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Author: A.N. Worden
Publisher: Springer Science & Business Media
ISBN: 9400932014
Category : Medical
Languages : en
Pages : 309
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Book Description
Reproduction and fetal development in humans and experimental animals may be adversely affected by a wide range of drugs and environmental agents. They may be toxic in the parental generation leading to impaired germ cell formation, loss of reproductive poten tial and infertility following chronic exposure. Deviant fetal development occurs as a consequence of cellular damage at sensi tive stages in development. Changes seen range from intrauterine mortality and structural malformation to growth retardation with physiological and behavioural defects. Concepts on the mechanism of action of teratogens are discussed with reference to some better-known agents. Presently, regulatory authorities prefer whole animal studies in predictive safety evaluation of substances to which a pregnant woman may be exposed. Tests are conducted over one or more generations and are designed to study the influence of test com pounds upon general reproductive performance, fertility, fetal development and perinatal and postnatal behaviour. Experiments are designed to permit compounds to be tested under conditions resembling expected human exposure. Small rodents and rabbits are preferred species on account of their convenience as laboratory animals and the available knowledge regarding their reproductive behaviour, fetal development and known sensitivity to human teratogens.
Author: A.N. Worden
Publisher: Springer Science & Business Media
ISBN: 9400932014
Category : Medical
Languages : en
Pages : 309
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Book Description
Reproduction and fetal development in humans and experimental animals may be adversely affected by a wide range of drugs and environmental agents. They may be toxic in the parental generation leading to impaired germ cell formation, loss of reproductive poten tial and infertility following chronic exposure. Deviant fetal development occurs as a consequence of cellular damage at sensi tive stages in development. Changes seen range from intrauterine mortality and structural malformation to growth retardation with physiological and behavioural defects. Concepts on the mechanism of action of teratogens are discussed with reference to some better-known agents. Presently, regulatory authorities prefer whole animal studies in predictive safety evaluation of substances to which a pregnant woman may be exposed. Tests are conducted over one or more generations and are designed to study the influence of test com pounds upon general reproductive performance, fertility, fetal development and perinatal and postnatal behaviour. Experiments are designed to permit compounds to be tested under conditions resembling expected human exposure. Small rodents and rabbits are preferred species on account of their convenience as laboratory animals and the available knowledge regarding their reproductive behaviour, fetal development and known sensitivity to human teratogens.
Author: D.V. Parke
Publisher: Springer Science & Business Media
ISBN: 9400941390
Category : Medical
Languages : en
Pages : 226
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Book Description
A. N. WORDEN, D. V. PARKE AND J. MARKS THE BACKGROUND There is nothing new about the fact that chemical substances derived either from natural products or by synthetic means .. can give rise to toxicity in animals and human beings, and that they must be subjected to controls. The earliest writings speak of such toxicity and, from the times of ancient Egypt and in the Old Tes tament, controls have existed[l]. In the Middle Ages Paracelsus (1493-1541) noted that "All things are poisons, for there is nothing without poisonous qualities. It is only the dose which makes a thing a poison", and hence he stressed the importance of dose relative to toxic reactions [ 2] . Most of the early controls concentrated on substances that were to be deliberately administered to the human subject in the form of medicines. Legislation for many centuries was mainly con cerned with regulating the activities of apothecaries and physicians. The Royal College of Physicians, for example, was originally established to control the activities of physicians within London. Among the controls which it exerted was that over the use of medicinal substances. Such controls were, however, poor, based as they were on hearsay evidence of toxicity. For many centuries no means existed for the accurate determination of toxicity.
Author: O'grady
Publisher: CRC Press
ISBN: 1000717771
Category : Medical
Languages : en
Pages : 748
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Book Description
Early Phase Drug Evaluation in Man is a comprehensive, practical guide that covers pre-clinical information relevant to early human studies, including pharmaceutical, metabolic, toxicological, and regulatory aspects, as well as the general considerations relevant to all early human studies. Each major therapeutic area is considered by class of activity of drug. The chapters describe what measurements of drug activity are available in healthy human subjects and in patients, how to make the measurements, their value and their limitations. The contributors have been drawn internationally from the pharmaceutical industry and academia. Early Phase Drug Evaluation in Man will provide an important reference guide for industry and academic professionals involved in the development of new drugs.
Author: Nimmo/Tucker
Publisher: CRC Press
ISBN: 9780849377310
Category : Medical
Languages : en
Pages : 240
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Book Description
Clinical measurement of the therapeutic and adverse effects of a drug is an important part of drug evaluation and registration. This volume presents full coverage of the principles and practice of the measurement of drug effects in humans and its role in the evaluation and development of new drugs. Clinical interpretation and relevance of data, as well as the acceptability and accuracy of methodology are emphasized together with the special problems of the cardiovascular system and the central nervous system. Contributions are from an international team of scientists and clinicians from both academia and industry. Clinical Measurement in Drug Evaluation will be useful for clinical and research scientists, research-based pharmacologists, and the pharmaceutical industry.
Author: Chi-Jen Lee
Publisher: CRC Press
ISBN: 1420039148
Category : Medical
Languages : en
Pages : 520
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Book Description
The pharmaceutical industry is on the verge of an exciting and challenging century. Advances in pharmaceutical sciences have dramatically changed the processes of discovery and development of new therapeutic drugs and, in turn, resulted in an extraordinary increase in the potential prophylactic and therapeutic interventions. In this atmosphere, an
Author: Arnold P. Reid
Publisher: CRC Press
ISBN: 9780849300981
Category : Technology & Engineering
Languages : en
Pages : 262
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Book Description
Many new ideas in project planning and cost control have been tried in the past 20 years. Some of them led to techniques taken for granted today. Others, that initially appeared logical and feasible, proved to be unworkable. Project Management supplies techniques that help with the planning and management of cost control. This book describes techniques currently used by systems engineers and project managers on major projects. It covers variations and modifications to suit different projects and management styles. The author takes a semi-procedural approach, using a minimum of words to give maximum information. He provides practical examples to illustrate each application. Experienced industrial managers know the essentials - good forward planning, budget control, and performance measurement - that maintain the viability of any project. Project Management puts these elements and functions into perspective. It gives experienced managers and young engineers alike the tools they need to see the big picture. Features
Author: Joy A. Cavagnaro
Publisher: John Wiley & Sons
ISBN: 1118679385
Category : Medical
Languages : en
Pages : 1012
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Book Description
"The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals Covers transitioning from preclinical development to clinical trials This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel.
Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1000458164
Category : Medical
Languages : en
Pages : 620
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Book Description
Before now, biological systems could only be expressed in terms of linear relationships, however, as knowledge grows and new techniques of analysis on biological systems is made available, we are realizing the non-linearity of these systems. The concepts and techniques of nonlinear analysis allow for more realistic and accurate models in science. The Future of Pharmaceuticals: A Nonlinear Analysis provides an opportunity to understand the non-linearity of biological systems and its application in various areas of science, primarily pharmaceutical sciences. This book will benefit professionals in pharmaceutical industries, academia, and policy who are interested in an entirely new approach to how we will treat disease in the future. Key Features: Addresses a new approach of nonlinear analysis. Applies a theory of projection to chalk out the future, instead of basing on linear evolution. Provides an opportunity to better understand the non-linearity in biological systems and its applications in various areas of science, primarily pharmaceutical sciences. Helps change the thought process for those looking for answers to their questions which they do not find in the linear relationship approach. Encourages a broader perspective for the creative process of drug development.
Author: Nicola Loprieno
Publisher: CRC Press
ISBN: 1000696782
Category : Medical
Languages : en
Pages : 221
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Book Description
First published in 1995: Alternative Methodologies for the Safety Evaluation of Chemicals in the Cosmetic Industry presents a categorization and collection of information available for the evaluation of safety using in vitro techniques. It offers a comprehensive and complete look at the entire field. In doing so, the author provides the foundation for the next phase of significant growth for this discipline.
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Publisher:
ISBN:
Category :
Languages : en
Pages : 254
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Book Description
