drug-drug-interactions-for-therapeutic-biologics

Download Book Drug Drug Interactions For Therapeutic Biologics in PDF format. You can Read Online Drug Drug Interactions For Therapeutic Biologics here in PDF, EPUB, Mobi or Docx formats.

Drug Drug Interactions For Therapeutic Biologics

Author : Honghui Zhou
ISBN : 9781118630211
Genre : Medical
File Size : 47. 78 MB
Format : PDF, Kindle
Download : 270
Read : 884

Get This Book


Strategize, plan, and execute comprehensive drug-druginteraction assessments for therapeutic biologics Offering both theory and practical guidance, this book fullyexplores drug-drug interaction assessments for therapeuticbiologics during the drug development process. It draws togetherand analyzes all the latest findings and practices in order topresent our current understanding of the topic and point the way tonew research. Case studies and examples, coupled with expertadvice, enable readers to better understand the complex mechanismsof biologic drug-drug interactions. Drug-Drug Interactions for Therapeutic Biologics featurescontributions from leading international experts in all areas oftherapeutic biologics drug development and drug-drug interactions.The authors' contributions reflect a thorough review and analysisof the literature as well as their own firsthand laboratoryexperience. Coverage includes such essential topics as: Drug-drug interaction risks in combination with small moleculesand other biologics Pharmacokinetic and pharmacodynamic drug-drug interactions In vitro methods for drug-drug interaction assessment andprediction Risk-based strategies for evaluating biologic drug-druginteractions Strategies to minimize drug-drug interaction risk and mitigatetoxic interactions Key regulations governing drug-drug interaction assessments fortherapeutic biologics. Drug-Drug Interactions for Therapeutic Biologics isrecommended for pharmaceutical and biotechnology scientists,clinical pharmacologists, medicinal chemists, and toxicologists. Byenabling these readers to understand how therapeutic biologics mayinteract with other drugs, the book will help them develop safer,more effective therapeutic biologics.

Introduction To Biological And Small Molecule Drug Research And Development

Author : James Samanen
ISBN : 9780128061954
Genre : Science
File Size : 44. 45 MB
Format : PDF, ePub, Docs
Download : 521
Read : 882

Get This Book


Biotechnology has given rise to a broad range of biotherapies or biologics, including biomolecular drugs, vaccines, cell or gene therapies. This chapter focuses on biomolecular drugs, namely monoclonal antibodies (Mabs), cytokines, tissue growth factors and therapeutic proteins. Prior to the US approval of recombinant human insulin in 1982, biomolecular drugs were extracted from natural sources. The tools of molecular biology have dramatically increased the discovery and development of new biopharmaceuticals. The most obvious difference between small-molecule drugs (SMDs) and biomolecular drugs is size, like the difference in weight between a bicycle and a business jet. SMDs and biomolecular drugs are compared in this chapter by structure, molecular weight, preparation, physicochemical properties, and route of administration, as well as distribution, metabolism, serum half-life, dosing regimen, species reactivity, antigenicity & hypersensitivity, clearance mechanisms, drug–drug interactions, and pharmacology. This chapter reviews the differences and similarities in the various stages of drug discovery and development, with respect to cost, probability of success and cycle time. The clinical metrics of overall clinical success rate, stage-related success rate, and clinical cycle time are examined for SMDs and biomolecular drugs. The hybrid class of peptide drugs tends to be equated with biologics, due to their amino acid content and because oral activity is rare. But peptides truly bridge the gap between small molecules and biologics, in terms of physical properties, range of therapy areas and means of production. This chapter summarizes the similarities and differences of peptide drugs with SMDs and biomolecular drugs. The manner in which these agents compare as products with respect to manufacturing and pricing are considered. Two case studies are presented—the antagonists where small-molecule, peptide and Mab agents have competed in the market, and Her2 inhibitors where small-molecule and Mab agents may ultimately synergize as a combination product. Biomolecular drugs have levelled the playing field. All the “big Pharma” companies now have the capacity to develop both types of drugs. Conversely the larger biotech companies are developing the capacity for small-molecule synthesis. Now, with many blockbuster biologics nearing patent expiration, biosimilars are on the way. It's no longer a question of “choose which type”—one will need to know how to discover and develop either type of drug.

Biotechnology And Biopharmaceuticals

Author :
ISBN : 9781118659984
Genre : Science
File Size : 45. 15 MB
Format : PDF, Kindle
Download : 645
Read : 266

Get This Book


Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

Adme And Translational Pharmacokinetics Pharmacodynamics Of Therapeutic Proteins

Author : Honghui Zhou
ISBN : 9781118898642
Genre : Medical
File Size : 32. 16 MB
Format : PDF
Download : 379
Read : 581

Get This Book


"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.

Quantitative Pharmacology And Individualized Therapy Strategies In Development Of Therapeutic Proteins For Immune Mediated Inflammatory Diseases

Author : Honghui Zhou
ISBN : 9781119289227
Genre : Medical
File Size : 76. 28 MB
Format : PDF, ePub, Docs
Download : 173
Read : 568

Get This Book


Thorough Overview Identifies and Addresses Critical Gaps in the Treatment of Several Chronic Diseases With increasing numbers of patients suffering from Immune-Mediated Inflammatory Diseases (IMIDs), and with the increasing reliance on biopharmaceuticals to treat them, it is imperative that researchers and medical practitioners have a thorough understanding of the absorption, distribution, metabolism and excretion (ADME) of therapeutic proteins as well as translational pharmacokinetic/pharmacodynamic (PK/PD) modeling for them. This comprehensive volume answers that need to be addressed. Featuring eighteen chapters from world-renowned experts and opinion leaders in pharmacology, translational medicine and immunology, editors Honghui Zhou and Diane Mould have curated a much-needed collection of research on the advanced applications of pharmacometrics and systems pharmacology to the development of biotherapeutics and individualized treatment strategies for the treatment of IMIDs. Authors discuss the pathophysiology of autoimmune diseases in addition to both theoretical and practical aspects of quantitative pharmacology for therapeutic proteins, current translational medicine research methodologies and novel thinking in treatment paradigm strategies for IMIDs. Other notable features include: • Contributions from well-known authors representing leading academic research centers, specialized contract research organizations and pharmaceutical industries whose pipelines include therapeutic proteins • Chapters on a wide range of topics (e.g., pathophysiology of autoimmune diseases, biomarkers in ulcerative colitis, model-based meta-analysis use in the development of therapeutic proteins) • Case studies of applying quantitative pharmacology approaches to guiding therapeutic protein drug development in IMIDs such as psoriasis, inflammatory bowel disease, multiple sclerosis and lupus Zhou and Mould’s timely contribution to the critical study of biopharmaceuticals is a valuable resource for any academic and industry researcher working in pharmacokinetics, pharmacology, biochemistry, or biotechnology as well as the many clinicians seeking the safest and most effective treatments for patients dealing with chronic immune disorders.

Identification And Quantification Of Drugs Metabolites Drug Metabolizing Enzymes And Transporters

Author : Shuguang Ma
ISBN : 9780128200193
Genre : Science
File Size : 55. 83 MB
Format : PDF, Mobi
Download : 399
Read : 438

Get This Book


Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters, Second Edition, is completely updated to provide an overview of the last decade’s numerous advances in analytical technologies for detection and quantification of drugs, metabolites, and biomarkers. This new edition goes beyond LC-MS and features all-new chapters on how to evaluate drug absorption, distribution, metabolism, and excretion, potential for hepatic and renal toxicity, immunogenicity of biotherapeutics and translational tools for predicting human dosage, safety and efficacy of small molecules and biologics. This book will be an important handbook and desk reference for pharmacologists, toxicologists, clinical scientists, and students interested in the fields of pharmacology, biochemistry, and drug metabolism. Four sections in the book with 24 chapters give readers an overview of state-of-the-art techniques for identifying and quantifying drugs, metabolites and biomarkers, including a chapter on new approaches for quantification of enzymes and transporters in different tissues Focuses on the role of drug metabolism enzymes, transporters in disposition and drug-drug interactions, as well as strategies for evaluating drug metabolism and safety using advanced liver and kidney models. Discussions on immunogenicity risks of biologics and their evaluation methods have been included Includes several chapters on advanced translational sciences to predict human dosage, pharmacokinetics and efficacy for small molecules and biotherapeutics All chapters are written by experts with a wide range of practical experience from the industry and academia

Translational Medicine

Author : Robert A. Meyers
ISBN : 9783527336593
Genre : Science
File Size : 24. 36 MB
Format : PDF, ePub, Docs
Download : 519
Read : 236

Get This Book


This reference work gives a compete overview of the different stages of drug development using a translational approach. The book is structured in different parts, following the different stages in drug development. Almost half of the work is dedicated to core of drug discovery using a translational approach, the identification of appropriate targets and screening methods for the identification of compounds interacting with these targets. The rest of book covers the whole downstream pipeline after the identification of lead compounds, such as bioavailability issues, identification of appropriate drug delivery venues, production and scaling issues and preclinical trials. As has been the case with other works in the encyclopedia, the book is made up of long, comprehensive and authoritative chapters, written by outstanding researchers in the field.

Handbook Of Basic And Clinical Ocular Pharmacology And Therapeutics

Author : Sunny Ohia
ISBN : 9780128192924
Genre : Medical
File Size : 57. 17 MB
Format : PDF, ePub, Mobi
Download : 227
Read : 1194

Get This Book


Handbook of Basic and Clinical Ocular Pharmacology and Therapeutics provides a review of the basic anatomy, physiology, biochemistry and pathology of the eye with a focus drug therapy, drug delivery and use of therapeutic medical miniature devices. An understanding of the pharmacological actions of drugs acting on the eye requires the student and health care practitioner to learn additional principles in basic and clinical sciences that are unique to this organ. As a sensory organ, the eye is relatively inaccessible to the systemic circulation due to the blood-vitreous, blood-aqueous and blood-retinal barriers. Consequently, the administration of drugs for therapeutic effects in the eye necessitates an understanding of physico-chemical properties of the molecules and pharmacokinetic principles involved in the access to its site of action via topical, intracameral and intravitreal administration. This book includes information on the general principles of pharmacokinetics and pharmacodynamics of drugs as it pertains to the eye and in combating ocular disorders and diseases. Using a disease-themed approach, the book discusses basic and clinical pharmacological principles involved in the therapy of these diseases including the ocular side effect of systemically-administered drugs, drugs used in ophthalmic surgery and miscellaneous agents, the therapeutic utility of biologics, drug conjugates, combination products, gene and cellular therapy are also covered. Handbook of Basic and Clinical Ocular Pharmacology and Therapeutics is useful as a primary and secondary source of reference for up-to-date information about the pharmacological mechanisms of action, pharmacokinetics, side effects, drug-drug interactions and therapeutic indications of drugs for pharmacologists, pharmaceutical scientists, students in the health care disciplines (nursing, pharmacy, optometry, medical), and practitioners in optometry and ophthalmology. Explains the mechanisms of action, side-effects and therapeutic uses of drugs, biologics, miniature devices, gene and cellular therapies for the eye Provides a comprehensive review of the anatomy, physiology, biochemistry, pharmacology, microbiology, genetics and pathology of parts of the eye involved in drug therapy to combat eye disorders and diseases Explores the pharmacological and clinical basis of drugs, drug conjugates, combination products used in the treatment of anterior and posterior segment diseases

Pharmaceutical Biotechnology

Author : Daan J. A. Crommelin
ISBN : 9783030007102
Genre : Medical
File Size : 31. 86 MB
Format : PDF, Mobi
Download : 212
Read : 1203

Get This Book


This introductory text explains both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use. It serves as a complete one-stop source for undergraduate/graduate pharmacists, pharmaceutical science students, and for those in the pharmaceutical industry. The Fifth Edition completely updates the previous edition, and also includes additional coverage on the newer approaches such as oligonucleotides, siRNA, gene therapy and nanotech and enzyme replacement therapy.

Nursing Drug Handbook 2014

Author : Lippincott Williams & Wilkins
ISBN : 1451186355
Genre : Medical
File Size : 36. 40 MB
Format : PDF, Docs
Download : 437
Read : 777

Get This Book


Find complete monographs for more than 900 generic and nearly 3,000 trade drugs—including essential details on 31 NEW drugs—with important nursing considerations for each and every one in the 34th edition of the Nursing2014 Drug Handbook. The best-selling, original drug handbook for nurses features consistently formatted entries for ease of use that focus on the practical information that nurses need. Each monograph consists of generic and trade names, pronunciation key, pregnancy risk category, pharmacologic class, controlled substance schedule (if applicable), available forms & indications and dosages, administration (with drug incompatibilities for I.V. drugs), action (including tables showing route, onset, peak, duration, and half-life), adverse reactions, interactions, effects on lab test results, contraindications, nursing considerations, and patient teaching. You can also count on Nursing2014 Drug Handbook to tell you unapproved, off-label drug uses so you'll always know why a drug is prescribed. And, this year, be a more confident nurse with fingertip access to … • 31 NEW FDA-approved drugs • NEW complete monographs on combination drugs • NEW! 31 new patient-teaching handouts added to the WebToolkit • NEW! safety information: Risk Evaluation and Mitigation Strategies (REMS) • NEW! Indication & Dosage Appendices--Antidotes; Biologics and blood derivatives • Updated therapeutic and pharmacologic class categories With the safeguards you'll find only in the Nursing2014 Drug Handbook, it's easier than ever to stay current on the 3,209 latest changes to drug information and to avoid even the most common medication errors: • Adjust-a-dose feature for dosage adjustments needed by special populations • Administration guidelines for all appropriate routes • Expanded full-color pill guide containing more drug images than in any previous edition! • Increased coverage of adverse reactions! Includes those that occur with 1% & greater frequency, with special emphasis on life-threatening adverse reactions • Chapters on drug classes, drug safety, drug interactions, and drug therapy across the lifespan • Combination drug section • Elder care medication tips and pediatric drug-error information in appendices • Evidence-based off-label indications and dosages • FDA Black Box Warnings in appropriate drug monographs • Interactions by Drug-drug, Drug-food, Drug-lab tests, Drug-alternative therapy clearly identified • Less Commonly Used Drugs appendix provides essential information, including indications and dosages for very infrequently used drugs • Overdose signs & symptoms, where appropriate • Robust Web Toolkit with hundreds of tools and resources, including monthly drug updates, warnings, and news capsules • Safe Drug Administration chapter focuses on the most current guidelines, ISMP initiatives, and contemporary patient safety issues, such as REMS • Safety alert icon for potentially toxic drugs, I.V. drug incompatibility, dialyzable drugs, toxic drug-drug interactions, and much more.

Adme And Translational Pharmacokinetics Pharmacodynamics Of Therapeutic Proteins

Author : Honghui Zhou
ISBN : 9781118898802
Genre : Medical
File Size : 50. 65 MB
Format : PDF
Download : 967
Read : 860

Get This Book


With an emphasis on the fundamental and practical aspects of ADME for therapeutic proteins, this book helps readers strategize, plan and implement translational research for biologic drugs. • Details cutting-edge ADME (absorption, distribution, metabolism and excretion) and PKPD (pharmacokinetic / pharmacodynamics) modeling for biologic drugs • Combines theoretical with practical aspects of ADME in biologic drug discovery and development and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned perspective • Includes case studies about leveraging ADME to improve biologics drug development for monoclonal antibodies, fusion proteins, pegylated proteins, ADCs, bispecifics, and vaccines • Presents regulatory expectations and industry perspectives for developing biologic drugs in USA, EU, and Japan • Provides mechanistic insight into biodistribution and target-driven pharmacokinetics in important sites of action such as tumors and the brain

Medical Pharmacology And Therapeutics E Book

Author : Derek G. Waller
ISBN : 9780702071904
Genre : Medical
File Size : 76. 44 MB
Format : PDF, ePub
Download : 247
Read : 591

Get This Book


Medical Pharmacology & Therapeutics, now in its fifth edition, offers medical students all they need to know to become safe and effective prescribers. It forms a complete, integrated resource for basic pharmaceutical science, pathophysiology, clinical pharmacology, and therapeutics. The fifth edition has been extensively revised and updated throughout. Key features include: Clear, disease-based approach. Presentation of how drugs are used in clinical practice. Succinct explanations of the major pathogenic mechanisms of each disease and consequent clinical signs and symptoms. Comprehensive reviews of major drug classes relevant to each disease. Structured approach to the principles of disease management – outlining core principles of drug choice and planning a therapeutic regimen for common diseases. Quick-reference drug compendia illustrating key similarities and differences among all BNF-listed drugs in each class. Comes with free e-book on StudentConsult. New sections on key and evolving topics, including prescribing safety and pharmacovigilance. Updated figures to further clarify complex areas. Revised multiple-choice and case-based questions for self-assessment.

Biologics Biosimilars And Biobetters

Author : Iqbal Ramzan
ISBN : 9781119564652
Genre : Medical
File Size : 43. 3 MB
Format : PDF, Docs
Download : 184
Read : 636

Get This Book


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

Drug Interactions In Infectious Diseases

Author : Stephen C. Piscitelli
ISBN : 9781592599240
Genre : Medical
File Size : 65. 30 MB
Format : PDF
Download : 781
Read : 378

Get This Book


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.

Federal Register

Author :
ISBN : UIUC:30112047503617
Genre : Administrative law
File Size : 68. 43 MB
Format : PDF, ePub
Download : 722
Read : 997

Get This Book



Proteins And Peptides

Author : Randall J. Mrsny
ISBN : 9781420078077
Genre : Medical
File Size : 80. 54 MB
Format : PDF, Docs
Download : 473
Read : 686

Get This Book


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

Drug Safety

Author : Source Wikipedia
ISBN : 1230607129
Genre :
File Size : 35. 34 MB
Format : PDF, Mobi
Download : 657
Read : 596

Get This Book


Please note that the content of this book primarily consists of articles available from Wikipedia or other free sources online. Pages: 38. Chapters: 2008 Chinese heparin adulteration, Adverse drug reaction, Adverse effects of fluoroquinolones, Biodyl, Biologics Control Act, Chicago Tylenol murders, Closed system drug transfer device, Cutter Laboratories, David Graham (epidemiologist), Drugs Controller General of India, Drug recall, Elixir sulfanilamide, EudraVigilance, Institutional review board, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Investigational New Drug, Jim (horse), Jonathan Fishbein, List of drug interactions, List of medicine contamination incidents, Marketing Authorization Application, Naranjo algorithm, National Childhood Vaccine Injury Act, New Drug Application, Over-the-counter drug, Peter Rheinstein, Pharmacovigilance, Qualified Person for Pharmacovigilance, Regulated Product Submissions, Regulation of therapeutic goods, Steroid atrophy, Time temperature indicator, Toxic cough syrup, Vaccine Adverse Event Reporting System, Vaccine court, Vaccine Information Statement, Vaccine Safety Datalink.

Fda S Drug Review Process And The Package Label

Author : Tom Brody
ISBN : 9780128146484
Genre : Business & Economics
File Size : 52. 3 MB
Format : PDF, Kindle
Download : 522
Read : 810

Get This Book


FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label. Reveals strategies for winning FDA approval and for drafting the package label Examples are from one hundred FDA-submissions (NDAs, BLAs) for one hundred different drugs, e.g., for oncology, metabolic diseases, autoimmune diseases, and neurological diseases This book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely, the data from NDAs and BLAs as published on FDA's website at the time FDA grants approval to the drug

A Comprehensive Guide To Toxicology In Preclinical Drug Development

Author : Ali S. Faqi
ISBN : 9780123878168
Genre : Medical
File Size : 32. 47 MB
Format : PDF, ePub
Download : 428
Read : 1075

Get This Book


A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. Chapters written by world-renowned contributors who are experts in their fields Includes the latest research in preclinical drug testing and international guidelines Covers preclinical toxicology in small molecules and biologics in one single source

Biologics And Biosimilars

Author : Xiaodong Feng
ISBN : 9780429939280
Genre : Medical
File Size : 36. 56 MB
Format : PDF, ePub
Download : 536
Read : 315

Get This Book


Biologics and Biosimilars: Drug Discovery and Clinical Applications is a systematic integration and evaluation of all aspects of biologics and biosimilars, encompassing research and development, clinical use, global regulation, and more. Biosimilars are biological therapeutic agents designed to imitate a reference biologic with high similarities in structure, efficacy, and safety, but also with potential clinical effective and cost-efficient options for the manufacturers, payers, clinicians, and patients. Most of the top-selling prescription drugs in the current market are biologics, which have revolutionized the treatment strategies and modalities for life-threatening and/or rare diseases. This book outlines the key processes and challenges in drug development, regulations, and clinical applications of biologics, biosimilars, and even interchangeable biosimilars. Global experts in the field discuss essential categories and prototype drugs of biologics and biosimilars in clinical practice such as allergenics, blood and blood components, cell treatment, gene therapy, recombinant therapeutic proteins or peptides, tissues, and vaccines. Additional features: Integrates the latest bench and bedside evidence of drug development and regulations of biologics and biosimilars Contains key study questions for each chapter to guide the readers, as well as drug charts for all therapeutic applications of biologics and biosimilars Presents detailed schematic illustrations to explain the drug development, clinical trials, regulations, and clinical applications of biologics and biosimilars This book is an invaluable tool for health care professional students, providers, and pharmaceutical and health care industries, as well as the public, providing readers with educational updates about the drug development and clinical affairs of biological medications and their similar drugs.

Top Download:

Best Books