Download or read book Ie Drugs Across Spec written by Goldberg and published by . This book was released on 2005-06 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Ie Drugs Across Spec written by Goldberg and published by . This book was released on 2005-06 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Specification of Drug Substances and Products written by Christopher M. Riley and published by Elsevier. This book was released on 2020-07-23 with total page 696 pages. Available in PDF, EPUB and Kindle. Book excerpt: Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories. Presents a critical assessment of the application of ICH guidelines on method validation and specification setting Written by subject-matter experts involved in the development and application of the guidelines Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction
Download or read book Establishing quality specifications for medicines vaccines and in vitro diagnostics written by World Health Organization and published by World Health Organization. This book was released on 2024-07-10 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Preventing HIV Transmission written by National Research Council and Institute of Medicine and published by National Academies Press. This book was released on 1995-09-14 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume addresses the interface of two major national problems: the epidemic of HIV-AIDS and the widespread use of illegal injection drugs. Should communities have the option of giving drug users sterile needles or bleach for cleaning needs in order to reduce the spread of HIV? Does needle distribution worsen the drug problem, as opponents of such programs argue? Do they reduce the spread of other serious diseases, such as hepatitis? Do they result in more used needles being carelessly discarded in the community? The panel takes a critical look at the available data on needle exchange and bleach distribution programs, reaches conclusions about their efficacy, and offers concrete recommendations for public policy to reduce the spread of HIV/AIDS. The book includes current knowledge about the epidemiologies of HIV/AIDS and injection drug use; characteristics of needle exchange and bleach distribution programs and views on those programs from diverse community groups; and a discussion of laws designed to control possession of needles, their impact on needle sharing among injection drug users, and their implications for needle exchange programs.
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Download or read book Connecting Medical Informatics and Bio informatics written by Rolf Engelbrecht and published by IOS Press. This book was released on 2005 with total page 1052 pages. Available in PDF, EPUB and Kindle. Book excerpt: A variety of topics of bio-informatics, including both medical and bio-medical informatics are addressed by MIE. The main theme in this publication is the development of connections between bio-informatics and medical informatics. Tools and concepts from both disciplines can complement each other.
Download or read book Current Trends in Computational Modeling for Drug Discovery written by Supratik Kar and published by Springer Nature. This book was released on 2023-06-30 with total page 311 pages. Available in PDF, EPUB and Kindle. Book excerpt: This contributed volume offers a comprehensive discussion on how to design and discover pharmaceuticals using computational modeling techniques. The different chapters deal with the classical and most advanced techniques, theories, protocols, databases, and tools employed in computer-aided drug design (CADD) covering diverse therapeutic classes. Multiple components of Structure-Based Drug Discovery (SBDD) along with its workflow and associated challenges are presented while potential leads for Alzheimer’s disease (AD), antiviral agents, anti-human immunodeficiency virus (HIV) drugs, and leads for Severe Fever with Thrombocytopenia Syndrome Virus (SFTSV) disease are discussed in detail. Computational toxicological aspects in drug design and discovery, screening adverse effects, and existing or future in silico tools are highlighted, while a novel in silico tool, RASAR, which can be a major technique for small to big datasets when not much experimental data are present, is presented. The book also introduces the reader to the major drug databases covering drug molecules, chemicals, therapeutic targets, metabolomics, and peptides, which are great resources for drug discovery employing drug repurposing, high throughput, and virtual screening. This volume is a great tool for graduates, researchers, academics, and industrial scientists working in the fields of cheminformatics, bioinformatics, computational biology, and chemistry.
Download or read book The Essentials of GCSE OCR Science for Specification A written by Dorothy Warren and published by Letts and Lonsdale. This book was released on 2006 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt: A revision guide that covers the core content of the OCR Science A (single award) specification, from the Twenty First Century Science Suite.
Download or read book Problems of Drug Dependence written by College on Problems of Drug Dependence (U.S.). Scientific Meeting and published by . This book was released on 1988 with total page 584 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Dissolution Testing Bioavailability and Bioequivalence written by Umesh V. Banakar and published by John Wiley & Sons. This book was released on 2022-01-19 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explore the cutting-edge of dissolution testing in an authoritative, one-stop resource In Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence: Science, Applications, and Beyond, distinguished pharmaceutical advisor and consultant Dr. Umesh Banakar delivers a comprehensive and up-to-date reference covering the established and emerging roles of dissolution testing in pharmaceutical drug development. After discussing the fundamentals of the subject, the included resources go on to explore common testing practices and methods, along with their associated challenges and issues, in the drug development life cycle. Over 19 chapters and 1100 references allow practicing scientists to fully understand the role of dissolution, apart from mere quality control. Readers will discover a wide range of topics, including automation, generic and biosimilar drug development, patents, and clinical safety. This volume offers a one-stop resource for information otherwise scattered amongst several different regulatory regimes. It also includes: A thorough introduction to the fundamentals and essential applications of pharmaceutical dissolution testing Comprehensive explorations of the foundations and drug development applications of bioavailability and bioequivalence Practical discussions about solubility, dissolution, permeability, and classification systems in drug development In-depth examinations of the mechanics of dissolution, including mathematical models and simulations An elaborate assessment of biophysiologically relevant dissolution testing and IVIVCs, and their unique applications A complete understanding of the methods, requirements, and global regulatory expectations pertaining to dissolution testing of generic drug products Ideal for drug product development and formulation scientists, quality control and assurance professionals, and regulators, Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence is also the perfect resource for intellectual property assessors.
Download or read book Problems of Drug Dependence 1988 written by Committee on Problems of Drug Dependence (U.S.). Scientific Meeting and published by . This book was released on 1988 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Bayesian Adaptive Design for Immunotherapy and Targeted Therapy written by Haitao Pan and published by Springer Nature. This book was released on 2023-04-19 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive review of novel adaptive trial designs for targeted therapies and immunotherapies. This book covers a wide range of novel statistical designs for various clinical settings, including early phase dose-escalation study, proof-of-concept trials, and confirmatory studies with registrational. The book includes real-life examples and software to facilitate practitioners to learn and use the designs in practice.
Download or read book Problems of Drug Dependence written by and published by . This book was released on with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Poorly Soluble Drugs written by Gregory K. Webster and published by CRC Press. This book was released on 2017-01-06 with total page 578 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Such drug products are, vis-à-vis their physical and chemical properties, inherently incompatible with aqueous dissolution. However, dissolution methods are required for product development and selection, as well as for the fulfillment of regulatory obligations with respect to biopharmaceutical assessment and product quality understanding. The percentage of poorly soluble drugs, defined in classes 2 and 4 of the Biopharmaceutics Classification System (BCS), has significantly increased in the modern pharmaceutical development pipeline. This book provides a thorough exposition of general method development strategies for such drugs, including instrumentation and media selection, the use of compendial and non-compendial techniques in product development, and phase-appropriate approaches to dissolution development. Emerging topics in the field of dissolution are also discussed, including biorelevant and biphasic dissolution, the use on enzymes in dissolution testing, dissolution of suspensions, and drug release of non-oral products. Of particular interest to the industrial pharmaceutical professional, a brief overview of the formulation and solubilization techniques employed in the development of BCS class 2 and 4 drugs to overcome solubility challenges is provided and is complemented by a collection of chapters that survey the approaches and considerations in developing dissolution methodologies for enabling drug delivery technologies, including nanosuspensions, lipid-based formulations, and stabilized amorphous drug formulations.
Download or read book Global Competitiveness of U S Advanced technology Manufacturing Industries written by and published by . This book was released on 1991 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Advances in Chromatographic Techniques for Therapeutic Drug Monitoring written by Amitava Dasgupta and published by CRC Press. This book was released on 2009-10-06 with total page 475 pages. Available in PDF, EPUB and Kindle. Book excerpt: For drugs with a narrow therapeutic index, therapeutic drug monitoring methods are essential for patient management. Although immunoassays are commercially available for many drugs and most laboratories use these assays for routine therapeutic monitoring, they have many limitations which hinder their efficacy. Providing practical guidelines for imp
