Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form, Second Edition

This timely Second Edition reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, and the shift from developing small molecules to the growth of biopharmaceuticals. It meets the need for up-to-date and advanced information for drug preformulation and formulation, and addresses the current trends in the continually evolving pharmaceutical industry.

Ideal for practitioners working in the pharmaceutical industry (including R&D scientists, technicians, and managers), as well as undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology, this text addresses:

candidate drug selection drug discovery and development preformulation predictions and drug selections product design to commercial dosage form biopharmaceutical support in formulation development and more.

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Smith and Williams' Introduction to the Principles of Drug Design and Action, Fourth Edition

As knowledge of biological systems has expanded and the number of techniques available for exploring and visualizing their components has increased, it has become possible to design drugs specifically for a given target. This unique insight has revolutionized the process of drug development for specific disease states. Smith and Williams' Introduction to the Principles of Drug Design and Action, 4th Edition provides a thorough introduction to the principles of rational drug design, including both novel and established approaches. The fourth edition of this popular textbook adopts a 'from the bench to the marketplace' approach, using real examples where possible. In addition to a comprehensive update of the previous edition, new advances in molecular techniques, biotechnological applications and computer-aided design have been added.

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Chemistry of Drugs (New Chemistry)

Drug development and research offer some of the most challenging and exciting research in the field of chemistry. "Chemistry of Drugs" provides an introduction to the most common processes by which chemists design and develop drugs today. It describes the chemical principles on which those processes are based, along with an overview of the applications and hazards associated with a variety of drugs available both legally and illegally.Coverage also includes attempts to find and develop new natural products for use as drugs; the potential for curing diseases, such as cancer; the growing field of biotechnology; and combinational chemistry, a method of producing, evaluating, and developing new chemical compounds with possible value as drugs. Designer drugs are also discussed, as well as important social, economic, and political issues related to the development and use of drugs. Biographical information on many influential figures involved in the advancement of this field throughout history completes this enlightening volume.

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Clinical Pharmacokinetics: Concepts and Applications

Since pharmacokinetics can greatly affect how different patients respond to the same drug, both students and physicians need a basic clinical understanding of this vital area. The Third Edition of "Clinical Pharmacokinetics" provides a practical perspective, with these added features: considerations of both stereochemistry and the increasing number of polypeptide and protein drugs being developed; the range and number of problems at the end of each chapter has been expanded; a second color added to make the text more user friendly; and, important equations highlighted by shading.

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Statistical Issues in Drug Development

Statistics in Practice A new series of practical books outlining the use of statistical techniques in a wide range of application areas:
* Human and Biological Sciences
* Earth and Environmental Sciences
* Industry, Commerce and Finance
Statistical Issues in Drug Development Stephen Senn Professor of Pharmaceutical & Health Statistics, University College, London Statistical Issues in Drug Development provides an accessible text for those working directly in drug development, regulatory and marketing departments within the pharmaceutical industry. As a consequence of regulatory authorities demanding increasingly higher standards, statistics has become a critical element in the design and conduct of drug development programmes. The concepts covered in this volume guide the non-statistician through the most pressing statistical issues and controversies in drug development. Key issues covered include:
* Design & interpretation of clinical trials
* Bayesian & frequentist methods
* Sequential & cross-over trials
* Drug monitoring & pharmaco-economics
The book has been prepared in two sections. The first section considers the role of statistics in drug development from four different perspectives: historical, philosophical, technical and professional. The second section covers a series of controversial topics such as fixed versus random effects for meta-analysis, one-sided versus two-sided tests and the ethics of placebo run-ins. The approachable and wide-ranging coverage of this book will make it invaluable to all those working in drug development and regulation.

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Biopharmaceutical Process Validation

A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, reduce the risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterize processes, process intermediates, and final product fully. The text emphasizes cost effectiveness while determining what level of validation is required for different phases of development, license application, and process improvements.

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Drug Discovery: From Bedside to Wall Street

Everyone expects something from the drug industry. Physicians and patients, investors, regulators and administrators all have an active interest. Everyone wants to know what makes drugs 'work' medically and economically. Why are drugs so expensive? Is it the drug companies or investors who demand high profits? What governs the pharmacoeconomics? Why are so few diseases treatable? 

This book opens the windows and doors of the industry telling the story of drug development by using real stories from inside the process. 

* Co-written by Graham Lees and Tamas Bartfai who has been involved in the development of drugs taken by more that 20 million people every day 

* Opens the windows and doors of the most regulated industry in the world, the pharmaceutical industry 

* Tells the story of drug development by using real examples based on current research and events 

* Provides an objective, lucid account of the successes and failures, shortcomings and constraints of the pharmaceutical and biotech industries

* Gives insights into the development of new drugs to combat multiple conditions including cancer and pain 

* Balanced, unbiased account of how better to translate basic science into drug discovery.

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Fundamentals of Clinical Research - Statistics for Biology and Health

In recent years many introductory textbooks on clinical trial methodology have been published, some of which are excellent, in addition to a very extensive specialist literature. Nevertheless, here is a new book on methods and issues in clinical research. The objectives can be summarized in three points.

1. Integrate medical and statistical components of clinical research. 

2. Do justice to the operational and practical requirements of clinical research. 

3. Give space to the ethical implications of methodological issues in clinical research.

The scope of clinical research is to evaluate the effect of a treatment on the evolution of a disease in the human species. The treatment can be pharmacological, surgical, psychological/behavioral or organizational/logistic. The disease, intended as an impairment of a state of well-being or a condition capable of provoking such impairment over time, can be universally accepted as such (e.g. a cancer or a bone fracture) or perceived as such only by limited groups of individuals in a given cultural context (e.g. hair loss or weight gain). The course of the disease that ones wishes to change can be the one with no intervention or, more frequently, the one observed with the available treatment. The evaluation of the effect of a treatment on the course of a disease is a lengthy process, which progresses in increasingly complex stages.

A detailed coverage of the logistic, administrative and legal aspects of clinical research is outside the scope of this book. However, throughout the book we keep reminding the reader of these aspects because, as already mentioned, we firmly believe they have a crucial role in determining the success of a study. The history of clinical research is paved with relics of studies started with great pomp, riding great ideas and great hopes, which drowned miserably because of inadequate logistical preparation. In our experience, the excessive complexity of a clinical trial is the single most frequent cause of failure: the study is perfect on paper, but impossible to implement by patients and staff alike. The distance between the principal investigators and the reality of clinical research in its day-to-day practice is often the main cause of such disasters. We warmly encourage everyone involved in clinical research to get involved in the logistics of a study, learning from colleagues responsible for its practical conduct (clinical research associates, data managers, etc.) and to take part, in person, in the practical implementation of a trial before attempting to design a study protocol.

The book ends with a brief description of the drug development process and to the phases of clinical development.

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Particulate Interactions in Dry Powder Formulation for Inhalation

Interactions between drug particulates are crucial in determining drug dispersion and deaggregation, and ultimately delivery efficiency. This book combines principles and factors in pharmaceutical powder technology, critically reviews some of the studies carried out in dry powder formulation development, and proposes possible strategies for improving their efficiency. The majority of these principles are applicable to other pharmaceutical solid dosage forms (e.g. tablets and capsules).

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Drug Products for Clinical Trials: An Intl Guide to Formulation, Production, Quality Control

This practical guide shows how the appropriate use of clinical materials can increase efficiency in bringing new products to the marketplace;offering authoritative assessments of the scientific and legal issues involved in the successful completion of clinical trials for marketing approval by regulatory agencies. The only wide-ranging, up-to-date book of its kind available on the subject! Describing both the science and management of product development, Drug Products for Clinical Trials furnishes effective approaches for preclinical drug discovery addresses the function of the clinical trials materials manager covers the design of clinical protocols in developing a new chemical entity (NCE) explains the importance of bioequivalence between clinical trials materials and final products demonstrates rapid, reliable processes for clinical evaluation discusses the interaction between clinical research, manufacturing, and packaging reviews quality control strategies used in the manufacture of drug substances for clinical studies conducted throughout the world and much more!

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Handbook of Drug Metabolism, Second Edition

This timely, expanded new edition is the definitive handbook for experienced drug metabolism and pharmaceutical scientists and those new to the field.

Written by internationally renowned authors, it provides integrated, comprehensive coverage of fundamental aspects of drug metabolism and the practical applications that help guide researchers through key challenges in modern drug discovery and development.

The Second Edition covers the many recent scientific and technical advances in the field, and is organized in four sections – ideal for use in undergraduate and graduate programs in Drug Metabolism and Clinical Pharmacology.

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Pharmacokinetics: Regulatory, Industrial, Academic Perspectives

Offering a unique, multidisciplinary approach, this state-of-the-art Second Edition details the rapidly changing role that clinical and non-clinical pharmacokinetics and drug metabolism play in the discovery and development of drug therapies -- emphasizing often overlooked regulatory, scientific, and economic issues.

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High-Throughput Analysis in the Pharmaceutical Industry

High throughput analysis plays a critical role in the pharmaceutical industry. The ever-shortening timelines and high costs of drug discovery and development have brought about the need for high throughput approaches to methods that are currently used in the industry. Written and edited by well-known contributors who remain active in this line of research, this book systematically describes high throughput analysis for the pharmaceutical industry, including advanced instrumentation and automated sample preparation. The text discusses various techniques, including HPLC, MALDI-MS, and LC-MS/MS methods, with an emphasis on the later stage of drug development, including pharmacokinetics.

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Drug Delivery Systems, Second Edition

Drug delivery technologies represent a vast and vital area of Research and Development. The demand for innovative drug delivery systems continues to grow, and this growth continues to drive new developments. Building on the foundation provided by the first edition, Drug Delivery Systems, Second Edition covers the latest developments in both industry and academia. New in this edition: · Chapter focusing on novel technologies and their global outlook · Coverage of electronically controlled drug delivery · Macrocapsules and nanoparticles in drug targeting · Drug nanocrystals and other new delivery systems · Updated information on liposomes as carriers Written in a straightforward, clear, and concise manner, the author provides a global perspective on current and future advances and market opportunities. Drug Delivery Systems, Second Edition answers the need for comprehensive information in a single resource for anyone venturing into this area of drug development.

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Dose Optimization In Drug Development

This reference provides a concise overview of the key principles in dose selection and optimization and demonstrates applicability to recent successful new drug applications. Compiling key issues and current research on safety, efficacy, and clinical pharmacology, and PK-PD, this volume critically highlights the multidisciplinary nature of drug development and spans the fields of pharmacokinetics, clinical pharmacology, biostatistics, and experimental medicine.

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Water Properties of Food, Pharmaceutical, and Biological Materials

Unique and informative, Water Properties of Food, Pharmaceutical, and Biological Materials is based on lectures and papers given by leading international researchers at the 9^th

International Symposium of the Properties of Water in Foods (ISOPOW 9) that took place in September 2004. Each chapter presents an authoritative account of the latest research on the physical and chemical properties of water in relation to the stability of food, pharmaceutical, and biological materials.

The first part of the text focuses on presentations given by invited speakers, whereas the second part is dedicated to oral presentations and discussions. Topics include the role of water in structural and functional properties, preserving biomolecule functionality in restricted water environments, and micro- and nano- techniques used for assessing water-solid interactions in food and drug development.

This book is an invaluable resource that synthesizes cutting-edge information with innovativeviewpoints from internationally esteemed researchers who participated in ISOPOW 2004

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Pharmacokinetics in Drug Discovery and Development

Pharmacokinetics has evolved from its origin into a complex discipline with numerous subspecialties and applications in patient management, drug development, and regulatory issues. This expansion has made it difficult for any one individual to become a full-fledged expert in all areas. Fulfilling the need for a wide-ranging guide to the many existing subspecialties in this field, Pharmacokinetics in Drug Discovery and Development details the different areas in the field providing the ideal comprehensive, quick access text and reference. After an introduction of basic principles, the book is divided into sections that cover industrial and regulatory applications, clinical applications, and research applications. The following sections cover such topics as PK/PD approaches, clinical pharmacokinetic monitoring, population pharmacokinetics, linear systems approaches, and more. Fourteen authors, each an expert in his/her area of expertise, provide an extensive background into the subspeciality with emphasis on the section's theme. Covering the many sub-disciplines and providing pharmacokinetic concepts, terminology, and approaches, Pharmacokinetics in Drug Discovery and Development serves as a resource for professionals throughout this field.

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Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form

Written by a panel of experts, this book covers every stage of drug development, from candidate drug selection to commercial formulation. It provides practical reference and pragmatic guide on what studies need to be undertaken, for what reasons, and at what key stages of the drug development process. Going beyond coverage of preformulation, the book discusses biopharmaceuticals, drug delivery, formulation, and process development aspects of product development. The contributing authors share their experience and expertise in significant chapters divided into three useful sections: Aiding Candidate Drug Selection, Early Drug Development, and From Product Design to Commercial Dosage Form. Features.

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Pharmaceutical Design And Development: A Molecular Biology Approach

This volume aims to introduce researchers in pharmaceutical and allied industries to the concepts and latest developments in the application of biotechnology recombinant DNA and monoclonal antibodies to drug development. The author puts biotechnology in perspective, introducing the basic concepts of cell and molecular biology and discussing both the application of protein drugs and the design of new molecular entities. The study examines the use of proteins and assay systems produced via biotechnology to the development of small-molecule drugs. A discussion of gene and somatic cell therapies is included, along with developments in diagnostic methods resulting from biotechnology. The text concludes by examining future prospects and likely developments in the field.

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Modified-Release Drug Delivery Technology

Describing formulation challenges and their solutions in the design, development, and commercialization of modified-release drugs delivery systems, this book contains eighty papers that review recent developments in design and manufacturing techniques. It includes detailed descriptions of extended release drug products for the oral, nasal, ophthalmic, pulmonary, vaginal, dermal and transdermal pathways. With the exception of the final section addressing regulatory issues, each section covers a particular route for drug delivery and opens with an overview of the anatomical, physiological, and pharmaceutical basics of each route before moving on to cover specific technologies.

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