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Drug Products for Clinical Trials, Second Edition (Drugs and the Pharmaceutical Sciences) [Hardcover]

Donald Monkhouse (Editor), Charles F. Carney (Editor), Jim Clark (Editor), Peter Brun (Editor)

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Book Description

ISBN-10: 082475462X | ISBN-13: 978-0824754624 | Publication Date: November 9, 2006 | Edition: 2

Addressing issues at the forefront of interest for the Clinical Trial Materials Professional (CTMP), this Second Edition highlights the most critical concepts related to the planning, manufacturing, packaging, labeling, distribution, reconciliation, and quality and regulatory control of clinical trial materials. It offers authoritative chapters by esteemed researchers and consultants in industry on the current and evolving state of clinical supplies operations. Tracking emerging trends and the development of new technologies, this Second Edition helps the CTMP operate effectively in the international sphere and reviews regulatory processes for drug approvals in the United States and Europe.

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Product Details

Hardcover: 399 pages
Publisher: Taylor & Francis; 2 edition (November 9, 2006)
Language: English
ISBN-10: 082475462X
ISBN-13: 978-0824754624
Product Dimensions: 9 x 6.2 x 1 inches
Shipping Weight: 2.1 pounds (View shipping rates and policies)
Amazon Best Sellers Rank: #715,319 in Books (See Top 100 in Books)

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Inside This Book (learn more)

First Sentence:
Today's sophisticated pharmaceutical technologies are changing rapidly as companies enhance older processes and explore innovative alternatives. Read the first page

Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
comparator medication, potent compound facility, clinical supplies operations, inhalation delivery systems, investigational supplies, global development team, placebo powder, hard gelatine capsules, medication kits, intake styles, medication cards, blister strips, clinical trial materials, inhalation products, weighing cell, comparative dissolution, clinical trial supplies, new excipients, lid stock, retest date, pulsatile delivery, packaging record, capsule body, investigational products, foreign inspections

Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, Alpha Tablets, European Union, Pharm Sci, Drug Discov Dev, Galaxy Pharmaceuticals, New York, European Commission, Good Manufacturing Practices, United Kingdom, Global Development Teams, Grant In Aid, Marcel Dekker, Pharm Technol, Bridge Street Kingston, Code of Federal Regulations, Prepare Randomization, Appl Clin Trials, John Davis, John Green, Adv Drug Deliv Rev, Chem Eng News, Drug Deliv Technol, International Conference, Czech Republic

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Citations (learn more)

This book cites 100 books:

New Drug Approval Process, Fourth Edition, Accelerating Global Registrations (Drugs and the Pharmaceutical Sciences) by Richard Guarino on 4 pages
Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control (Drugs and the Pharmaceutical Sciences Series, Vol 78) by Sidney H. Willig on 4 pages
Modern Pharmaceutics by Gilbert S. Banker on 4 pages
Drug Stability: Principles and Practices (Drugs and the Pharmaceutical Sciences) by Jens T. Carstensen in Front Matter (1), Front Matter (2), and Front Matter (3)
Pharmaceutical Statistics: Practical and Clinical Applications, Fourth Edition, Revised and Expanded (Drugs and the Pharmaceutical Sciences) by Sanford Bolton in Front Matter (1), Front Matter (2), and Front Matter (3)

See all 100 books this book cites

6 books cite this book:

Active Pharmaceutical Ingredients: Development, Manufacturing, and Regulation (Drugs and the Pharmaceutical Sciences) by Stanley Nusim in Front Matter
Handbook of Pharmaceutical Granulation Technology, Second Edition (Drugs and the Pharmaceutical Sciences) by Dilip M. Parikh in Front Matter
Preclinical Drug Development (Drugs and the Pharmaceutical Sciences) by Mark C. Rogge in Front Matter
Spectroscopy of Pharmaceutical Solids (Drugs and the Pharmaceutical Sciences) by Harry G. Brittain in Front Matter
Pharmaceutical Process Scale-Up, Second Edition (Drugs and the Pharmaceutical Sciences) by Michael Levin in Front Matter

See all 6 books citing this book

Books on Related Topics (learn more)

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