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Accelerated Predictive Stability (APS)
  • Language: en
  • Pages: 512

Accelerated Predictive Stability (APS)

Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides hig...

HPLC Method Development for Pharmaceuticals
  • Language: en
  • Pages: 532

HPLC Method Development for Pharmaceuticals

  • Type: Book
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  • Published: 2011-09-21
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  • Publisher: Elsevier

High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. ...

Leachables and Extractables Handbook
  • Language: en
  • Pages: 702

Leachables and Extractables Handbook

A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP) such as metered dose inhalers, dry powder inhalers, and nasal sprays pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize...

Pharmaceutical Industry Practices on Genotoxic Impurities
  • Language: en
  • Pages: 536

Pharmaceutical Industry Practices on Genotoxic Impurities

  • Type: Book
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  • Published: 2014-08-29
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  • Publisher: CRC Press

A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretati

Mass Spectrometry in Biology & Medicine
  • Language: en
  • Pages: 576

Mass Spectrometry in Biology & Medicine

Leading practitioners detail revolutionary new spectrometric techniques for the identification and covalent structural characterization of macromolecules, proteins, glycoconjugates, and nucleic acids. Based on the Fourth International Symposium on Mass Spectrometry in the Health and Life Sciences held in San Francisco in 1998, this invaluable book contains tested strategies for solving many significant biomedical research problems. The techniques use mass spectrometry, automated computer processing of spectral information, and gene, protein, and EST databases for genomic and proteomic correlations. Mass Spectrometry in Biology and Medicine offers a unique opportunity to explore and apply these new techniques of mass spectrometry that are revolutionizing the identification and structural characterization of proteins, carbohydrates, and nucleic acids.

Encyclopedia of Pharmaceutical Technology
  • Language: en
  • Pages: 880

Encyclopedia of Pharmaceutical Technology

  • Type: Book
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  • Published: 2013-07-01
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  • Publisher: CRC Press

Presenting authoritative and engaging articles on all aspects of drug development, dosage, manufacturing, and regulation, this Third Edition enables the pharmaceutical specialist and novice alike to keep abreast of developments in this rapidly evolving and highly competitive field. A dependable reference tool and constant companion for years to com

The Story of Qiu Ju
  • Language: en

The Story of Qiu Ju

  • Type: Book
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  • Published: Unknown
  • -
  • Publisher: Unknown

None

Directory of Graduate Research
  • Language: en
  • Pages: 1850

Directory of Graduate Research

  • Type: Book
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  • Published: 2001
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  • Publisher: Unknown

Faculties, publications and doctoral theses in departments or divisions of chemistry, chemical engineering, biochemistry and pharmaceutical and/or medicinal chemistry at universities in the United States and Canada.

Hong lou meng jie
  • Language: zh-CN
  • Pages: 30

Hong lou meng jie

  • Type: Book
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  • Published: 1979
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  • Publisher: Unknown

None

物理化学学报
  • Language: zh-CN
  • Pages: 608

物理化学学报

  • Type: Book
  • -
  • Published: 1994
  • -
  • Publisher: Unknown

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