; John D. Ludwig
This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it 
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$259.95
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Published:
November 17, 2011
Author(s):
William J. Mead
Dietary Supplement GMP is a one-stop "how-to" road map to the final dietary supplement GMP regulations recently issued by the FDA covering the manufacture, packaging, and holding of dietary supplement products. The recent regulations, outlining broad goals, intentionally avoid specifics to allow 
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$159.95
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Published:
October 26, 2011
Author(s):
Susanne Prokscha
The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and 
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$149.95
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Published:
July 27, 2011
Editor(s):
Steven W. Baertschi; Karen M. Alsante; Robert A. Reed
The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The 
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$259.95
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Published:
February 02, 2011
Editor(s):
Michael Levin
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 
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$179.95
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Published:
December 21, 2010
Author(s):
William V. Collentro
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 
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$259.95
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Published:
November 08, 2010
Editor(s):
Catherine Prescott; Dame Julia Polak
Now that prohibitions against stem cell research are relaxing, it is time for the field to move forward with the advances that promise to eliminate so much human suffering. However, it would be naïve to ignore the fact that regenerative medicines pose a whole new set of challenges to an industry 
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$189.95
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Published:
August 26, 2010
Editor(s):
Sandeep Nema; John D. Ludwig
This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it 
  Hardback
$721.00
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Published:
March 25, 2010
Author(s):
Leon Shargel; Isadore Kanfer
Generic Drug Product Development: Specialty Dosage Forms explores the issues in providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. In addition, the book provides various scientific approaches and regulatory requirements for manufacturers to demonstrate 
  Hardback
$219.95
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Published:
March 25, 2010
Editor(s):
Isadore Kanfer; Leon Shargel
Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove 
  Hardback
$219.95
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