The increased use of non-inferiority analysis has been accompanied by a proliferation of research on the design and analysis of non-inferiority studies.
This title demonstrates how advanced formulation designs and delivery technologies can be used to improve drug efficacy and treatment outcomes in particular therapeutic categories or disease states.
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.
This text defines the role and scope of nuclear medicine imaging techniques (gamma scintigraphy) in pharmaceutical research, giving information from clinical trial data.
With over 100 illustrations, Volume 1 addresses the core disciplines of pharmaceutics (absorption, PK, excipients, tablet dosage forms, and packaging), and explores the challenges and paradigms of pharmaceutics.
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.
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.
Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation.
Pharmaceutical Dosage Forms: Tablets, Third Editionis acomprehensive treatment of the design, formulation, manufacture, and evaluation of the tablet dosage form.
It is estimated that 80 to 90% of drugs under development never make it to the marketplace due to insufficient clinical activity, unacceptable toxicity, rapid appearance of drug resistance, or other factors that should be, at least partially, predictable from preclinical testing.
This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments.
Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies.
Colloidal drug delivery systems present a range of therapeutic benefits in the treatment of a number of challenging conditions, allowing researchers to cross barriers that have previously prevented efficient treatment while offering improved and more targeted absorption.
Advances in pharmacogenomics and proteomics, along with the introduction of recombinant DNA technology, have expanded the applications of pharmacology to encompass a range of disciplines.
This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development.
As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH).
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
Statistical evaluation of diagnostic performance in general and Receiver Operating Characteristic (ROC) analysis in particular are important for assessing the performance of medical tests and statistical classifiers, as well as for evaluating predictive models or algorithms.
With contributions from recognized authorities in industry, academia, and government, this reference presents the state-of-the-art in the testing, formulation, and clinical evaluation of intraoral drug delivery products-summarizing intraoral dosage forms in various stages of research, as well as products currently on the market.
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.
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.
The Handbook of Carbohydrate Engineering provides an overview of the basic science, theory, methods, and applications of this broad, interdisciplinary field.
Design and Analysis of Cross-Over Trials is concerned with a specific kind of comparative trial known as the cross-over trial, in which subjects receive different sequences of treatments.
Antibodies protect us from a wide range of infectious diseases and cancers and have become an indispensable tool in science-both for conventional immune response research as well as other areas related to protein identification analysis.
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.
The activity of many biopharmaceutical polymers is dependent on conformation, and the next several years will see increased interest in the conformational analysis of these polymers resulting from the development of biosimilar or "e;follow-on"e; biological products.
A Single Source on Parallel Synthesis for Lead OptimizationThe end of the previous millennium saw an explosion in the application of parallel synthesis techniques for making compounds for high-throughput screening.
This book comprehensively reviews the diverse potential of microbial enzymes with therapeutic applications, covering their production, purification, and utilization.
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.
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.
The biopharmaceutical industry has entered an era of unprecedented change and challenge, characterized by increasing pricing pressures, rising rates of attrition in the product development lifecycle, and decreasing scientific innovation.
