Carefully crafted to provide tightly focused and authoritative information, the Directory of Therapeutic Enzymes covers all approved therapeutic enzymes currently used in medicine.
Now for the first time, one comprehensive book summarizes and analyzes the numerous scientific papers and reviews covering selected aspects of the structure, biological activities, and clinical effects of immune interferon, also known as interferon-gamma(IFN-gamma).
Exploring how to apply in vitro/in vivo correlations for controlled release dosage forms, Bioavailability of Drug Delivery Systems: Mathematical Modeling clearly elucidates this complex phenomena and provides a guide for the respective mathematical modeling.
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.
Completely revised and expanded to reflect the latest advancements in the field, Polysaccharides: Structural Diversity and Functional Versatility, Second Edition outlines fundamental concepts in the structure, function, chemistry, and stability of polysaccharides and reveals new analytical techniques and applications currently impacting the cosmetic, medicinal, chemical, and biochemical industries.
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.
Presenting breakthrough research pertinent to scientists in a wide range of disciplines-from medicine and biotechnology to cosmetics and pharmacy-this Second Edition provides practical approaches to complex formulation problems encountered in the development of particulate delivery systems at the micro- and nano-size level.
Several books on the market cover combinatorial techniques, but they offer just a limited perspective of the field, focusing on selected aspects without examining all approaches and integrated technologies.
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.
Containing authoritative and in-depth coverage, Producing Biomolecular Materials Using Fermenters, Bioreactors, and Biomolecular Synthesizers examines the bioproduction systems that support the controlled, automated, and quantity growth of proteins.
With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change.
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.
This revised edition of a bestseller provides a logical, step-by-step guide to testing new drugs and treatment modalities in compliance with the latest FDA regulations.
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.
