Drug Drug Interactions for Therapeutic Biologics

Author: Honghui Zhou
Publisher: John Wiley & Sons
ISBN: 1118630211
Format: PDF, ePub, Docs
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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.

ADME and Translational Pharmacokinetics Pharmacodynamics of Therapeutic Proteins

Author: Honghui Zhou
Publisher: John Wiley & Sons
ISBN: 1118898648
Format: PDF, Mobi
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"This book focuses on the fundamental and practical aspects of ADME and translational PK/PD for therapeutic proteins -- cutting-edge research, lessons learned from small molecules, the utility of ADME and translational PK/PD to guide lead optimization, first-in-human study dose projection and design, and clinical development and registration"--Provided by publisher.

Proteins and Peptides

Author: Randall J. Mrsny
Publisher: CRC Press
ISBN: 1420078070
Format: PDF
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Addressing the increased use of protein and peptide candidates as treatments for previously untreatable diseases, this comprehensive and progressive source provides the reader with a roadmap to an increased understanding of issues critical for successfully developing a protein or peptide therapeutic candidate. Proteins and Peptides is an invaluable source for drug discovery and development scientists in the biopharmaceutical industry who frequently navigate the maze of protein and peptide pharmacokinetics, pharmacodynamics, and metabolism. Key features include:

Pharmacokinetics and Pharmacodynamics of Biotech Drugs

Author: Bernd Meibohm
Publisher: John Wiley & Sons
ISBN: 3527609520
Format: PDF, ePub
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This first ever coverage of the pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals meets the need for a comprehensive book in this field. It spans all topics from lead identification right up to final-stage clinical trials. Following an introduction to the role of PK and PD in the development of biotech drugs, the book goes on to cover the basics, including the pharmacokinetics of peptides, monoclonal antibodies, antisense oligonucleotides, as well as viral and non-viral gene delivery vectors. The second section discusses such challenges and opportunities as pulmonary delivery of proteins and peptides, and the delivery of oligonucleotides. The final section considers the integration of PK and PD concepts into the biotech drug development plan, taking as case studies the preclinical and clinical drug development of tasidotin, as well as the examples of cetuximab and pegfilgrastim. The result is vital reading for all pharmaceutical researchers.

Enzyme and Transporter Based Drug Drug Interactions

Author: K. Sandy Pang
Publisher: Springer Science & Business Media
ISBN: 9781441908407
Format: PDF
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Germination of the thought of "Enzymatic- and Transporter-Based Drug-Drug Interactions: Progress and Future Challenges" Proceedings came about as part of the annual meeting of The American Association of Pharmaceutical Scientists (AAPS) that was held in San Diego in November of 2007. The attendance of workshop by more than 250 pharmaceutical scientists reflected the increased interest in the area of drug-drug interactions (DDIs), the greater focus of PhRMA, academia, and regulatory agencies, and the rapid pace of growth in knowledge. One of the aims of the workshop was to address the progress made in quantitatively predicting enzyme- and transporter-based DDIs as well as highlighted areas where such predictions are poor or areas that remain challenging for the future. Because of the serious clinical implications, initiatives have arisen from the FDA (http://www.fda.gov/cber/gdlns/interactstud.htm) to highlight the importance of enzyme- and transporter-based DDIs. During the past ten to fifteen years, we have come to realize that transporters, in addition to enzymes, play a vital role in drug elimination. Such insight has been possible because of the continued growth in PK-ADME (pharmacokinetics-absorption-distribution-metabolism-excretion) knowledge, fueled by further advances in molecular biology, greater availability of human tissues, and the development of additional and sophisticated model systems and sensitive assay methods for studying drug metabolism and transport in vitro and in vivo. This has sparked an in-depth probing into mechanisms surrounding DDIs, resulting from ligand-induced changes in nuclear receptors, as well as alterations in transporter and enzyme expression and function. Despite such advances, the in vitro and in vivo study of drug interactions and the integration of various data sets remain challenging. Therefore, it has become apparent that a proceeding that serves to encapsulate current strategies, approaches, methods and applications is necessary. As Editors, we have assembled a number of opinion leaders and asked them to contribute chapters surrounding these issues. Many of these are the original Workshop speakers whereas others had been selected specially to contribute on topics related to basic and applied information that had not been covered in other reference texts on DDI. The resulting tome, entitled Enzyme- and Transporter-Based Drug Interactions: Progress and Future Challenges, comprises of four sections. Twenty-eight chapters covering various topics and perspectives related to the subject of metabolic and transporter-based drug-drug interactions are presented.

Translational Bioinformatics and Systems Biology Methods for Personalized Medicine

Author: Qing Yan
Publisher: Academic Press
ISBN: 0128043881
Format: PDF, Mobi
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Translational Bioinformatics and Systems Biology Methods for Personalized Medicine introduces integrative approaches in translational bioinformatics and systems biology to support the practice of personalized, precision, predictive, preventive, and participatory medicine. Through the description of important cutting-edge technologies in bioinformatics and systems biology, readers may gain an essential understanding of state-of-the-art methodologies. The book discusses topics such as the challenges and tasks in translational bioinformatics; pharmacogenomics, systems biology, and personalized medicine; and the applicability of translational bioinformatics for biomarker discovery, epigenomics, and molecular dynamics. It also discusses data integration and mining, immunoinformatics, and neuroinformatics. With broad coverage of both basic scientific and clinical applications, this book is suitable for a wide range of readers who may not be scientists but who are also interested in the practice of personalized medicine. Introduces integrative approaches in translational bioinformatics and systems biology to support the practice of personalized, precision, predictive, preventive, and participatory medicine Presents a problem-solving oriented methodology to deal with practical problems in various applications Covers both basic scientific and clinical applications in order to enhance the collaboration between researchers and clinicians Brings integrative and multidisciplinary approaches to bridge the gaps among various knowledge domains in the field

Drug Interactions in Infectious Diseases

Author: Stephen C. Piscitelli
Publisher: Springer Science & Business Media
ISBN: 1592599249
Format: PDF, ePub, Mobi
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Over the past 25 years, the world’s population has witnessed an explosion in kno- edge about infectious diseases. The global population is coming to the realization that diseases long recognized to cause substantial suffering, such as malaria, tuberculosis, schistosomiasis, and hepatitis, can be diagnosed and treated, and that transmission can be prevented using tools that are available, and which may be becoming increasingly affordable. The global population is recognizing that few infections are local: the travel of humans, other animals, insects, and food transport pathogens around the world, often with astonishing rapidity. New pathogens are appearing, either newly recognized or newly developing, such as severe acute respiratory syndrome (SARS), avian inf- enza, metapneumovirus, or hepatitis C, which are causing human morbidity and m- tality. Finally, there is growing fear that dangerous pathogens may be intentionally introduced into human populations by deranged individuals or terrorist organizations. The potential to use drugs or biologic agents to treat and prevent infectious diseases has increased dramatically over the past quarter century as we have learned more about the biology of many of these agents, and as we have developed techniques to discover new agents by high throughput screening programs and by sophisticated drug design and synthesis.

Pharmacokinetics and Pharmacodynamics of Biotech Drugs

Author: Bernd Meibohm
Publisher: John Wiley & Sons
ISBN: 3527609520
Format: PDF
Download Now
This first ever coverage of the pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals meets the need for a comprehensive book in this field. It spans all topics from lead identification right up to final-stage clinical trials. Following an introduction to the role of PK and PD in the development of biotech drugs, the book goes on to cover the basics, including the pharmacokinetics of peptides, monoclonal antibodies, antisense oligonucleotides, as well as viral and non-viral gene delivery vectors. The second section discusses such challenges and opportunities as pulmonary delivery of proteins and peptides, and the delivery of oligonucleotides. The final section considers the integration of PK and PD concepts into the biotech drug development plan, taking as case studies the preclinical and clinical drug development of tasidotin, as well as the examples of cetuximab and pegfilgrastim. The result is vital reading for all pharmaceutical researchers.

Preventing Medication Errors

Author: Committee on Identifying and Preventing Medication Errors
Publisher: National Academies Press
ISBN: 0309101476
Format: PDF, Docs
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In 1996 the Institute of Medicine launched the Quality Chasm Series, a series of reports focused on assessing and improving the nation's quality of health care. Preventing Medication Errors is the newest volume in the series. Responding to the key messages in earlier volumes of the series-To Err Is Human (2000), Crossing the Quality Chasm (2001), and Patient Safety (2004)-this book sets forth an agenda for improving the safety of medication use. It begins by providing an overview of the system for drug development, regulation, distribution, and use. Preventing Medication Errors also examines the peer-reviewed literature on the incidence and the cost of medication errors and the effectiveness of error prevention strategies. Presenting data that will foster the reduction of medication errors, the book provides action agendas detailing the measures needed to improve the safety of medication use in both the short- and long-term. Patients, primary health care providers, health care organizations, purchasers of group health care, legislators, and those affiliated with providing medications and medication- related products and services will benefit from this guide to reducing medication errors.

Rheumatology E Book

Author: Marc C. Hochberg
Publisher: Elsevier Health Sciences
ISBN: 0702063037
Format: PDF, ePub, Docs
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Stay current in the ever-changing discipline of rheumatology with clear, reliable guidance from Hochberg’s Rheumatology, one of the most respected and trusted sources in the field. Designed to meet the needs of the practicing clinician, this medical reference book provides extensive, authoritative coverage of rheumatic diseases from basic scientific principles to practical points of clinical management in a lucid, logical, user-friendly manner. Track disease progression and treat patients more effectively with the information on genetic findings, imaging outcomes, cell and biologic therapies, rheumatoid arthritis, and SLE. Incorporate recent findings about pathogenesis of disease; imaging outcomes for specific diseases like RA, osteoarthritis, and spondyloarthropathies; cell and biologic therapies; and other timely topics. Remain up to date on the latest information in rheumatology through 13 brand-new chapters covering biomedical and translation science, disease and outcome assessment, new imaging modalities, early emerging disease, clinical therapeutics, patient management, and rehabilitation. Take advantage of expanded coverage of small molecule treatment, biologics, biomarkers, epigenetics, biosimilars, and cell-based therapies. Focus on the core knowledge needed for successful results with each chapter co-authored by an internationally-renowned specialist in the field. Easily find the information you need thanks to a consistent, user-friendly format with templated content and large-scale images.