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Pharmaceutical Science & Regulation
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Because of many misconceptions, the biological drug manufacturing industry does not fully utilize disposable components, despite their wide availability. These misconceptions include concerns for the quality of materials, running costs, scalability, the level of automation possible, and the …
Hardback
$157.95
Fermentation Microbiology and Biotechnology, Third Edition explores and illustrates the diverse array of metabolic pathways employed for the production of primary and secondary metabolites as well as biopharmaceuticals. This updated and expanded edition addresses the whole spectrum of fermentation …
Hardback
$139.95
As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the …
Hardback
$167.95
With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA’s recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and …
Hardback
$89.95
Incidences of inflammatory airway diseases are on the rise across the world. Existing therapeutic options are ineffective, unsafe, and expensive, and severe cases are nonresponsive to conventional therapy. Therefore, it is imperative that research be undertaken to discover new treatment options. …
Hardback
$167.95
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 …
Hardback
$159.95
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 …
Hardback
$149.95
Completely revised and updated, this second edition of Pharmaceutical Dosage Forms and Drug Delivery elucidates the basic principles of pharmaceutics, dosage form design, and drug delivery. The authors integrate aspects of physical pharmacy, biopharmaceuticals, drug delivery, and biotechnology. The …
Hardback
$119.95
Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry. Written by an experienced industry professional, this practical book provides a …
Hardback
$139.95
Adaptive clinical trial designs, unlike traditional fixed clinical trial designs, enable modification of studies in response to the data generated in the course of the trial. This often results in studies that are substantially faster, more efficient, and more powerful. Recent developments in …
Hardback
$93.95
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