Найти книгу: "Drug-Drug Interactions for Therapeutic Biologics"

Strategize, plan, and execute comprehensive drug-drug interaction assessments for therapeutic biologics Offering both theory and practical guidance, this book fully explores drug-drug interaction assessments for therapeutic biologics during the drug development process. It draws together and analyzes all the latest findings and practices in order to present our current understanding of the topic and point the way to new research. Case studies and examples, coupled with expert advice, enable readers to better understand the complex mechanisms of biologic drug-drug interactions. Drug-Drug Interactions for Therapeutic Biologics features contributions from leading international experts in all areas of therapeutic biologics drug development and drug-drug interactions. The authors' contributions reflect a thorough review and analysis of the literature as well as their own firsthand laboratory experience. Coverage includes such essential topics as: Drug-drug interaction risks in combination with small molecules and other biologics Pharmacokinetic and pharmacodynamic drug-drug interactions In vitro methods for drug-drug interaction assessment and prediction Risk-based strategies for evaluating biologic drug-drug interactions Strategies to minimize drug-drug interaction risk and mitigate toxic interactions Key regulations governing drug-drug interaction assessments for therapeutic biologics. Drug-Drug Interactions for Therapeutic Biologics is recommended for pharmaceutical and biotechnology scientists, clinical pharmacologists, medicinal chemists, and toxicologists. By enabling these readers to understand how therapeutic biologics may interact with other drugs, the book will help them develop safer, more effective therapeutic biologics.

The tools for detecting false positives, false negatives, and interference in interactions when testing and monitoring therapeutic drug use For physicians monitoring a patient's progress, efficacy of treatment is often linked to a patient's response to medication. Determining whether a patient is taking the prescribed amount, the drug or dosage is effective, or the prescribed medication is interacting with other drugs can be determined through drug testing. Written as a guide for toxicologists, chemists, and health professionals involved in patient care, Resolving Erroneous Reports in Toxicology and Therapeutic Drug Monitoring provides an up-to-date introduction to the tests and methodologies used in a toxicology lab as well as the sources of testing error that can lead to false positives, false negatives, and unreliable conclusions of drug abuse or under use. Covering a host of common therapeutic drugs as well as specific types of interference in immunoassays used in drug testing, the book details a number of possible testing scenarios and problems as well as solutions: False positive results in immunoassays for drugs in abuse testing Interferences in immunoassays used for monitoring anticonvulsants, tricyclic antidepressants, and digoxin False positive alcohol tests using breath analyzers and automated analyzers When a toxicology report is negative in a suspected overdose patient: the world of designer drugs Effects of drug-herb interactions on therapeutic drug monitoring Pharmacogenomics and the general principles of genetic analysis Approaches for eliminating interference/discordant specimen in therapeutic drug monitoring and drugs in abuse testing What to do in case there is no readily available method for testing Complete with easy-to-read tables and flowcharts, this book helps toxicologists, clinical chemists, clinical pathologists, and forensic pathologists develop accurate, unbiased drug monitoring and toxicology reports. Health care professionals involved in patient care, especially of critically ill patients, will find this guide indispensable in making sure lab tests are reliable enough to provide high-quality care. An indispensable handbook to the entire suite of toxicology lab tests, as well as all the possible sources of testing error, Resolving Erroneous Reports in Toxicology and Therapeutic Drug Monitoring offers clear remedies for eliminating and preventing testing error.

This book bridges the gap between practitioners of supply-chain management and pharmaceutical industry experts. It aims to help both these groups understand the different worlds they live in and how to jointly contribute to meaningful improvements in supply-chains within the globally important pharmaceutical sector. Scientific and technical staff must work closely with supply-chain practitioners and other relevant parties to help secure responsive, cost effective and risk mitigated supply chains to compete on a world stage. This should not wait until a drug has been registered, but should start as early as possible in the development process and before registration or clinical trials. The author suggests that CMC (chemistry manufacturing controls) drug development must reset the line of sight – from supply of drug to the clinic and gaining a registration, to the building of a patient value stream. Capable processes and suppliers, streamlined logistics, flexible plant and equipment, shorter cycle times, effective flow of information and reduced waste. All these factors can and should be addressed at the CMC development stage.

This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries.

Therapy and Beyond: Counselling Psychology Contributions to Therapeutic and Social Issues presents an overview of the origins, current practices, and potential future of the discipline of counselling psychology. Presents an up-to-date review of the knowledge base behind the discipline of counselling psychology that addresses the notion of human wellbeing and critiques the concept of ‘psychopathology’ Includes an assessment of the contributions that counselling psychology makes to understanding people as individuals, in their working lives, and in wider social domains Offers an overview of counselling psychology's contributions beyond the consulting room, including practices in the domain of spirituality, the arts and creative media, and the environmental movement Critiques contemporary challenges facing research as well as the role that research methods have in responding to questions about humanity and individual experience

For this ready reference, the internationally renowned authority in the field, Roland Kontermann, has assembled a team of outstanding contributors from industry and academia to convey the worldwide knowledge on modifying therapeutic proteins in order to optimize their pharmacological potential. The result is a comprehensive work covering all approaches and aspects of the topic in one handy volume, making this indispensable reading for companies and research institutions working on the development of biopharmaceuticals.