Examining how to maintain assured quality in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides solid foundations, tips, and techniques for establishing a quality system that will comply with the relevant regulations.
Presenting all the information your students need in an accessible layout, Essentials of Pathophysiology for Pharmacy will give students a practical understanding of the pathophysiologic basis of selected diseases while providing a rationale for subsequent drug therapy.
Delivering an encompassing overview of the factors, varieties, and applications determining product containment, this concise reference provides authoritative information on containment processes.
Virtual screening can reduce costs and increase hit rates for lead discovery by eliminating the need for robotics, reagent acquisition or production, and compound storage facilities.
Critical in the elimination of drugs and other xenobiotics from the body, cytochrome P450 has strong bearing on scientific assessments of genetic polymorphism in metabolism, possible drug-drug interactions, and bioavailability of candidate drugs.
Fluorescence-based sensing is a significant technique used in prominent fields such as fluorescence-activated cell sorting, DNA sequencing, high-throughput screening, and clinical diagnostics.
The broad range of G protein-coupled receptors (GPCRs) encompasses all areas of modern medicine and have an enormous impact on the process of drug development.
As pharmaceutical companies look to develop single enantiomers as drug candidates, chemists are increasingly faced with the problems associated with this subclass of organic synthesis.
With the successful mapping of the human genome, we have entered an age of unprecedented opportunity in which researchers are beginning to apply this vast repository of knowledge to the treatment of human disease.
Because enzyme-catalyzed reactions exhibit higher enantioselectivity, regioselectivity, substrate specificity, and stability, they require mild conditions to react while prompting higher reaction efficiency and product yields.
Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines.
This guide contains over 20,000 entries completely cross-indexed and quoted in context to provide readers with instant access to every noun, phrase, and concept used by the Drug Enforcement Administration and U.
Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on.
Contamination control in pharmaceutical clean rooms has developed from a jumble of science and engineering, knowledge of what has worked well or badly in the past, dependent upon the technology available at the time the clean room was built and subsequent technological developments.
Often considered a necessary evil by the pharmaceutical industry, validation is still understood by many as unrestrained bureaucracy, paperwork, and procedures whose roots and logic are obscure and only serve to slow down progress.
Completely revised and updated, Pharmaceutical Experimental Design and Interpretation, Second Edition explains the major methods of experimental design and evaluation such as multivariate, sequential, and principal components analysis.
Since the last major compendium dedicated to cyclic nucleotide phosphodiesterases (PDEs) was published over 15 years ago, an enormous amount of progress has occurred in the field.
This source expertly examines the discovery, biological structure, control, and continued clarification of endotoxin from a parenteral manufacturing perspective, with in-depth discussion of state-of-the-art technologies involving Limulus amebocyte lysate (LAL) such as assay development, automation, depyrogenation.
Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms.
This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc.
The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients.
Pharmaceutical Dosage Forms: Tablets, Third Editionis acomprehensive treatment of the design, formulation, manufacture, and evaluation of the tablet dosage form.
Pharmaceutical Dosage Forms: Tablets, Volume 1examines the fundamental physical and chemical processes that the different unit oprations use, and then applies this knowledge to the discussion of the varying unit operations and processes.
Furnishing essential data on all areas of toxicity testing, this Second Edition provides guidance on the design and evaluation of product safety studies to help ensure regulatory acceptance.
During the last two decades, the pharmaceutical industry has been under pressure to reduce development costs and the time needed to bring drugs to market in order to maximize return on investment and bring treatments to patients sooner.
Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products.
The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart.
Over the last decade, enormous progress in the understanding of T-cell homing has made it possible to identify the multitude of molecules involved, such as cytokines, chemokines, and adhesion molecules, and to unravel their complex interactions resulting in controlled, non-random T-cell recirculation.
Designed as a practical guide for the pharmaceutical industry, this book covers how to apply cutting-edge marketing concepts and tools to the real-world intricacies of marketing a heavily regulated product whose success is determined not by the actual end-user, but by various industry stakeholders.
Sponsor companies and CROs alike will appreciate the industry-wide analysis, practical, how-to advice, and helpful charts and checklists provided by Outsourcing in Clinical Drug Development.
When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guideline that define exactly how such a system has to be built.
Designed to enable readers to plan and execute their own audits, this comprehensive guide presents discussions of and practical applications related to establishing a GLP QA unit and performing effective GLP audits.
Increasingly, pharmaceutical scientists must not only be specialists in their field but must also be familiar with legislation that governs the use of equipment in their industry.
The microfluidic lab-on-a-chip allows scientists to conduct chemical and biochemical analysis in a miniaturized format so small that properties and effects are successfully enhanced, and processes seamlessly integrated.
Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance.
The handling and analysis of data generated by proteomics investigations represent a challenge for computer scientists, biostatisticians, and biologists to develop tools for storing, retrieving, visualizing, and analyzing genomic data.
The Handbook of Carbohydrate Engineering provides an overview of the basic science, theory, methods, and applications of this broad, interdisciplinary field.
This reference provides a concise overview of the key principles in dose selection and optimization and demonstrates applicability to recent successful new drug applications.
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.
Oral lipid-based formulations are attracting considerable attention due to their capacity to facilitate gastrointestinal absorption and reduce or eliminate the effect of food on the absorption of poorly water-soluble, lipophilic drugs.
Taking readers from the research laboratory to the bedside, this Second Edition compiles essential information on the pharmacodynamics of all major classes of the antimicrobial armamentarium including penicillins, cephalosposorins, cephamycins, carbapenems, monobactams, aminoglycosides, quinolones, macrolides, antifungals, antivirals, and emerging
The only source on the subject to offer both an overview and a disease-based approach, this reference text spans the wide array of technical, methodological, regulatory, and ethical issues related to pharmacogenetics and stresses the impact of pharmacogenetic data on patient care and management.
