Kategoria BISAC: Medical >> Pharmacology

This volume covers:

Preclinical Drug Development, Second Edition discusses the broad and complicated realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology to industry trends and regulatory expectations to requirements that support clinical trials.

Highlights of the Second Edition include:

• Pharmacokinetics
• Modeling and simulation
• Formulation and routes of administration
• Toxicity evaluations
• The assessment of drug absorption and metabolism
• Interspecies scaling
• Lead...

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP...

To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. Active Pharmaceutical Ingredients is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally.

Topics include:

• Safety, efficacy, and environmental/regulatory requirements
• Analysis of the recent movement of API manufacturing from the U.S. and Europe to countries such as India and China
• The FDA's...

The Minipig in Biomedical Research is a comprehensive resource for research scientists on the potential and use of the minipig in basic and applied biomedical research, and the development of drugs and chemicals. Written by acknowledged experts in the field, and drawing on the authors global contacts and experience with regulatory authorities and the pharmaceutical and other industries, this accessible manual ranges widely over the biological, scientific, and practical uses of the minipig in the laboratory. Its coverage extends from the minipig s origins, anatomy,...

Animal Models in Toxicology is a single-source reference for the use of animal models in toxicology. Chapters cover nine species used in toxicology and experimental biology. With contributions from experts in toxicology, toxicological pathology, and species-specific metabolism, each of these chapters provides an excellent introductory "course" along with guidance to the literature for a more detailed understanding.

This edition includes five new chapters. The first of these provides specific and detailed guidance on the humane, efficient, and effective performance...

As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testing has been completely updated to include the most current information available, including new findings in drug delivery and dosage form design...

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

The first edition of this book was the seminal book on pharmaceutical extrusion, focusing on extrusion as a manufacturing methodology for dosage forms. In the past 10 years, extrusion has become an accepted technology to continuously mix active pharmaceutical ingredients with excipients. This acceptance has resulted in many hardware and process advancements which have been highlighted in this second edition. The book brings together all extrusion related technical information necessary for the development, manufacturing, and marketing of pharmaceutical dosage forms.

Much of the biology of oxidative stress and oxidative signalling centres on the generation and handling of hydrogen peroxide. The overall aim for this book would be to provide an insightful and useful forum to assist with the understanding of the relevance of hydrogen peroxide generation and how this is managed in human biology. The target audience would be those who currently have an interest in the generation of ROS, but who do not have expertise in chemistry, as well as those experts in the chemistry of oxidative stress, but without detailed understanding of the biologically relevant...