International Pharmaceutical Product Registration

Drugs and the Pharmaceutical Sciences

Book 200
1
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Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.

The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.

This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed.

The book is organized into six highly practical segments:

  • Part I: CTD, eCTD, Module 1, and Environmental Risk Assessment
  • Part II: CTD Summaries
  • Part III: Quality Topics
  • Part IV: Nonclinical Topics
  • Part V: Clinical Topics
  • Part VI: Other Topics (including drug-device combination products)

This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan.

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Additional Information

Publisher
CRC Press
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Published on
Apr 19, 2016
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Pages
852
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ISBN
9781420081831
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Best For
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Language
English
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Genres
Medical / Pharmacology
Medical / Research
Technology & Engineering / Chemical & Biochemical
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Content Protection
This content is DRM protected.
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Eligible for Family Library

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Employing a wide range of examples from G-protein-coupled receptors and ligand-gated ion channels, this detailed, single-source reference illustrates the principles of pharmacological analysis and receptor classification that are the basis of rational drug design.
Explains the experimental and theoretical methods used to characterize interactions between ligands and receptors-providing the pharmacological information needed to solve treatment problems and facilitate the drug design process!
Demonstrating the achievements of the receptor-based approach in therapeutics and indicating future directions, Receptor-Based Drug Design
introduces novel computer-assisted strategies for the design of new agonists, antagonists, and inverse agonists for G-protein-coupled receptors
shows how to assess agonist concentration-effect curve data
discusses radioligand binding assays
presents new in vitro multiarray assays for G-protein-coupled receptors
explains the use of individual second messenger signaling responses in analyzing drug-receptor interactions
examines the role of electrophysiology in finding new drugs and drug targets
describes selectively acting b-adrenoceptor agonists and glucocorticoid steroids for asthma treatment
outlines the rationale for using angiotensin receptor antagonists
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Written by over 25 international authorities and containing nearly 1200 bibliographic citations, Receptor-Based Drug Design is a practical resource for pharmacologists, pharmacists, and pharmaceutical scientists; organic and medicinal chemists and biochemists; molecular biologists; biomedical researchers; and upper-level undergraduate and graduate students in these disciplines.
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