**Selected for Doody's Core Titles® 2024 in Toxicology** Reproductive and Developmental Toxicology, Third Edition is a comprehensive and authoritative resource, providing the latest literature on this complex subject by focusing on three core components - parent, placenta and fetus - and the continuous changes that occur in each. Enriched with relevant references describing every aspect of reproductive toxicology, this revised and updated resource addresses the totality of the subject, discussing a broad range of topics including nanoparticles and radiation, gases and solvents, smoking, alcohol and drugs of abuse, and metals, among others. In addition, it is the only resource to include reproductive and developmental toxicity in domestic animals, fish and wildlife With a special focus on placental toxicity, this book is the only available reference to connect the three key risk stages. Completely revised and updated to include the most recent developments in the field, this book is an essential resource for advanced students and researchers in toxicology, as well as biologists, pharmacologists and teratologists from academia, industry and regulatory agencies. - Provides a complete, up-to-date, integrated source of information on the key risk stages during reproduction and development - Offers diverse and unique in vitro and in vivo toxicity models for reproductive and developmental toxicity testing in a user-friendly format that assists in comparative analysis - Includes new chapters on developments in systems toxicology and predictive modeling of male developmental toxicity, adverse outcome pathways in reproductive and developmental toxicology, ovarian and endometrial toxicity, developmental neurotoxicity of air pollution, and more

Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development. Entirely focused on preformulation principles, this fully revised and updated Handbook of Preformulation: Chemical, Biological, and Botanical Drugs, Second Edition provides detailed descriptions of preformulation methodologies, gives a state-of-the-art description of each technique, and lists the currently available tools useful in providing a comprehensive characterization of a new drug entity. Features: Addresses the preformulation studies of three different types of new active entities - chemical, biological, and botanical, which is the latest established class of active ingredient classified by the FDA Illustrates the activities comprised in preformulation studies and establishes a method of tasking for drug development projects Includes extensive flow charts for characterization decision making Gives extensive theoretical treatment of principles important for testing dissolution, solubility, stability, and solid state characterization Includes over 50% new material

Includes history of bills and resolutions.

A comprehensive guide to optimizing the lifecycle management of pharmaceutical brands The mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create winning strategies, Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand explores this increasingly important field to help readers understand what they can—and must—do to get the most out of their brands. Offering a truly immersive introduction to LCM options for pharmaceuticals, the book incorporates numerous real-life case studies that demonstrate successful and failed lifecycle management initiatives, explaining the key takeaway of each example. Filled with practical information on the process of actually writing and presenting an LCM plan, as well as how to link corporate, portfolio, and individual brand strategies, the book also offers a look ahead to predict which LCM strategies will continue to be effective in the future. While the development of new drugs designed to address unmet patient needs remains the single most important goal of any pharmaceutical company, effective LCM is invaluable for getting the greatest possible value from existing brands. Pharmaceutical Lifecycle Management walks you through the process step by step, making it indispensable reading for pharmaceutical executives and managers, as well as anyone working in the fields of drug research, development, and regulation.

The 6th edition of this established text is streamlined to a more manageable format, with the Appendices moved to the web-site and a significant shortening of the main text. There is a greater focus on the global analysis of industry and competition; and analysis of the internal environment. In consultation with feedback from their adopters, the authors have concentrated on the fundamentals of strategy analysis and the underlying sources of profit. This reflects waning interest among senior executives in the pursuit of short-term shareholder value. As ever students are provided with the guidance they need to strategic planning, analysis of the health services environment (internal and external) and lessons on implementation; with additional discussionssion of organizational capability, deeper treatment of sustainability and corporate social responsibility and more coverageof the sources of organizational inertia and competency traps. This edition is rich in new examples from real-world health care organizations. Chapters are brought to life by the 'Introductory Incidents', 'Learning Objectives', 'Perspectives', 'Strategy Capsules', useful chapter summaries; and questions for class discussion. All cases and examples have been updated or replaced. In this edition the teaching materials and web supplements have been greatly enhanced, with power-point slides, to give lecturers a unique resource.

The book reviews the history of current brand and generic business in pharmaceuticals manufacturing practices. Based on examples, the reader can interpolate, extrapolate and exploit mutual behavior (physical and chemical properties) of chemicals to design and commercialize processes that fulfi ll the demands, also manipulate chemical unit processes and unit operations to reduce/minimize effl uents and lower environmental impact i.e. reduce global warming. Readers will be able to simplify process development, design and commercialize economic manufacturing processes.