Extensively revised and updated, Antisense Drug Technology: Principles, Strategies, and Applications, Second Edition reflects the logarithmic progress made in the past four years of oligonucleotide-based therapies, and, in particular, antisense therapeutics and research.
After 18 years since the first biosimilar was approved, a lot has changed, from the regulatory guidelines to the stakeholder perceptions about the safety and efficacy of biosimilars.
Useful Statistical Approaches for Addressing Multiplicity IssuesIncludes practical examples from recent trials Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, Multiple Testing Problems in Pharmaceutical Statistics explores the rapidly growing area of multiple comparison research with an emphasis on pharmaceutical applications.
Fruit flies are "e;little people with wings"e; goes the saying in the scientific community, ever since the completion of the Human Genome Project and its revelations about the similarity amongst the genomes of different organisms.
Today, more than ever, the pharmacist is a full-member of the health team and many of the pharmacist's patients are using a host of other devices from various specialty areas of medicine and surgery.
The GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry.
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).
The rapid growth of Complementary and Alternative Medicine (CAM) demands that the public, the medical world, social scientists, the media, and governments pay attention.
Drug Delivery Nanosystems for Biomedical Application reviews some of the most challenging nanosystems with different routes of delivery that are useful for specific drugs, from both efficacy and bioavailability points-of-view.
A range of factors must be considered when developing a topical antimicrobial for use in a healthcare personnel handwash, surgical scrub, or preoperative skin preparation.
This class-tested textbook gives an overview of the structure and functions of proteins and explains how amino acids form a defined structural entity with specific properties.
The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation.
After a century of research, several lines of evidence now indicate that the ability of adenosine to directly control inflammatory cells has a major impact on the functions of the inflammatory and immune systems.
The first authoritative overview of past and current strategies for successful drug development by analog generation, this unique resource spans all important drug classes and all major therapeutic fields, including histamine antagonists, ACE inhibitors, beta blockers, opioids, quinolone antibiotics, steroids and anticancer platinum compounds.
This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting.
The concept of the 3Rs (Refinement, Reduction and Replacement) has been used as a framework for improving the welfare of laboratory animals for the last half century.
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.
Furnishing the latest interdisciplinary information on the most important and frequently the only investigational system available for discovery programs that address the effects of small molecules on newly discovered enzyme and receptor targets emanating from molecular biology, this timely resource facilitates the transition from classical to high
Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements.
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.
Carefully crafted to provide tightly focused and authoritative information, the Directory of Therapeutic Enzymes covers all approved therapeutic enzymes currently used in medicine.
Filling a real knowledge gap, this handbook and ready reference is both modern and forward-looking in its emphasis on the "e;bench to bedside"e; translational approach to drug development.
Measures of Interobserver Agreement and Reliability, Second Edition covers important issues related to the design and analysis of reliability and agreement studies.
In recent years, many animal-derived polymers have emerged as an attractive category of naturally derived polymers because of their advantageous physicochemical, chemical, and biological properties.
The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.
Integrated Drug Discovery Technologies provides a global overview of emerging drug development technologies by presenting and integrating new techniques from the disciplines of chemistry, biology, and computational sciences.
The enormous advances in nanomedicine and precision medicine in the past two decades necessitated this comprehensive reference, which can be relied upon by researchers, clinicians, pharmaceutical scientists, regulators, policymakers, and lawyers alike.
Offers essential guidance for discovering and optimizing novel drug therapies Using detailed examples, Evaluation of Enzyme Inhibitors in Drug Discovery equips researchers with the tools needed to apply the science of enzymology and biochemistry to the discovery, optimization, and preclinical development of drugs that work by inhibiting specific enzyme targets.
To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations.