Drug Drug Interactions for Therapeutic Biologics

Drug Drug Interactions for Therapeutic Biologics

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 ...

Author: Honghui Zhou

Publisher: John Wiley & Sons

ISBN: 9781118630211

Category: Medical

Page: 378

View: 792

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.
Categories: Medical

Introduction to Biological and Small Molecule Drug Research and Development

Introduction to Biological and Small Molecule Drug Research and Development

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.

Author: James Samanen

Publisher: Elsevier Inc. Chapters

ISBN: 9780128061954

Category: Science

Page: 472

View: 704

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.
Categories: Science

Biotechnology and Biopharmaceuticals

Biotechnology and Biopharmaceuticals

The essential single source on drug discovery and biotechnology products—newly revised and updated Since the first edition of Biotechnology and Biopharmaceuticals was published, biotechnology has continued to drive therapeutic product ...

Author:

Publisher: John Wiley & Sons

ISBN: 9781118179796

Category: Science

Page: 744

View: 209

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.
Categories: Science

ADME and Translational Pharmacokinetics Pharmacodynamics of Therapeutic Proteins

ADME and Translational Pharmacokinetics   Pharmacodynamics of Therapeutic Proteins

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, ...

Author: Honghui Zhou

Publisher: John Wiley & Sons

ISBN: 9781118898642

Category: Medical

Page: 476

View: 176

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
Categories: Medical

Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune Mediated Inflammatory Diseases

Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune Mediated Inflammatory Diseases

In 2013, he coedited a book entitled, DrugDrug Interactions for Therapeutic Biologics (Wiley), and in 2015, he coedited a book entitled ADME and Translational Pharmacokinetics/Pharmacodynamics of Therapeutic Proteins (Wiley).

Author: Honghui Zhou

Publisher: John Wiley & Sons

ISBN: 9781119289227

Category: Medical

Page: 496

View: 852

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.
Categories: Medical

Identification and Quantification of Drugs Metabolites Drug Metabolizing Enzymes and Transporters

Identification and Quantification of Drugs  Metabolites  Drug Metabolizing Enzymes  and Transporters

[20] J.I. Lee, L. Zhang, A.Y. Men, L.A. Kenna, S.M. Huang, CYP-mediated therapeutic protein-drug interactions: clinical ... Drug-Drug Interactions for Therapeutic Biologics, John Wiley & Sons, Inc., New Jersey, 2013 (Chapter 13).

Author: Shuguang Ma

Publisher: Elsevier

ISBN: 9780128200193

Category: Science

Page: 708

View: 689

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
Categories: Science

Translational Medicine

Translational Medicine

Molecular Pharmacology and Drug Discovery Robert A. Meyers. 105. 106. 107. 108. 109. 110. 112. 111. ... Drugdrug Interaction for Therapeutic Biologics, John Wiley & Sons, Inc., Hoboken, NJ, pp. 5–37. Huang, S.M., Zhao, H., Lee, J.I., ...

Author: Robert A. Meyers

Publisher: John Wiley & Sons

ISBN: 9783527336593

Category: Science

Page: 1064

View: 478

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.
Categories: Science

Handbook of Basic and Clinical Ocular Pharmacology and Therapeutics

Handbook of Basic and Clinical Ocular Pharmacology and Therapeutics

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.

Author: Sunny Ohia

Publisher: Academic Press

ISBN: 9780128192924

Category: Medical

Page: 673

View: 912

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
Categories: Medical

Pharmaceutical Biotechnology

Pharmaceutical Biotechnology

Clin Pharmacol Ther 61(3):275–291 Sheiner L, Wakefield J (1999) Population modelling in drug development. Stat Methods Med Res 8(3):183–193 Shields RL ... Drug-drug interactions for therapeutics biologics. Wiley, Hoboken Spiekermann GM, ...

Author: Daan J. A. Crommelin

Publisher: Springer

ISBN: 9783030007102

Category: Medical

Page: 653

View: 490

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.
Categories: Medical

ADME and Translational Pharmacokinetics Pharmacodynamics of Therapeutic Proteins

ADME and Translational Pharmacokinetics   Pharmacodynamics of Therapeutic Proteins

The potential for a pharmacokinetic interaction between the biologics and the approved drug/combination therapy will need to be 1. Conduct population PK analysis to evaluate the effect of intrinsic and extrinsic factors on the PK of the ...

Author: Honghui Zhou

Publisher: John Wiley & Sons

ISBN: 9781118898802

Category: Medical

Page: 472

View: 335

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
Categories: Medical