Kategoria BISAC: Medical >> Pharmacology

Focusing on validation issues specific to the start-up of a new or upgraded manufacturing facility, this book provide definitions of the policies, guidelines, and regulations relating to Good Manufacturing Practices (GMPs) in pharmaceutical industries worldwide. The author discusses the validation concepts, definitions, and terminology associated with GMPs and details the philosophy and key principles of validation. He demonstrates how to set up an infrastructure for implementing a validation program. Included in the book are practical examples of validation documents and SOPs, a...

Thermoregulation is vital for survival but the interplay between toxic insults and thermoregulatory mechanisms is often poorly understood. Temperature and Toxicology: An Integrative, Comparative, and Environmental Approach is the first major text to study the integrative thermoregulatory responses of mammals that are exposed to toxicants. Because environmental physiology is also crucial in toxicological responses, this volume also examines the role of environmental temperature in the modulation of cellular mechanisms of toxicity.The book begins by explaining the importance of temperature in...

While one may not find ancient studies that substantiate the pomegranate's curative and preventive qualities, the exalted status of this fruit goes back as far as the history of agriculture itself. Allusions to the pomegranate are readily found in the oldest cultures of the Indus Valley, ancient China, and classical Greece, as well as in the Old Testament.

To modern scientists, the biochemistry of the pomegranate is as equally fascinating as its storied place in literature and religion. Providing an unprecedented compilation of scientific information, Pomegranates: Ancient Roots to Modern...

Everyone involved in pre-clinical, clinical, formulation, development and regulatory affairs will find Clinical Development a valuable resource. The book provides expert advice on ways to reduce delays and lost market opportunities, minimize development time, better understand the process and regulatory requirements, and plan and analyze clinical development and testing programs. The author combines text, graphs, and charts to show how a company moves a product through the complex process from discovery to market. The result is a complete analysis of the drug development process in...

Due to the tremendous accumulation of data for genetic markers, pharmacogenomics, the study of the functions and interactions of all genes in the overall variability of drug response, is one of the hottest areas of research in biomedical science. Statistical and Computational Pharmacogenomics presents recent developments in statistical methodology with a number of detailed worked examples that outline how these methods can be applied. This comprehensive volume provides key tools needed to understand and model the genetic variation for drug response and equips statisticians with a...

Written by leading scientists in the field of delivery of protein and peptide drugs to tumors for cancer therapy, this important book provides a broad introduction to the field, with discussion by key experts on the physiological barriers for protein and peptide drugs in tumors, and the different approaches to stabilization of these drugs in biological surroundings, as well as their enhanced delivery to tumors and inside cancer cells.This book can be used as an advanced textbook by graduate students and young scientists and clinicians at the early stages of their career. It is also suitable...

Advancing the development, validation, and use of patient-reported outcome (PRO) measures, Patient-Reported Outcomes: Measurement, Implementation and Interpretation helps readers develop and enrich their understanding of PRO methodology, particularly from a quantitative perspective. Designed for biopharmaceutical researchers and others in the health sciences community, it provides an up-to-date volume on conceptual and analytical issues of PRO measures.

The book discusses key concepts relating to the measurement, implementation, and interpretation of PRO...

Biopharmaceuticals are emerging as frontline medicines to combat several life-threatening and chronic diseases. However, such medicines are expensive to develop and produce on a commercial scale, contributing to rising healthcare costs. Developability of Biotherapeutics: Computational Approaches describes applications of computational and molecular modeling techniques that improve the overall process of discovery and development by removing empiricism.

The concept of developability involves making rational choices at the pre-clinical stages of biopharmaceutical drug...

Carefully designed for use by clinical and pharmaceutical researchers and scientists, Handbook of Regression Analysis and Modeling explores statistical methods that have been adapted into biological applications for the quickly evolving field of biostatistics. The author clearly delineates a six-step method for hypothesis testing using data that mimics real life. Relying heavily on computer software, he includes exploratory data analysis to evaluate the fit of the model to the actual data.
The book presents a well-defined procedure for adding or subtracting independent variables to the...

This title primarily focuses on the functional mechanisms and roles of Ca2+ channels in the central nervous system, and the effects of Ca antagonists on cytosolic CA2+ by blocking voltage sensitive channels. These findings are an important contribution to understanding the mechanisms of brain dysfunctions, including Alzheimer's disease, cerebral ischemia and affective disorders, as well as the effects of cytosolic CA2+ modulators on neuronal cell death. In addition the results of clinical trials are reported using typical and atypical Ca antagonists in the treatment of neuropsychiatric...

A brief history of drug design presented to make clear that there are fashions in this important field and that they change rather rapidly. This is due in part to the fact that the way that a new paradigm is accepted in a drug company often does not depend on its scientific merit alone.

A unique reference on peripheral pain receptor mechanisms

While considerable advances have been made on pharmacotherapies for many chronic disease states, options available to treat chronic pain have remained relatively unchanged for decades. However, utilizing the receptors involved in peripheral pain transduction mechanisms offers a significant opportunity to create novel therapies for pain.

A comprehensive review of peripheral pain mechanisms, Peripheral Receptor Targets for Analgesia: Novel Approaches to Pain Management provides a unique resource that brings...