This book helps readers integrate in silico, in vitro, and in vivo ADMET (absorption, distribution, metabolism, elimination and toxicity) and PK (pharmacokinetics) data with routine testing applications so that pharmaceutical scientists can diagnose ADMET problems and present appropriate recommendations to move drug discovery programs forward.The book introduces the current clinical practice for drug discovery and development along with the impact on early risk as...

With its focus on emerging concerns of kinase and GPCR-mediated antitarget effects, this vital reference for drug developers addresses one of the hot topics in drug safety now and in future.Divided into three major parts, the first section deals with novel technologies and includes the utility of adverse event reports to drug discovery, the translational aspects of preclinical safety findings, broader computational prediction of drug side-effects, and a description of the serotonerg...

According to the Institute of Medicine (IOM) and U.S. Food and Drug Administration (FDA), 'developing new scientific approaches to detecting, understanding, predicting and preventing adverse events' was a critical path to the future of drug safety. This book brings together a collection of state-of-the-art chapters, written by experts in the drug safety field. It provides information on the present knowledge of drug side effects and their mitigation strategy during drug discovery, gives gu...

Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and...

**How genomics, big data, and digital technology are revolutionizing every aspect of medicine, from physical exams to drug prescriptions to organ transplants“The Creative Destruction of Medicine should be required reading by all physicians and in all medical schools. It is simply that good.” —Forbes**Technology dominates our lives, and personal genomics is revolutionizing biology. But despite the availability of technologies that can provide virtual, perso...

In her thesis, Sara Bobone outlines spectroscopic studies of antimicrobial peptides (AMPs) which are promising lead compounds for drugs used to fight multidrug resistant bacteria. Bobone shows that AMPs interact with liposomes and she clarifies the structure of pores formed by one of these molecules. These results help us to understand how AMPs are selective for bacterial membranes and how their activity can be finely tuned by modifying their sequence. Findings which solve several conundru...

The ultimate Canadian guide to prescription medicationOver half of all Canadians take at least one prescription drug, but most of us know very little about the medication we're taking, including why we've been prescribed anything in the first place. Understanding Prescription Drugs Canadians For Dummies will answer many of the questions Canadians have about prescription drugs, but were afraid ask our doctors and pharmacists. Topics covered include:* What a prescription drug ...

As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process.• Guides researchers as to what drug safety experiments are both practical and useful• Covers a variety of key topics – safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and –omics tools•...

The disturbing connection between well-meaning physicians and the prescription drug epidemic.Three out of four people addicted to heroin probably started on a prescription opioid, according to the director of the Centers for Disease Control and Prevention. In the United States alone, 16,000 people die each year as a result of prescription opioid overdose. But perhaps the most frightening aspect of the prescription drug epidemic is that it’s built on well-meaning do...

Animal models play crucial roles in the continuum of experimental activities that make up biomedical research. Such in vivo modes are especially important in proof-of-principle experiments and in establishing the preclinical safety and efficacy data required for progressing to human clinical trials. A practical understanding of the choice, care and use of animal models is thus expected and required of all biomedical researchers. However, while both legislations and the practice of laborato...

Explores the benefits and limitations of the latest high-throughput screening methodsWith its expert coverage of high-throughput in vitro screening methods for toxicity testing, this book makes it possible for researchers to accelerate and streamline the evaluation and risk assessment of chemicals and drugs for toxicity. Moreover, it enables them to comply with the latest standards set forth by the U.S. National Research Council's "Toxicity Testing in the ...

Detailing formulation approaches by stage of discovery to early development, this book gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development.• Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry• Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research