Computational and Experimental Design of Biopharmaceutical Formulations

Computational and Experimental Design of Biopharmaceutical Formulations
Author: Vladimir I. Razinkov,Arnold McAuley,Pavan Ghattyvenkatakrishna,Deirdre Piedmonte
Publsiher: Academic Press
Total Pages: 230
Release: 2021-11-17
ISBN 10: 9780128173480
ISBN 13: 0128173483
Language: EN, FR, DE, ES & NL

Computational and Experimental Design of Biopharmaceutical Formulations Book Review:

Computational and Experimental Design of Biopharmaceutical Formulations outlines available experimental and computational tools. It describes a rational approach to formulation design not limited by experimental design that extends to modern methods of computational modeling. These methods include the modeling of protein structure and dynamics, and of solution properties in the presence of proteins and excipients. The chapters in this book consider computational modeling of protein-solution interactions, the design of early-stage formulation studies, the design of late-stage formulation studies, automation, high-throughput and control, design of lyophilized formulations, and emerging technologies in the future formulation development. Reviews methods for the design of biopharmaceutical formulations Considers both experimental and computational methods in concert Details design techniques specific to each step in protein formulation development Discusses the predictive power of methods used in formulation stability studies Describes and considers the potential of emerging models and experimental technologies

Developability of Biotherapeutics

Developability of Biotherapeutics
Author: Sandeep Kumar,Satish Kumar Singh
Publsiher: CRC Press
Total Pages: 297
Release: 2015-11-18
ISBN 10: 1482246155
ISBN 13: 9781482246155
Language: EN, FR, DE, ES & NL

Developability of Biotherapeutics Book Review:

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.

High Throughput Formulation Development of Biopharmaceuticals

High Throughput Formulation Development of Biopharmaceuticals
Author: Vladimir I. Razinkov,Gerd Kleemann
Publsiher: Woodhead Publishing
Total Pages: 132
Release: 2016-09-29
ISBN 10: 190881876X
ISBN 13: 9781908818768
Language: EN, FR, DE, ES & NL

High Throughput Formulation Development of Biopharmaceuticals Book Review:

High Throughput Formulation Development of Biopharmaceuticals: Practical Guide to Methods and Applications provides the latest developments and information on the science of stable and safe drug product formulations, presenting a comprehensive review and detailed description of modern methodologies in the field of formulation development, a process starting with candidate and pre-formulation screening in its early development phase and then progressing to the refinement of robust formulations during commercialization in the later phases of development. The title covers topics such as experiment design, automation of sample preparation and measurements, high-throughput analytics, stress-inducing methods, statistical analysis of large amounts of formulation study data, emerging technologies, and the presentation of several case studies, along with a concluding summary. Presents applications of high-throughput methodologies to accelerate drug formulation development Provides the latest technologies in the field Includes key statistical approaches, such as design of experiment and multivariate data analysis Written by highly respected formulation development experts

Handbook of Preformulation

Handbook of Preformulation
Author: Sarfaraz K. Niazi
Publsiher: CRC Press
Total Pages: 544
Release: 2019-04-26
ISBN 10: 135158233X
ISBN 13: 9781351582339
Language: EN, FR, DE, ES & NL

Handbook of Preformulation Book Review:

Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development. Entirely focused on preformulation principles, this fully revised and updated Handbook of Preforumulation: Chemical, Biological, and Botanical Drugs, Second Edition provides detailed descriptions of preformulation methodologies, gives a state-of-the-art description of each technique, and lists the currently available tools useful in providing a comprehensive characterization of a new drug entity.

Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Biophysical Characterization of Proteins in Developing Biopharmaceuticals
Author: Damian J. Houde,Steven A. Berkowitz
Publsiher: Elsevier
Total Pages: 586
Release: 2019-11-13
ISBN 10: 0444641742
ISBN 13: 9780444641748
Language: EN, FR, DE, ES & NL

Biophysical Characterization of Proteins in Developing Biopharmaceuticals Book Review:

Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This book will help today’s industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been fully revised, with new chapters focusing on the use of chromatography and electrophoresis and the biophysical characterization of very large biopharmaceuticals. In addition, best practices of applying statistical analysis to biophysical characterization data is included, along with practical issues associated with the concept of a biopharmaceutical’s developability and the technical decision-making process needed when dealing with biophysical characterization data. Presents basic protein characterization methods and tools applicable to (bio)pharmaceutical research and development Highlights the capabilities and limitations of each technique Discusses the underlining science of each tool Empowers industrial biophysical chemists by providing a roadmap for applying biophysical tools Outlines the needs for new characterization and analytical tools in the biopharmaceutical industry

Development of Biopharmaceutical Drug Device Products

Development of Biopharmaceutical Drug Device Products
Author: Feroz Jameel,John W. Skoug,Robert R. Nesbitt
Publsiher: Springer Nature
Total Pages: 893
Release: 2020-03-13
ISBN 10: 3030314154
ISBN 13: 9783030314156
Language: EN, FR, DE, ES & NL

Development of Biopharmaceutical Drug Device Products Book Review:

The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.

Computer Aided Applications in Pharmaceutical Technology

Computer Aided Applications in Pharmaceutical Technology
Author: Jelena Djuris
Publsiher: Elsevier
Total Pages: 300
Release: 2013-04-10
ISBN 10: 1908818328
ISBN 13: 9781908818324
Language: EN, FR, DE, ES & NL

Computer Aided Applications in Pharmaceutical Technology Book Review:

Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially available products. Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods. Simultaneous development and investigation of pharmaceutical products and processes enables application of quality by design concept that is being promoted by the regulatory authorities worldwide. Computer-aided applications in pharmaceutical technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with emphasis of their application in process control, neural computing (artificial neural networks, fuzzy logic and decision trees, evolutionary computing and genetic algorithms, self-organizing maps), computer-aided biopharmaceutical characterization as well as application of computational fluid dynamics in pharmaceutical technology. All of these techniques are essential tools for successful building of quality into pharmaceutical products and processes from the early stage of their development to selection of the optimal ones. In addition to theoretical aspects of various methods, the book provides numerous examples of their application in the field of pharmaceutical technology. A comprehensive review of the current state of the art on various computer aided applications in pharmaceutical technology Case studies are presented in order to facilitate understanding of various concepts in computer-aided applications

Handbook of Industrial Drying

Handbook of Industrial Drying
Author: Arun S. Mujumdar
Publsiher: CRC Press
Total Pages: 1348
Release: 2014-07-11
ISBN 10: 146659666X
ISBN 13: 9781466596665
Language: EN, FR, DE, ES & NL

Handbook of Industrial Drying Book Review:

By far the most commonly encountered and energy-intensive unit operation in almost all industrial sectors, industrial drying continues to attract the interest of scientists, researchers, and engineers. The Handbook of Industrial Drying, Fourth Edition not only delivers a comprehensive treatment of the current state of the art, but also serves as a

Predictive Modeling of Pharmaceutical Unit Operations

Predictive Modeling of Pharmaceutical Unit Operations
Author: Preetanshu Pandey,Rahul Bharadwaj
Publsiher: Woodhead Publishing
Total Pages: 464
Release: 2016-09-26
ISBN 10: 0081001800
ISBN 13: 9780081001806
Language: EN, FR, DE, ES & NL

Predictive Modeling of Pharmaceutical Unit Operations Book Review:

The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included. Explains the commonly used modeling and simulation tools Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing Practical examples of the application of modeling tools through case studies Discussion of modeling techniques used for a risk-based approach to regulatory filings Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points

FOCAPD 19 Proceedings of the 9th International Conference on Foundations of Computer Aided Process Design July 14 18 2019

FOCAPD 19 Proceedings of the 9th International Conference on Foundations of Computer Aided Process Design  July 14   18  2019
Author: Salvador Garcia Munoz,Carl D. Laird,Matthew J. Realff
Publsiher: Elsevier
Total Pages: 530
Release: 2019-07-09
ISBN 10: 0128205717
ISBN 13: 9780128205716
Language: EN, FR, DE, ES & NL

FOCAPD 19 Proceedings of the 9th International Conference on Foundations of Computer Aided Process Design July 14 18 2019 Book Review:

FOCAPD-19/Proceedings of the 9th International Conference on Foundations of Computer-Aided Process Design, July 14 - 18, 2019, compiles the presentations given at the Ninth International Conference on Foundations of Computer-Aided Process Design, FOCAPD-2019. It highlights the meetings held at this event that brings together researchers, educators and practitioners to identify new challenges and opportunities for process and product design. Combines presentations from the Ninth International Conference on Foundations of Computer-Aided Process Design, FOCAPD-2019

Chemical Engineering in the Pharmaceutical Industry

Chemical Engineering in the Pharmaceutical Industry
Author: Mary T. am Ende,David J. am Ende
Publsiher: John Wiley & Sons
Total Pages: 688
Release: 2019-04-08
ISBN 10: 111928550X
ISBN 13: 9781119285502
Language: EN, FR, DE, ES & NL

Chemical Engineering in the Pharmaceutical Industry Book Review:

A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
Author: Feroz Jameel,Susan Hershenson
Publsiher: John Wiley & Sons
Total Pages: 976
Release: 2010-07-13
ISBN 10: 0470595876
ISBN 13: 9780470595879
Language: EN, FR, DE, ES & NL

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals Book Review:

A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Virtual Drug Design

Virtual Drug Design
Author: Daniela Schuster,Honglin Li
Publsiher: Frontiers Media SA
Total Pages: 135
Release: 2020-01-13
ISBN 10: 2889633594
ISBN 13: 9782889633593
Language: EN, FR, DE, ES & NL

Virtual Drug Design Book Review:

In the current drug research environment in academia and industry, cheminformatics and virtual screening methods are well established and integrated tools. Computational tools are used to predict a compound’s 3D structure, the 3D structure and function of a pharmacological target, ligand-target interactions, binding energies, and other factors essential for a successful drug. This includes molecular properties such as solubility, logP value, susceptibility to metabolism, cell permeation, blood brain barrier permeation, interaction with drug transporters and potential off-target effects. Given that approximately 40 million unique compounds are readily available for purchase, such computational modeling and filtering tools are essential to support the drug discovery and development process. The aim of all these calculations is to focus experimental efforts on the most promising candidates and exclude problematic compounds early in the project. In this Research Topic on virtual activity predictions, we cover several aspects of this research area such as historical perspectives, data sources, ligand treatment, virtual screening methods, hit list handling and filtering.

Synthesis Design and Resource Optimization in Batch Chemical Plants

Synthesis  Design  and Resource Optimization in Batch Chemical Plants
Author: Thokozani Majozi,Esmael Reshid Seid,Jui-Yuan Lee
Publsiher: CRC Press
Total Pages: 450
Release: 2015-03-04
ISBN 10: 1482252422
ISBN 13: 9781482252422
Language: EN, FR, DE, ES & NL

Synthesis Design and Resource Optimization in Batch Chemical Plants Book Review:

The manner in which time is captured forms the foundation for synthesis, design, and optimization in batch chemical plants. However, there are still serious challenges with handling time in batch plants. Most techniques tend to assume either a fixed time dimension or adopt time average models to tame the time dimension, thereby simplifying the resu

Water Insoluble Drug Formulation Third Edition

Water Insoluble Drug Formulation  Third Edition
Author: Ron Liu
Publsiher: CRC Press
Total Pages: 736
Release: 2018-03-12
ISBN 10: 1351646826
ISBN 13: 9781351646826
Language: EN, FR, DE, ES & NL

Water Insoluble Drug Formulation Third Edition Book Review:

Properties and Formulation: From Theory to Real-World Application Scientists have attributed more than 40 percent of the failures in new drug development to poor biopharmaceutical properties, particularly water insolubility. Issues surrounding water insolubility can postpone or completely derail important new drug development. Even the much-needed reformulation of currently marketed products can be significantly affected by these challenges. More recently it was reported that the percentage increased to 90% for the candidates of new chemical entities in the discovery stage and 75% for compounds under development. In the most comprehensive resource on the topic, this third edition of Water-Insoluble Drug Formulation brings together a distinguished team of experts to provide the scientific background and step-by-step guidance needed to deal with solubility issues in drug development. Twenty-three chapters systematically describe the detailed discussion on solubility theories, solubility prediction models, the aspects of preformulation, biopharmaceutics, pharmacokinetics, regulatory, and discovery support of water-insoluble drugs to various techniques used in developing delivery systems for water-insoluble drugs. This book includes more than 15 water-insoluble drug delivery systems or technologies, illustrated with case studies and featuring oral and parenteral applications. Highlighting the most current information and data available, this seminal volume reflects the significant progress that has been made in nearly all aspects of this field. The aim of this book is to provide a handy reference for pharmaceutical scientists in the handling of formulation issues related to water-insoluble drugs. In addition, this book may be useful to pharmacy and chemistry undergraduate students and pharmaceutical and biopharmaceutical graduate students to enhance their knowledge in the techniques of drug solubilization and dissolution enhancement.

Molecular Theory of Solutions

Molecular Theory of Solutions
Author: Jens Smiatek
Publsiher: Elsevier
Total Pages: 460
Release: 2022-10-15
ISBN 10: 9780128217443
ISBN 13: 0128217448
Language: EN, FR, DE, ES & NL

Molecular Theory of Solutions Book Review:

Multicomponent solutions with solvents, cosolvents, solutes and ions reveal a plethora of interesting effects. In recent years, the underlying molecular mechanisms have received much attention because they can significantly influence the dynamic and structural properties of solutions on large time and length scales. A deeper understanding of these mechanisms is therefore of fundamental importance for the tailor-made use of liquid formulations. Molecular Theory of Solutions presents basic concepts from modern molecular theories of solutions in order to rationalize the underlying structural and dynamic effects. After a general introduction into the properties of solutions and solvation mechanisms, basic concepts from thermodynamics, statistical mechanics and molecular theories of solutions are reviewed alongside important experimental observations. The book then goes on to discuss basic principles of hydrodynamics and transport theory, with the corresponding outcomes used to highlight various concepts for the theoretical study of effective charge transport, electrokinetic flows and hydrodynamic interactions. The influence of external electric fields in terms of electrokinetic transport, as well as ion correlations, are also highlighted. Basic methods and models for particle-based computer simulation approaches at various length and time scales are then introduced, providing insight into how molecular theories of solutions and simulations can be combined to produce more accurate theories and a more reliable description of solution effects. Drawing on the knowledge of its expert author, Molecular Theory of Solutions is a useful guide to the structural and dynamic properties of solutions for all those working directly or indirectly with soft matter theory, multicomponent and electrolyte solutions, molecular theories of solution, solvation science, dynamic and structural correlations, and the use of computer simulations for the study of these effects. Collates discussion of both dynamic and structural effects in a single volume Highlights contemporary computational approaches and discusses the benefits and drawbacks of novel research tools Provides foundational guidance on solution and solvation science

Dosage Form Design Considerations

Dosage Form Design Considerations
Author: Anonim
Publsiher: Academic Press
Total Pages: 820
Release: 2018-07-28
ISBN 10: 0128144246
ISBN 13: 9780128144244
Language: EN, FR, DE, ES & NL

Dosage Form Design Considerations Book Review:

Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Protein Protein Interactions

Protein Protein Interactions
Author: Krishna Mohan Poluri,Khushboo Gulati,Sharanya Sarkar
Publsiher: Springer Nature
Total Pages: 346
Release: 2021-05-19
ISBN 10: 9811615942
ISBN 13: 9789811615948
Language: EN, FR, DE, ES & NL

Protein Protein Interactions Book Review:

This book provides a comprehensive overview of the fundamental aspects of protein-protein interactions (PPI), including a detailed account of the energetics and thermodynamics involved in these interactions. It also discusses a number of computational and experimental approaches for the prediction of PPI interactions and reviews their principles, advantages, drawbacks, and the recent developments. Further, it offers structural and mechanistic insights into the formation of protein-protein complexes and maps different PPIs into networks to delineate various pathways that operate at the cellular level. Lastly, it describes computational protein-protein docking techniques and discusses their implications for further experimental research. Given its scope, this book is a valuable resource for students, researchers, scientists, entrepreneurs, and medical/healthcare professionals.

Bayesian Analysis with R for Drug Development

Bayesian Analysis with R for Drug Development
Author: Harry Yang,Steven Novick
Publsiher: CRC Press
Total Pages: 310
Release: 2019-07-09
ISBN 10: 1351585932
ISBN 13: 9781351585934
Language: EN, FR, DE, ES & NL

Bayesian Analysis with R for Drug Development Book Review:

Drug development is an iterative process. The recent publications of regulatory guidelines further entail a lifecycle approach. Blending data from disparate sources, the Bayesian approach provides a flexible framework for drug development. Despite its advantages, the uptake of Bayesian methodologies is lagging behind in the field of pharmaceutical development. Written specifically for pharmaceutical practitioners, Bayesian Analysis with R for Drug Development: Concepts, Algorithms, and Case Studies, describes a wide range of Bayesian applications to problems throughout pre-clinical, clinical, and Chemistry, Manufacturing, and Control (CMC) development. Authored by two seasoned statisticians in the pharmaceutical industry, the book provides detailed Bayesian solutions to a broad array of pharmaceutical problems. Features Provides a single source of information on Bayesian statistics for drug development Covers a wide spectrum of pre-clinical, clinical, and CMC topics Demonstrates proper Bayesian applications using real-life examples Includes easy-to-follow R code with Bayesian Markov Chain Monte Carlo performed in both JAGS and Stan Bayesian software platforms Offers sufficient background for each problem and detailed description of solutions suitable for practitioners with limited Bayesian knowledge Harry Yang, Ph.D., is Senior Director and Head of Statistical Sciences at AstraZeneca. He has 24 years of experience across all aspects of drug research and development and extensive global regulatory experiences. He has published 6 statistical books, 15 book chapters, and over 90 peer-reviewed papers on diverse scientific and statistical subjects, including 15 joint statistical works with Dr. Novick. He is a frequent invited speaker at national and international conferences. He also developed statistical courses and conducted training at the FDA and USP as well as Peking University. Steven Novick, Ph.D., is Director of Statistical Sciences at AstraZeneca. He has extensively contributed statistical methods to the biopharmaceutical literature. Novick is a skilled Bayesian computer programmer and is frequently invited to speak at conferences, having developed and taught courses in several areas, including drug-combination analysis and Bayesian methods in clinical areas. Novick served on IPAC-RS and has chaired several national statistical conferences.

Drug Discovery and Development Third Edition

Drug Discovery and Development  Third Edition
Author: James J. O'Donnell,John Somberg,Vincent Idemyor,James T. O'Donnell
Publsiher: CRC Press
Total Pages: 668
Release: 2019-12-13
ISBN 10: 1351625136
ISBN 13: 9781351625135
Language: EN, FR, DE, ES & NL

Drug Discovery and Development Third Edition Book Review:

Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business