Advances In Drug Discovery And Quality Evaluation
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Advances In Drug Discovery And Quality Evaluation
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Author : Xuetao Xu
language : en
Publisher: Frontiers Media SA
Release Date : 2023-11-24
Advances In Drug Discovery And Quality Evaluation written by Xuetao Xu and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-24 with Medical categories.
Drug discovery and quality evaluation are very important for human health. Drugs from chemical synthesis and natural products are a very important branch in drug discovery. The highly efficient synthetic methodology development and pharmacological evaluation of related active agents, as essential steps to developing corresponding innovative drugs, are always research frontiers for organic chemists and medicinal chemists. Meanwhile, the drug quality evaluation is an important guarantee for the clinical application of drugs and the efficacy of drugs. Therefore, we wanted to organize this article collection for the presentation of the high-quality work from internationally recognized researchers to promote academic communication among scientific researchers focusing on medicinal and pharmaceutical chemistry. In recent years, the research community has witnessed significant advances in the development of the discovery of novel natural products, design and synthesis of bioactive molecules, synthetic methodology, and drug quality evaluation. Therefore, we hope to be able to summarize and display the latest developments in the design and synthesis of bioactive molecules, synthetic methodologies, the discovery of novel natural products, as well as drugs quality evaluation through the collection of this album, and provide new methods and template molecules for the subsequent development of innovative drug molecules.
Drug Discovery And Development
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Author : Vishwanath Gaitonde
language : en
Publisher: BoD – Books on Demand
Release Date : 2020-03-11
Drug Discovery And Development written by Vishwanath Gaitonde and has been published by BoD – Books on Demand this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-03-11 with Medical categories.
The process of drug discovery and development is a complex multistage logistics project spanned over 10-15 years with an average budget exceeding 1 billion USD. Starting with target identification and synthesizing anywhere between 10k to 15k synthetic compounds to potentially obtain the final drug that reaches the market involves a complicated maze with multiple inter- and intra-operative fields. Topics described in this book emphasize the progresses in computational applications, pharmacokinetics advances, and molecular modeling developments. In addition the book also contains special topics describing target deorphaning in Mycobacterium tuberculosis, therapy treatment of some rare diseases, and developments in the pediatric drug discovery process.
Recent Advances In Drug Discovery And Development
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Author : Lisa Torres
language : en
Publisher: American Medical Publishers
Release Date : 2021-11-16
Recent Advances In Drug Discovery And Development written by Lisa Torres and has been published by American Medical Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-11-16 with Medical categories.
A pharmaceutical drug or a medication is used to diagnose, cure, treat or prevent a disease. Drug therapy depends on the science of pharmacology for research and on pharmacy for proper management. Drug development is the process of identifying a therapeautically useful compound through drug discovery, with the help of which a new drug is brought to the market. It is undertaken by pharmaceutical companies, academic scientists, and governments. Drug discovery and development includes pre-clinical research, clinical trials and obtaining regulatory approval to market the drug. This book contains the different approaches, evaluations, methodologies and advanced studies in the field of drug discovery and development. It is a compilation of chapters that discuss the most vital concepts and emerging trends in the field. This book is a vital tool for all researchers and students in this field.
Quality By Design For Biopharmaceutical Drug Product Development
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Author : Feroz Jameel
language : en
Publisher: Springer
Release Date : 2015-04-01
Quality By Design For Biopharmaceutical Drug Product Development written by Feroz Jameel and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-01 with Medical categories.
This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.
Pet For Drug Development And Evaluation
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Author : D. Comar
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06
Pet For Drug Development And Evaluation written by D. Comar and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Medical categories.
Can drug development and evaluation be improved by the use of positron emission tomography (PET)? PET is now well established and many PET centres participate in networks that warrant the quality of their research. PET allows one to follow the effect of a drug on a variety of patients' metabolic parameters. In addition, PET may be used to follow the fate in vivo of a compound, allowing visualisation of its binding to specific receptors and a direct study of the mechanism of drug action in normal and pathological situations. The book shows the fields in which PET offers new and unique information for the development of drugs (conception, toxicity, pharmacokinetics and metabolism, clinical research, and relations between clinical and biological effects) and evaluates fields in which PET may shorten the development time of drugs. Audience: Professionals in the pharmaceutical industry in all areas of drug discovery and pharmacology, pre-clinical testing, pharmacokinetics and metabolism, clinical evaluation, registration and regulatory affairs. Government health authority representatives who assess data and documentation on new drug development and radiopharmaceuticals. Academic experts concerned with any of these areas.
Evaluation Of Drug Candidates For Preclinical Development
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Author : Chao Han
language : en
Publisher: John Wiley & Sons
Release Date : 2010-01-19
Evaluation Of Drug Candidates For Preclinical Development written by Chao Han and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-01-19 with Medical categories.
Emphasizes the integration of major areas of drug discovery and their importance in candidate evaluation It is believed that selecting the "right" drug candidate for development is the key to success. In the last decade, pharmaceutical R&D departments have integrated pharmacokinetics and drug metabolism, pharmaceutics, and toxicology into early drug discovery to improve the assessment of potential drug compounds. Now, Evaluation of Drug Candidates for Preclinical Development provides a complete view and understanding of why absorption-distribution-metabolism-excretion-toxicology (ADMET) plays a pivotal role in drug discovery and development. Encompassing the three major interrelated areas in which optimization and evaluation of drug developability is most critical—pharmacokinetics and drug metabolism, pharmaceutics, and safety assessment—this unique resource encourages integrated thinking in drug discovery. The contributors to this volume: Cover drug transporters, cytochrome P-450 and drug-drug interactions, plasma protein binding, stability, drug formulation, preclinical safety assessment, toxicology, and toxicokinetics Address developability issues that challenge pharma companies, moving beyond isolated experimental results Reveal connections between the key scientific areas that are critical for successful drug discovery and development Inspire forward-thinking strategies and decision-making processes in preclinical evaluation to maximize the potential of drug candidates to progress through development efficiently and meet the increasing demands of the marketplace Evaluation of Drug Candidates for Preclinical Development serves as an introductory reference for those new to the pharmaceutical industry and drug discovery in particular. It is especially well suited for scientists and management teams in small- to mid-sized pharmaceutical companies, as well as academic researchers and graduate students concerned with the practical aspects related to the evaluation of drug developability.
Pet For Drug Development And Evaluation
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Author : D Comar
language : en
Publisher:
Release Date : 1995-11-30
Pet For Drug Development And Evaluation written by D Comar and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1995-11-30 with categories.
Can drug development and evaluation be improved by the use of positron emission tomography (PET)? PET is now well established and many PET centres participate in networks that warrant the quality of their research. PET allows one to follow the effect of a drug on a variety of patients' metabolic parameters. In addition, PET may be used to follow the fate in vivo of a compound, allowing visualisation of its binding to specific receptors and a direct study of the mechanism of drug action in normal and pathological situations. The book shows the fields in which PET offers new and unique information for the development of drugs (conception, toxicity, pharmacokinetics and metabolism, clinical research, and relations between clinical and biological effects) and evaluates fields in which PET may shorten the development time of drugs. Audience: Professionals in the pharmaceutical industry in all areas of drug discovery and pharmacology, pre-clinical testing, pharmacokinetics and metabolism, clinical evaluation, registration and regulatory affairs. Government health authority representatives who assess data and documentation on new drug development and radiopharmaceuticals. Academic experts concerned with any of these areas.
Drug Discovery And Development Third Edition
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Author : James J. O'Donnell
language : en
Publisher: CRC Press
Release Date : 2019-11-21
Drug Discovery And Development Third Edition written by James J. O'Donnell and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-11-21 with Medical categories.
Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business
International Regulatory Harmonization Amid Globalization Of Drug Development
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2013-11-24
International Regulatory Harmonization Amid Globalization Of Drug Development written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-11-24 with Medical categories.
The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health. To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop.
New Drug Development
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Author : J. Rick Turner
language : en
Publisher: John Wiley & Sons
Release Date : 2007-07-27
New Drug Development written by J. Rick Turner and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-07-27 with Mathematics categories.
This book acquaints students and practitioners in the related fields of pharmaceutical sciences, clinical trials, and evidence-based medicine with the necessary study design concepts and statistical practices to allow them to understand how drug developers plan and evaluate their drug development. Two goals of the book are to make the material accessible to readers with minimal background in research and to be straightforward enough for self-taught purposes. By bringing the topic from the early discovery phase to clinical trials and medical practice, the book provides an indispensable overview of an otherwise confusing and fragmented set of topics. The author’s experience as a respected scientist, teacher of statistics, and one who has worked in the clinical trials arena makes him well suited to write such a treatise.