ADME and Translational Pharmacokinetics   Pharmacodynamics of Therapeutic Proteins Book

ADME and Translational Pharmacokinetics Pharmacodynamics of Therapeutic Proteins

  • Author : Honghui Zhou
  • Publisher : John Wiley & Sons
  • Release Date : 2015-12-02
  • Genre: Medical
  • Pages : 480
  • ISBN 10 : 9781118898642

ADME and Translational Pharmacokinetics Pharmacodynamics of Therapeutic Proteins Excerpt :

"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 Book

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

  • Author : Honghui Zhou
  • Publisher : John Wiley & Sons
  • Release Date : 2019-02-14
  • Genre: Medical
  • Pages : 496
  • ISBN 10 : 9781119289227

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

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 v

Nano Pharmacokinetics and Theranostics Book

Nano Pharmacokinetics and Theranostics

  • Author : Nanasaheb D. Thorat
  • Publisher : Academic Press
  • Release Date : 2021-07-28
  • Genre: Business & Economics
  • Pages : 324
  • ISBN 10 : 9780323859820

Nano Pharmacokinetics and Theranostics Excerpt :

Nano-Pharmacokinetics and Theranostics: Advancing Cancer Therapy addresses from a comprehensive and multidisciplinary approach the translational aspects and clinical perspectives of nano-pharmacokinetics using cancer as a model disease. Nano-pharmacokinetics is emerging as an important sub discipline of nanoscience and medical sciences because of the increasing safety issues of nanosystems on living organisms. This book reports the dynamics of nanosystems in living organisms for better understanding of nanotoxicity, pharmacology, biochemistry, physiology and medicine perspectives. It further examines current progress of state-of-the art pharmacokinetics mechanisms, which will be of great help to develop more clinical-oriented nanosystems with a wide safety margin. The book is divided into three sections: the first section focuses on the concept of pharmacokinetics with state-of-the-art Nano-Pharmacokinetics (NPK). The second section looks at the engineering of nanoparticles and pharmacokinetics clinical development. The final section focuses on Nano-Pharmacokinetics and Theranostics, elaborating the basic question of how pharmacokinetics of nanomaterials relate to their end applications such as cancer therapy. Nano-Pharmacokinetics and Theranostics: Advancing Cancer Therapy will be useful to researchers in the field of nanoparticle based targeted drug delivery including pharmaceutical scientists, material scientists, chemists, nanotechnologists, biomedical scientists, and clinicians. Includes contributions from highly qualified scientists, regulatory entities, enterprises and medical practitioners to explain the long and inherently multidisciplinary pathway of nano-pharmacokinetics Describes assessment methods of nano-pharmacokinetics Examines the interface between nanomedicine and pharmacokinetics to diagnose and treat cancer

Biologics  Biosimilars  and Biobetters Book

Biologics Biosimilars and Biobetters

  • Author : Iqbal Ramzan
  • Publisher : John Wiley & Sons
  • Release Date : 2021-02-03
  • Genre: Medical
  • Pages : 320
  • ISBN 10 : 9781119564652

Biologics Biosimilars and Biobetters 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

Drug Metabolism in Diseases Book

Drug Metabolism in Diseases

  • Author : Wen Xie
  • Publisher : Academic Press
  • Release Date : 2016-09-12
  • Genre: Medical
  • Pages : 294
  • ISBN 10 : 9780128029633

Drug Metabolism in Diseases Excerpt :

Drug Metabolism in Diseases is a comprehensive reference devoted to the current state of research on the impact of various disease states on drug metabolism. The book contains valuable insights into mechanistic effects and examples of how to accurately predict drug metabolism during these different pathophysiological states. Each chapter clearly presents the effects of changes in drug metabolism and drug transporters on pharmacokinetics and disposition. This is a unique and useful approach for all those involved in drug discovery and development, and for clinicians and researchers in drug metabolism, pharmacology, and clinical pharmacology. Written and edited by leaders in drug metabolism from academia and industry Covers important topics, such as pharmacogenomics, drug metabolism in transplant patients, xenobiotic receptors, drug metabolism in geriatric and pediatric populations, and more Highlights topics of importance in drug discovery and development, and for safe and effective drug use in the clinic

Basic Principles of Drug Discovery and Development Book

Basic Principles of Drug Discovery and Development

  • Author : Benjamin E. Blass
  • Publisher : Academic Press
  • Release Date : 2021-03-30
  • Genre: Medical
  • Pages : 712
  • ISBN 10 : 9780128172155

Basic Principles of Drug Discovery and Development 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 conjugate

Translational Medicine Book

Translational Medicine

  • Author : Joy A. Cavagnaro
  • Publisher : CRC Press
  • Release Date : 2021-11-26
  • Genre: Medical
  • Pages : 542
  • ISBN 10 : 9781000471823

Translational Medicine Excerpt :

Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety. Key Features: Defines best practices for leveraging of discovery research to facilitate a development program Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications Discusses rare diseases Discusses "What-Why-When-How" highlighting different considerations based upon product attributes. Includes special considerations for rare diseases About the Editors Joy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies. Mary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the bio

Remington Book


  • Author : Adeboye Adejare
  • Publisher : Academic Press
  • Release Date : 2020-11-03
  • Genre: Business & Economics
  • Pages : 1030
  • ISBN 10 : 9780128223895

Remington Excerpt :

Remington: The Science and Practice of Pharmacy, Twenty Third Edition, offers a trusted, completely updated source of information for education, training, and development of pharmacists. Published for the first time with Elsevier, this edition includes coverage of biologics and biosimilars as uses of those therapeutics have increased substantially since the previous edition. Also discussed are formulations, drug delivery (including prodrugs, salts, polymorphism. With clear, detailed color illustrations, fundamental information on a range of pharmaceutical science areas, and information on new developments in industry, pharmaceutical industry scientists, especially those involved in drug discovery and development will find this edition of Remington an essential reference. Intellectual property professionals will also find this reference helpful to cite in patents and resulting litigations. Additional graduate and postgraduate students in Pharmacy and Pharmaceutical Sciences will refer to this book in courses dealing with medicinal chemistry and pharmaceutics. Contains a comprehensive source of principles of drug discovery and development topics, especially for scientists that are new in the pharmaceutical industry such as those with trainings/degrees in chemistry and engineering Provides a detailed source for formulation scientists and compounding pharmacists, from produg to excipient issues Updates this excellent source with the latest information to verify facts and refresh on basics for professionals in the broadly defined pharmaceutical industry

Basic Pharmacokinetics and Pharmacodynamics Book

Basic Pharmacokinetics and Pharmacodynamics

  • Author : Sara E. Rosenbaum
  • Publisher : John Wiley & Sons
  • Release Date : 2016-11-22
  • Genre: Medical
  • Pages : 576
  • ISBN 10 : 9781119143161

Basic Pharmacokinetics and Pharmacodynamics Excerpt :

Updated with new chapters and topics, this book provides a comprehensive description of all essential topics in contemporary pharmacokinetics and pharmacodynamics. It also features interactive computer simulations for students to experiment and observe PK/PD models in action. • Presents the essentials of pharmacokinetics and pharmacodynamics in a clear and progressive manner • Helps students better appreciate important concepts and gain a greater understanding of the mechanism of action of drugs by reinforcing practical applications in both the book and the computer modules • Features interactive computer simulations, available online through a companion website at: • Adds new chapters on physiologically based pharmacokinetic models, predicting drug-drug interactions, and pharmacogenetics while also strengthening original chapters to better prepare students for more advanced applications • Reviews of the 1st edition: “This is an ideal textbook for those starting out … and also for use as a reference book …." (International Society for the Study of Xenobiotics) and “I could recommend Rosenbaum’s book for pharmacology students because it is written from a perspective of drug action . . . Overall, this is a well-written introduction to PK/PD …. “ (British Toxicology Society Newsletter)

Drug Discovery and Development Book

Drug Discovery and Development

  • Author : Vishwanath Gaitonde
  • Publisher : BoD – Books on Demand
  • Release Date : 2020-03-11
  • Genre: Medical
  • Pages : 164
  • ISBN 10 : 9781789239751

Drug Discovery and Development Excerpt :

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.

Improving and Accelerating Therapeutic Development for Nervous System Disorders Book

Improving and Accelerating Therapeutic Development for Nervous System Disorders

  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release Date : 2014-02-06
  • Genre: Medical
  • Pages : 118
  • ISBN 10 : 9780309292498

Improving and Accelerating Therapeutic Development for Nervous System Disorders Excerpt :

Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Applied Clinical Pharmacokinetics and Pharmacodynamics of Psychopharmacological Agents Book

Applied Clinical Pharmacokinetics and Pharmacodynamics of Psychopharmacological Agents

  • Author : Michael W. Jann
  • Publisher : Springer
  • Release Date : 2016-03-02
  • Genre: Medical
  • Pages : 601
  • ISBN 10 : 9783319278834

Applied Clinical Pharmacokinetics and Pharmacodynamics of Psychopharmacological Agents Excerpt :

This book is a comprehensive resource on psychotropic medications, detailing the latest methods for defining their characteristics, their use in different patient populations, and drug-drug interactions; an important collection of information forclinicians, students, researchers, and members of the pharmaceutical industry alike. The first section provides the foundational principles of these drugs. Mathematical modeling of parameters that affect their entryto,and exit from, the central nervous system (CNS) compartment are presented on an individual basis and then applied to target populations with specific disease states. Methods and characteristics that inform the transfer of these drugs from the laboratory bench to use in patient care are discussed, including imaging techniques, genetics and physiological barriers, such as the blood-brain barrier. The second section describes the characteristics of specific agents,nominally arranged intodifferent therapeutic categories and with reference crossover use in different disease states. The pharmacologic characteristics of different drug formulations are explored in the context of their ability to improve patient adherence. The third section focuses on drug-drug interactions.Psychotropic medications from different categories are frequently prescribed together,or alongside medications used to treat comorbid conditions, and the information provided is directly relevant to the clinic, as a result. The clinical application of pharmacokinetics and pharmacodynamics of CNS agents has made significant progress over the past 50 years and new information is reported by numerous publications in psychiatry, neurology, and pharmacology.Our understanding of the interrelationship between these medications, receptors, drug transporters, as well as techniques for measurement and monitoring their interactions,isfrequently updated. However, with information presented on a host of different platforms, and in different formats, obtaining the

Pharmacokinetics and Pharmacodynamics of Biotech Drugs Book
Score: 4
From 1 Ratings

Pharmacokinetics and Pharmacodynamics of Biotech Drugs

  • Author : Bernd Meibohm
  • Publisher : John Wiley & Sons
  • Release Date : 2006-12-13
  • Genre: Science
  • Pages : 426
  • ISBN 10 : 9783527609529

Pharmacokinetics and Pharmacodynamics of Biotech Drugs Excerpt :

This first ever coverage of the pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals meets the need for a comprehensive book in this field. It spans all topics from lead identification right up to final-stage clinical trials. Following an introduction to the role of PK and PD in the development of biotech drugs, the book goes on to cover the basics, including the pharmacokinetics of peptides, monoclonal antibodies, antisense oligonucleotides, as well as viral and non-viral gene delivery vectors. The second section discusses such challenges and opportunities as pulmonary delivery of proteins and peptides, and the delivery of oligonucleotides. The final section considers the integration of PK and PD concepts into the biotech drug development plan, taking as case studies the preclinical and clinical drug development of tasidotin, as well as the examples of cetuximab and pegfilgrastim. The result is vital reading for all pharmaceutical researchers.

Developability of Biotherapeutics Book

Developability of Biotherapeutics

  • Author : Sandeep Kumar
  • Publisher : CRC Press
  • Release Date : 2015-11-18
  • Genre: Medical
  • Pages : 297
  • ISBN 10 : 9781482246155

Developability of Biotherapeutics Excerpt :

Biopharmaceuticals are emerging as frontline medicines to combat several life-threatening and chronic diseases. However, such medicines are expensive to develop and produce on a commercial scale, contributing to rising healthcare costs. Developability of Biotherapeutics: Computational Approaches describes applications of computational and molecular modeling techniques that improve the overall process of discovery and development by removing empiricism. The concept of developability involves making rational choices at the pre-clinical stages of biopharmaceutical drug development that could positively impact clinical outcomes. The book also addresses a general lack of awareness of the many different contributions that computation can make to biopharmaceutical drug development. This informative and practical reference is a valuable resource for professionals engaged in industrial research and development, scientists working with regulatory agencies, and pharmacy, medicine, and life science students and educators. It focuses primarily on the developability of monoclonal antibody candidates, but the principles described can also be extended to other modalities such as recombinant proteins, fusion proteins, antibody drug conjugates and vaccines. The book is organized into two sections. The first discusses principles and applications of computational approaches toward discovering and developing biopharmaceutical drugs. The second presents best practices in developability assessments of early-stage biopharmaceutical drug candidates. In addition to raising awareness of the promise of computational research, this book also discusses solutions required to improve the success rate of translating biologic drug candidates into products available in the clinic. As such, it is a rich source of information on current principles and practices as well as a starting point for finding innovative applications of computation towards biopharmaceutical drug development.

Evaluation of Drug Candidates for Preclinical Development Book

Evaluation of Drug Candidates for Preclinical Development

  • Author : Chao Han
  • Publisher : John Wiley & Sons
  • Release Date : 2010-01-06
  • Genre: Medical
  • Pages : 304
  • ISBN 10 : 0470574887

Evaluation of Drug Candidates for Preclinical Development Excerpt :

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 evaluatio