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.
Offering a wide array of illustrations and tables in every chapter, this book extensively covers the principles of allosterism in reference to drug action and progresses to a detailed examination of individual ionotropic and G-protein coupled receptor systems-helping those new to the subject understand the importance of allosterism and providing th
While the genomic revolution has quickly led to the deposit of more than 30,000 structures in the protein data bank (PDB), less than one percent of those contributions represent membrane proteins despite the fact that membrane proteins constitute some 20 percent of all proteins.
The biopharmaceutical industry has become an increasingly important player in the global economy, and the success of these products depends on the development and implementation of cost-effective, robust and scaleable production processes.
Continuing advances in biomedical research and statistical methods call for a constant stream of updated, cohesive accounts of new developments so that the methodologies can be properly implemented in the biomedical field.
Adopting a unifying theme based on maximum statistics, Multiple Comparisons Using R describes the common underlying theory of multiple comparison procedures through numerous examples.
Pharmacy is the nation's third largest health profession, with nearly 200,000 licensed pharmacists in the United States and 125,000 practicing in community pharmacies.
Polymeric materials are now playing an increasingly important role in pharmaceuticals, as well as in sensing devices, in situ prostheses and probes, and microparticle diagnostic agents.
Pharmacokinetics has evolved from its origin into a complex discipline with numerous subspecialties and applications in patient management, drug development, and regulatory issues.
An ideal text for biotechnologists, protein chemists, and biochemists, Functional Protein Microarrays in Drug Discovery explores all aspects of functional protein microarrays, including basic principles, methods, and applications.
Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles the current regulatory requirements to correctly and properly validate a new or modified analytical method.
A True Insider's Guide to the Field - Then and Now Until now, there has not been a book that effectively addresses the historical basis of protein discovery.
An invaluable source instruction on the principles, instrumentation, design, implementation, operation, and maintenance of an effective clean-in-place system (CIP), this guide illustrates best practices and successful applications of CIP in both pharmaceutical and biotechnology facilities.
Encompassing the full spectrum of project management's role and responsibility encountered in the pharmaceutical industry, Pharmaceutical Project Management outlines the key objectives, risks, and challenges of each stage of the pharmaceutical lifecycle, from discovery and preclinical phases through clinical development, manufacturing, registration
Pharmaceutical Packaging Handbook provides a complete overview of the role that packaging plays in the development and delivery of pharmaceuticals and medical devices.
Preeminent Experts Update a Well-Respected BookTaking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequiva
A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments.
Divided into three expansive sections on biotechnological advances, applications, and research prospects, this reference provides expert summaries of the state-of-the-science in personal care product development-clearly depicting the latest breakthroughs and practices in biotechnology for the formulation and increased safety of new personal care in
In the fiercely competitive pharmaceutical marketplace, your organization cannot afford to spend excess dollars developing drugs that will fail to get FDA approval or have profoundly poor characteristics.
Integrating various technologies with informational systems provides vast improvements to the overall research and development that occur in the biopharmaceutical industry.
The pharmaceutical industry relies on numerous well-designed experiments involving high-throughput techniques and in silico approaches to analyze potential drug targets.
Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production.
With the advent of analytical techniques and capabilities to measure particle sizes in nanometer ranges, there has been tremendous interest in the use of nanoparticles for more efficient methods of drug delivery.
As pharmaceutical companies strive to develop safer medicines at a lower cost, they must keep pace with the rapid growth of technology and research methodologies.
An ever-increasing demand for better drugs, elevated safety standards, and economic considerations have all led to a dramatic paradigm shift in the way that drugs are being discovered and developed.
To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new, yet to be developed, and approved excipients continues to increase.
This book reviews the history, regulatory status, pharmacopeial specifications, and harmonization of pharmaceutical excipients in the United States and Europe, and provides a comprehensive understanding of the current scientific basis for safety evaluation and risk assessment.
