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Good Drug Regulatory Practices

Good Drug Regulatory Practices offers a series of policies and procedures to assure quality and timely regulatory submissions to national;

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Pharmaceutical Analysis for Small Molecules

pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products;

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Pharmaceutical Manufacturing Handbook

With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process;

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Medical Product Regulatory Affairs

regulatory affairs in all major global markets for pharmaceuticals and medical devices. Following a look at drug development, complete sections are;

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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;

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Drug Delivery Trends

Realities of Multifunctional Drug Delivery Systems examines the fabrication, optimization, biological aspects, regulatory and clinical success;

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Pharmaceutical Dosage Forms

Food and Drug Administration's (FDA) Current Good Manufacturing Practices; places special emphasis on methods of detecting, counting and sizing;

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Analytical Testing for the Pharmaceutical GMP Laboratory

development best practices used to maintain the quality and integrity of medicines. With a focus on smaller molecular weight drug substances and;

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Drug-Drug Interactions: Scientific and Regulatory Perspectives

DrugDrug Interactions is a comprehensive review of the scientific and regulatory perspectives of drugdrug interactions from the;

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Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2014

of medicines in or for Europe. It is compiled by the UK drug regulatory body, the MHRA, and brings together the European and UK guidance documents and;

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Interface between Regulation and Statistics in Drug Development

: Regulatory and statistical interactions throughout the drug development continuum The critical role of the statistician in relation to the;

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Interface between Regulation and Statistics in Drug Development

: Regulatory and statistical interactions throughout the drug development continuum The critical role of the statistician in relation to the;

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Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics

This book describes the authors' standard or 'best' practices used in writing regul- ed clinical documents for the drug and biologics;

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Delivery of Drugs

, optimization, scale-up, biological aspects, regulatory and clinical success of various micro and nano drug delivery systems. The volume covers site and;

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Guidebook for Drug Regulatory Submissions

The high-stakes process of submitting drug documents and applications for regulatory review can be intimidating, particularly for the;

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Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems

To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new excipients to be developed;

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Drug Delivery Aspects

on formulation engineering and related large scale (GMP) manufacturing, regulatory, and functional aspects of drug delivery systems. A;

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Specification of Drug Substances and Products

them. Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products;

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New Drug Development

Highlighting key points from the latest regulatory requirements, New Drug Development helps those new to the world of pharmaceutical;

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Considering the Patient in Pediatric Drug Development

Union's (EU) regulatory authorities, pediatric academia, and the pharmaceutical industry demand, support and perform pediatric drug studies, along;

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Regulatory Intelligence as the Basis for Regulatory Strategy and Global Drug Development

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Stronger Food and Drug Regulatory Systems Abroad

and roughly 8,500 to 20,000 malaria deaths in sub-Saharan Africa alone. The Federal Drug Administration (FDA) Office of Global Policy and;

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Red Blood Cell Substitutes: Basic Principles and Clinical Applications

substitute products, and global tranfusion practices from the perspective of blood banks and the US Food and Drug Administrations. It also includes;

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Building a National Framework for the Establishment of Regulatory Science for Drug Development

The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong;

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Nanopharmaceuticals

fabrication, optimization, biological aspects, regulatory and clinical success of wide range of drug delivery carriers. This series reviews;

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Overdose

of making pharmaceutical products today, and he assesses which current legal and regulatory practices make sense and which have gone awry;

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Long-Acting Drug Delivery Systems: Pharmaceutical, Clinical, and Regulatory Aspects

Long-Acting Drug Delivery Systems: Pharmaceutical, Clinical, and Regulatory Aspects offers a comprehensive overview of the technical;

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