Through the use of practical examples and solutions, Pharmaceutical Statistics: Practical and Clinical Applications, Fifth Edition provides the most complete and comprehensive guide to the various statistical applications and research issues in the pharmaceutical industry, particularly in clinical trials and bioequivalence studies.
Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing.
Advances in genomics and combinatorial chemistry during the past two decades inspired innovative technologies and changes in the discovery and pre-clinical development paradigm with the goal of accelerating the process of bringing therapeutic drugs to market.
Reflecting the versatility of the author's science and the depth of his experience, Application of Solution Protein Chemistry to Biotechnology explores key contributions that protein scientists can make in the development of products that are both important and commercially viable, and provides them with tools and information required for successfu
Using clear and practical examples, Polymorphism of Pharmaceutical Solids, Second Edition presents a comprehensive examination of polymorphic behavior in pharmaceutical development that is ideal for pharmaceutical development scientists and graduate students in pharmaceutical science.
Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals.
Building upon the foundation of basics discussed in the previous edition, the Second Edition provides a more in-depth look at the latest methods and technologies of advanced drug screening, an essential function of drug discovery.
Design Principles and Analysis Techniques for HRQoL Clinical TrialsSAS, R, and SPSS examples realistically show how to implement methods Focusing on longitudinal studies, Design and Analysis of Quality of Life Studies in Clinical Trials, Second Edition addresses design and analysis aspects in enough detail so that readers can apply statistical meth
In order to understand drug metabolism at its most fundamental level, pharmaceutical scientists must be able to analyze drug compound structures and predict possible metabolic pathways in order to avoid the risk of adverse reactions that lead to the withdrawal of a drug from the market.
Highlighting the latest activities and initiatives of prominent organizations working in the vaccine industry such as the Bill and Melinda Gates Foundation, The Global Alliance for Vaccines and Immunization, WHO, UNICEF, the World Bank, New Generation Vaccines, Fourth Edition, details steps developing countries have taken toward research, development, manufacture, and regulation of several new vaccines for widespread use.
This unique new text delivers a solid foundation for understanding the role of genomics in human health and in advances that promise to help improve the quality of human life.
Using time-to-event analysis methodology requires careful definition of the event, censored observation, provision of adequate follow-up, number of events, and independence or "e;noninformativeness"e; of the censoring mechanisms relative to the event.
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.
The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area.
Optimize Your Chemical DatabaseDesign and Use of Relational Databases in Chemistry helps programmers and users improve their ability to search and manipulate chemical structures and information, especially when using chemical database "e;cartridges"e;.
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.
Volume 1 of this two-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies.
The development of suitable assays, the integration of appropriate technology, and the effective management of the essential infrastructure are all critical to the success of any high-throughput screening (HTS) endeavor.
Applies the Principles of Informatics to the Pharmacy ProfessionEmphasizes Evidence-Based Practice and Quality Improvement ApproachesLeading the way in the integration of information technology with healthcare, Pharmacy Informatics reflects some of the rapid changes that have developed in the pharmacy profession.
Being that pharmacokinetics (PK) is the study of how the body handles various substances, it is not surprising that PK plays an important role in the early development of new drugs.
This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting.
This two volume Second Edition describes the anatomical, physiological, pharmaceutical, and technological aspects of delivery routes, found in areas like:OralOcularDermal and transdermalVaginalColonicOral mucosalNasalPulmonaryProviding insight and critical assessment of the many available and emerging modified release drug delivery systems for thei
Since the publication of the bestselling first edition of CRC Desk Reference of Clinical Pharmacology, dramatic discoveries in molecular medicine along with rapid technological advances have revolutionized the diagnosis and resulted in new medications to be used in the treatment of a broad range of human diseases.
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.
Encouraged by the medicinal success of quinine, early 19th century scientists hoped strychnine, another plant alkaloid with remarkable properties, might also become a new weapon against disease.
In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods.
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.
Six Sigma in the Pharmaceutical Industry is the first book to introduce the fundamentals of Six Sigma, examine control chart theory and practice, and explain the concept of variation management and reduction applied specifically to the pharmaceutical industry.
Completely revised text that reflects to emergent trends and cutting-edge advances in pharmaceutical biotechnology, this Third Edition provides a well-balanced framework for understanding every major aspect of pharmaceutical biotechnology, including drug development, production, dosage forms, administration, and therapeutic developments.
This two volume Second Edition describes the anatomical, physiological, pharmaceutical, and technological aspects of delivery routes, found in areas like:Oral Ocular Dermal and transdermal VaginalColonic Oral mucosal Nasal PulmonaryProviding insight and critical assessment of the many available and emerging modified release drug delivery systems fo
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.
Years of extensive investigation into neurophysiology, neurochemistry, and behavioral pharmacology have produced an understanding of antipsychotic medication action that is much more refined than the original dopamine hypothesis.
Neurodegenerative diseases affect millions of people worldwide and are a group of several diseases with distinct pathology, physiology, prevention, and treatment strategies.
The previous edition of Dry Skin and Moisturizers: Chemistry and Function was the first book devoted to all aspects of moisturizers, a subject often given short shrift in dermatology texts.