Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Download or read book Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics written by Lisa M.. Plitnick and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biological Drug Products written by Wei Wang and published by John Wiley & Sons. This book was released on 2013-08-29 with total page 531 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.
Download or read book Expediting Drug and Biologics Development written by Steven E. Linberg and published by . This book was released on 1995-01-01 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biologics Development written by Mark P. Mathieu and published by Parexel International Corporation. This book was released on 1993 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biologics Development written by Mark Mathieu and published by Barnett Educational Services / Chi. This book was released on 2004-01-01 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication is the only text on Biologics Development and Regulation in the Post-CBER/CDER Consolidation Era. Completely revised and updated to address the transfer of therapeutic biological products to CDER, this all-new edition provides the most comprehensive and up-to-date analysis of the FDA's emerging processes for regulating and approving biological products. Written by CDER and CBER officials and industry experts, Biologics Development: A Regulatory Overview offers an expansive examination of the FDA's regulation of biologic products, from preclinical testing to post-marketing regulatory requirements, and from user fees to electronic submissions. Better yet, this new text provides the first detailed look inside the re-invented FDA that will regulate and approve today's biological products.
Download or read book Introduction to Biological and Small Molecule Drug Research and Development written by C. Robin Ganellin and published by Academic Press. This book was released on 2013-05-07 with total page 469 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction to Biological and Small Molecule Drug Research and Development provides, for the first time, an introduction to the science behind successful pharmaceutical research and development programs. The book explains basic principles, then compares and contrasts approaches to both biopharmaceuticals (proteins) and small molecule drugs, presenting an overview of the business and management issues of these approaches. The latter part of the book provides carefully selected real-life case studies illustrating how the theory presented in the first part of the book is actually put into practice. Studies include Herceptin/T-DM1, erythropoietin (Epogen/Eprex/NeoRecormon), anti-HIV protease inhibitor Darunavir, and more. Introduction to Biological and Small Molecule Drug Research and Development is intended for late-stage undergraduates or postgraduates studying chemistry (at the biology interface), biochemistry, medicine, pharmacy, medicine, or allied subjects. The book is also useful in a wide variety of science degree courses, in post-graduate taught material (Masters and PhD), and as basic background reading for scientists in the pharmaceutical industry. - For the first time, the fundamental scientific principles of biopharmaceuticals and small molecule chemotherapeutics are discussed side-by-side at a basic level - Edited by three senior scientists with over 100 years of experience in drug research who have compiled the best scientific comparison of small molecule and biopharmaceuticals approaches to new drugs - Illustrated with key examples of important drugs that exemplify the basic principles of pharmaceutical drug research and development
Download or read book Pharmaco Imaging in Drug and Biologics Development written by Brian R. Moyer and published by Springer Science & Business Media. This book was released on 2013-11-08 with total page 413 pages. Available in PDF, EPUB and Kindle. Book excerpt: The volume aim to be a comprehensive overview of the drug and biologic development process that is often called “the valley of death” (pre-IND through approval) where high costs of studies and high rates of product failure are part of the drug development landscape. Imaging tools can serve in this period by adding high value data, the images and the kinetic information they can provide, and cost-effective development alternative tools which potentially improve pivotal study designs. Imaging may identify safety issues early such as unwanted organ or tissue distributions, and then can serve advanced development with added certainty of a drug or biologic’s success to senior corporate management and investors. There are numerous textbooks, reference texts and treatises on medical imaging technologies, teaching tools on medical cases and physics books on the science of detector and computer interface systems. Rarely, in each of these are examples of medical imaging protocols and animal models of disease i.e. a text on methodology in drug development is currently unavailable.
Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
Download or read book A Comprehensive Guide to Toxicology in Nonclinical Drug Development written by Ali S. Faqi and published by Academic Press. This book was released on 2016-11-03 with total page 988 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more Updated with the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology
Download or read book Drug and Biological Development written by Ronald P. Evens and published by Springer Science & Business Media. This book was released on 2007-08-14 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers a complete discussion of product development in the pharmaceutical and biotechnology industries from discovery, to product launch, through life cycle management. The book is organized for optimal usefulness in the education and training of health care professionals (MD, PharmD, PhD), at universities. The format is a set of figures, tables and lists, along with detailed narrative descriptions, including real-life examples, illustrations, controversies in industry, and references. The editors and authors of the book are industry and research experts in a variety of disciplines.
Download or read book Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics written by Lisa M. Plitnick and published by Academic Press. This book was released on 2013-06-27 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics. - Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical - Contains the most pertinent international regulatory guidance documents for nonclinical evaluation - Covers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or "biosimilars" - A multi-authored book with chapters written by qualified experts in their respective fields
Download or read book Expediting Drug and Biologics Development written by Steven E. Linberg and published by . This book was released on 1999-12-01 with total page 527 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biologics Biosimilars and Biobetters written by Iqbal Ramzan and published by John Wiley & Sons. This book was released on 2021-02-03 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists
Download or read book Basic Principles of Drug Discovery and Development written by Benjamin E. Blass and published by Academic Press. This book was released on 2021-03-30 with total page 738 pages. Available in PDF, EPUB and Kindle. Book excerpt: Basic Principles of Drug Discovery and Development presents the multifaceted process of identifying a new drug in the modern era, which requires a multidisciplinary team approach with input from medicinal chemists, biologists, pharmacologists, drug metabolism experts, toxicologists, clinicians, and a host of experts from numerous additional fields. Enabling technologies such as high throughput screening, structure-based drug design, molecular modeling, pharmaceutical profiling, and translational medicine are critical to the successful development of marketable therapeutics. Given the wide range of disciplines and techniques that are required for cutting edge drug discovery and development, a scientist must master their own fields as well as have a fundamental understanding of their collaborator's fields. This book bridges the knowledge gaps that invariably lead to communication issues in a new scientist's early career, providing a fundamental understanding of the various techniques and disciplines required for the multifaceted endeavor of drug research and development. It provides students, new industrial scientists, and academics with a basic understanding of the drug discovery and development process. The fully updated text provides an excellent overview of the process and includes chapters on important drug targets by class, in vitro screening methods, medicinal chemistry strategies in drug design, principles of in vivo pharmacokinetics and pharmacodynamics, animal models of disease states, clinical trial basics, and selected business aspects of the drug discovery process. - Provides a clear explanation of how the pharmaceutical industry works, as well as the complete drug discovery and development process, from obtaining a lead, to testing the bioactivity, to producing the drug, and protecting the intellectual property - Includes a new chapter on the discovery and development of biologics (antibodies proteins, antibody/receptor complexes, antibody drug conjugates), a growing and important area of the pharmaceutical industry landscape - Features a new section on formulations, including a discussion of IV formulations suitable for human clinical trials, as well as the application of nanotechnology and the use of transdermal patch technology for drug delivery - Updated chapter with new case studies includes additional modern examples of drug discovery through high through-put screening, fragment-based drug design, and computational chemistry
Download or read book Introduction to Biologic and Biosimilar Product Development and Analysis written by Karen M. Nagel and published by Springer. This book was released on 2018-09-27 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery. In order to maintain a limited focus, Introduction to Biologic and Biosimilar Product Development and Analysis, will deal only with peptides, proteins and monoclonal antibodies.
Download or read book Lyophilized Biologics and Vaccines written by Dushyant Varshney and published by Springer. This book was released on 2015-05-19 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), complex biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate drying technology, to latest regulatory, packaging and technology transfer considerations to develop a stable, safe and effective therapeutic protein, vaccine and biotechnology products. Lyophilized Biologics and Vaccines: Modality-Based Approaches is composed of four sections with a total of 17 chapters. It serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch: Provides recent understanding of heterogeneity of protein environment and selection of appropriate buffer for stabilization of lyophilized formulations Details the latest developments in instrumental analysis and controlled ice nucleation technology Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Details an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspective Provides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies Provides a step-by-step guide through critical considerations during process scale-up, technology transfer, packaging and drug delivery device selection, for a successful lyophilization process validation, regulatory submission and product launch Chapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals. Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development.
