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The Pharmaceutical Regulatory Process
This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, an
The Pharmaceutical Regulatory Process
Providing in-depth coverage of the procedures utilized by pharmaceutical companies for regulatory compliance, this reference describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States-standing alone as the only authoritative guide to address the complex web of regulatory requirements, application processes, and quality control issues influencing the pharmaceutical industry.
The Pharmaceutical Regulatory Process, Second Edition
This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval. New chapters cover: the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance pharmacovigilance programs designed to prevent widespread safety issues legal issues surrounding the sourcing of foreign APIs the issues of counterfeit drugs updates on quality standards
Validation of Active Pharmaceutical Ingredients
Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated, and expanded, this second edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. The basic philosophy and principles of GMP and validation have not changed, but new terminology had been introduced, and old terminology had been better defined, improving the understanding of related concepts and principles. The book gives you a working knowledge of the regulatory process that will facilitate your organization's compliance with regulations.
Pharmaceutical Process Validation, Second Edition
The second edition of this text has been updated and enlarged to reflect current good manufacturing practice (CGMP) regulations and the increased interest in, and applicability of, process validation. "Pharmaceutical Process Validation" offers up-to-the-minute coverage of: regulations and validation; sterile process validation; organization in validation processes; solid dosage forms validation; raw material validation; analytical methods validation; and prospective and retrospective validation. Providing the contributions of leading experts in the field, the text also supplies examinations of current concepts in validation and new topics, such as: validation of cleaning systems and computer systems; equipment and water systems validation; and lyophilized and aerosol product validation.
Northern Spy
Reese’s Book Club Pick Instant New York Times Bestseller A New York Times Book Review Top 10 Thriller of 2021 A Washington Post Top 10 Thriller or Mystery of 2021 “If you love a mystery, then you’ll devour [Northern Spy] . . . I loved this thrill ride of a book.”—Reese Witherspoon “A chilling, gorgeously written tale . . . Berry keeps the tension almost unbearably high.” –The New York Times Book Review The acclaimed author of Under the Harrow and A Double Life returns with her most riveting novel to date: the story of two sisters who become entangled with the IRA A producer at the BBC and mother to a new baby, Tessa is at work in Belfast one day when the news of another raid ...
Pharmaceutical Process Validation
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
Handbook of Pharmaceutical Analysis
Exploring the analysis of pharmaceuticals, including polymorphic forms, this book discusses regulatory requirements in pharmaceutical product development and pharmaceutical testing. It covers methods of drug separation and procedures such as capillary electrophoresis for chromatographic separation of molecules. Additional topics include drug formulation analysis using vibrational and magnetic resonance spectroscopy and identification of drug metabolites and decomposition products using such techniques as mass spectrometry. The book provides more than 300 tables, equations, drawings, and photographs, and convenient, easy-to-use indices, facilitating quick access to each topic.
Development and Formulation of Veterinary Dosage Forms
Although the United States (U.S.) and the more developed nations of the remainder of the world are blessed with a variety of pharmaceuticals, feed additives, and biological products to treat, prevent, and control animal diseases, there is a healthy desire among persons involved in animal health issues to increase our animal medicine chest. The interest stems from the desire to efficiently produce food that is safe and plentiful and from the desire to have more and better government-approved products available for the prevention and treatment of diseases of dogs, cats, and horses and for an increasing variety of minor animal species. For the animal health industry, increased drug availability means broader markets, increased revenues, and an opportunity to better serve their customers. For the veterinarian, more animal health products means that he or she is better able to treat the usual and the unusual conditions, and to prevent animal disease and suffering. No doubt, we are all winners when new technology and industrial and regulatory initiatives hasten the availability of safe and effective animal health products.
