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The Future Of Pharmaceutical Product Development And Research

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The Future of Pharmaceutical Product Development and Research

The Future of Pharmaceutical Product Development and Research Book
Author : Anonim
Publisher : Academic Press
Release : 2020-09-02
ISBN : 0128144556
Language : En, Es, Fr & De

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Book Description :

The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries. Provides an overview of practical information for clinical trials Outlines how to ensure an environment that follows Good Manufacturing Practice (GMP) Examines recent developments and suggests future directions for drug production methods and techniques

The Future of Pharmaceutical Product Development and Research

The Future of Pharmaceutical Product Development and Research Book
Author : Anonim
Publisher : Academic Press
Release : 2020-08-19
ISBN : 0128144564
Language : En, Es, Fr & De

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Book Description :

The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries. Provides an overview of practical information for clinical trials Outlines how to ensure an environment that follows Good Manufacturing Practice (GMP) Examines recent developments and suggests future directions for drug production methods and techniques

Research and Development in the Pharmaceutical Industry A CBO Study

Research and Development in the Pharmaceutical Industry  A CBO Study  Book
Author : Congressional Budget Office
Publisher : Lulu.com
Release : 2022-07-05
ISBN : 1304121445
Language : En, Es, Fr & De

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Book Description :

Download Research and Development in the Pharmaceutical Industry A CBO Study book written by Congressional Budget Office, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

The Future of Drug Discovery

The Future of Drug Discovery Book
Author : Tamas Bartfai,Graham V. Lees
Publisher : Academic Press
Release : 2013-05-18
ISBN : 0124095194
Language : En, Es, Fr & De

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Book Description :

The Future of Drug Discovery: Who decides which diseases to treat? provides a timely and detailed look at the efforts of the pharmaceutical industry and how they relate, or should relate, to societal needs. The authors posit that as a result of increasing risk aversion and accelerated savings in research and development, the industry is not developing drugs for increasingly prevalent diseases, such as Alzheimer’s disease, untreatable pain, antibiotics and more. This book carefully exposes the gap between the medicines and therapies we need and the current business path. By analyzing the situation and discussing prospects for the next decade, the The Future of Drug Discovery is a timely book for all those who care about the development needs for drugs for disease. Provides an in-depth, broad perspective on the crisis in drug industry Exposes the disconnect between what society needs and what the drug companies are working on Analyses and projects over 10 years into the future Explains what it means for scientists and society Determines what is needed to be done to make sure that the industry responds to society's needs, remains commercially attractive and answers the question as to who decides which diseases to treat

The Future of Pharma R D

The Future of Pharma R D Book
Author : Harald Pacl
Publisher : Unknown
Release : 2004
ISBN : 9783000140129
Language : En, Es, Fr & De

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Book Description :

Download The Future of Pharma R D book written by Harald Pacl, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Inhaled Pharmaceutical Product Development Perspectives

Inhaled Pharmaceutical Product Development Perspectives Book
Author : Anthony J. Hickey
Publisher : Elsevier
Release : 2017-11-23
ISBN : 0128123362
Language : En, Es, Fr & De

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Book Description :

Inhaled Pharmaceutical Product Development Perspectives: Challenges and Opportunities describes methods and procedures for consideration when developing inhaled pharmaceuticals, while commenting on product development strategies and their suitability to support regulatory submission. It bridges the gap between the aspirations of scientists invested in new technology development and the requirements that must be met for any new product. The book brings together emerging analytical and inhalation technologies, providing perspectives that illuminate formulation and device design, development, regulatory compliance, and practice. Focusing on underlying scientific and technical principles known to be acceptable from the current regulatory perspective, this monograph will remain useful as a high-level guide to inhaled product development for the foreseeable future. Discusses development strategies and best practices in the context of regulatory requirements Written by a broadly qualified expert drawing on the knowledge and critical opinions of key individuals in the field Includes a foreword by Charles G. Thiel

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Improving and Accelerating Therapeutic Development for Nervous System Disorders Book
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Publisher : National Academies Press
Release : 2014-02-06
ISBN : 0309292492
Language : En, Es, Fr & De

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Book Description :

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.

Medicinal Chemistry with Pharmaceutical Product Development

Medicinal Chemistry with Pharmaceutical Product Development Book
Author : Debarshi Kar Mahapatra,Sanjay Kumar Bharti
Publisher : CRC Press
Release : 2019-02-04
ISBN : 0429947143
Language : En, Es, Fr & De

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Book Description :

This volume focuses on novel therapeutics and strategies for the development of pharmaceutical products, keeping the drug molecule as the central component. It discusses current theoretical and practical aspects of pharmaceuticals for the discovery and development of novel therapeutics for health problems. Explaining the necessary features essential for pharmacological activity, it takes an interdisciplinary approach by including a unique combination of pharmacy, chemistry, and medicine along with clinical aspects. It takes into consideration the therapeutic regulations of the USP along with all the latest therapeutic guidelines put forward by WHO, and the US Food and Drug Administration.

The Changing Economics of Medical Technology

The Changing Economics of Medical Technology Book
Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Release : 1991-02-01
ISBN : 030904491X
Language : En, Es, Fr & De

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Book Description :

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policies--as well as the involvement of numerous government agencies--affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

The Era of Artificial Intelligence Machine Learning and Data Science in the Pharmaceutical Industry

The Era of Artificial Intelligence  Machine Learning  and Data Science in the Pharmaceutical Industry Book
Author : Stephanie K. Ashenden
Publisher : Academic Press
Release : 2021-04-23
ISBN : 0128204494
Language : En, Es, Fr & De

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Book Description :

The Era of Artificial Intelligence, Machine Learning and Data Science in the Pharmaceutical Industry examines the drug discovery process, assessing how new technologies have improved effectiveness. Artificial intelligence and machine learning are considered the future for a wide range of disciplines and industries, including the pharmaceutical industry. In an environment where producing a single approved drug costs millions and takes many years of rigorous testing prior to its approval, reducing costs and time is of high interest. This book follows the journey that a drug company takes when producing a therapeutic, from the very beginning to ultimately benefitting a patient’s life. This comprehensive resource will be useful to those working in the pharmaceutical industry, but will also be of interest to anyone doing research in chemical biology, computational chemistry, medicinal chemistry and bioinformatics. Demonstrates how the prediction of toxic effects is performed, how to reduce costs in testing compounds, and its use in animal research Written by the industrial teams who are conducting the work, showcasing how the technology has improved and where it should be further improved Targets materials for a better understanding of techniques from different disciplines, thus creating a complete guide

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products Book
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Publisher : National Academies Press
Release : 2011-04-03
ISBN : 0309158060
Language : En, Es, Fr & De

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Book Description :

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Basic Fundamentals of Drug Delivery

Basic Fundamentals of Drug Delivery Book
Author : Anonim
Publisher : Academic Press
Release : 2018-11-30
ISBN : 0128179104
Language : En, Es, Fr & De

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Book Description :

Basic Fundamentals of Drug Delivery covers the fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to transform a drug candidate or new chemical entity into a final administrable drug delivery system. The book also covers various approaches involved in optimizing the therapeutic performance of a biomolecule while designing its appropriate advanced formulation. Provides up-to-date information on translating the physicochemical properties of drugs into drug delivery systems Explores how drugs are administered via various routes, such as orally, parenterally, transdermally or through inhalation Contains extensive references and further reading for course and self-study

Advances in Pharma Business Management and Research

Advances in Pharma Business Management and Research Book
Author : Lars Schweizer,Theodor Dingermann,Otto Quintus Russe,Christian Jansen
Publisher : Springer Nature
Release : 2020-02-19
ISBN : 3030359182
Language : En, Es, Fr & De

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Book Description :

This open access book presents a unique collection of practical examples from the field of pharma business management and research. It covers a wide range of topics such as: 'Brexit and its Impact on pharmaceutical Law - Implications for Global Pharma Companies', 'Implementation of Measures and Sustainable Actions to Improve Employee's Engagement', 'Global Medical Clinical and Regulatory Affairs (GMCRA)', and 'A Quality Management System for R&D Project and Portfolio Management in a Pharmaceutical Company'. The chapters are summaries of master’s theses by "high potential" Pharma MBA students from the Goethe Business School, Frankfurt/Main, Germany, with 8-10 years of work experience and are based on scientific know-how and real-world experience. The authors applied their interdisciplinary knowledge gained in 22 months of studies in the MBA program to selected practical themes drawn from their daily business.

A Practical Approach to Pharmaceutical Policy

A Practical Approach to Pharmaceutical Policy Book
Author : Andreas Seiter
Publisher : World Bank Publications
Release : 2010-06-17
ISBN : 9780821383872
Language : En, Es, Fr & De

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Book Description :

This book offers policy makers a hands-on approach, tested in the World Bank’s field work in many countries, for developing policies that improve access to safe, effective medicines in health systems of low- and middle-income economies.

Computer Applications in Pharmaceutical Research and Development

Computer Applications in Pharmaceutical Research and Development Book
Author : Sean Ekins
Publisher : John Wiley & Sons
Release : 2006-07-11
ISBN : 0470037229
Language : En, Es, Fr & De

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Book Description :

A unique, holistic approach covering all functions and phases of pharmaceutical research and development While there are a number of texts dedicated to individual aspects of pharmaceutical research and development, this unique contributed work takes a holistic and integrative approach to the use of computers in all phases of drug discovery, development, and marketing. It explains how applications are used at various stages, including bioinformatics, data mining, predicting human response to drugs, and high-throughput screening. By providing a comprehensive view, the book offers readers a unique framework and systems perspective from which they can devise strategies to thoroughly exploit the use of computers in their organizations during all phases of the discovery and development process. Chapters are organized into the following sections: * Computers in pharmaceutical research and development: a general overview * Understanding diseases: mining complex systems for knowledge * Scientific information handling and enhancing productivity * Computers in drug discovery * Computers in preclinical development * Computers in development decision making, economics, and market analysis * Computers in clinical development * Future applications and future development Each chapter is written by one or more leading experts in the field and carefully edited to ensure a consistent structure and approach throughout the book. Figures are used extensively to illustrate complex concepts and multifaceted processes. References are provided in each chapter to enable readers to continue investigating a particular topic in depth. Finally, tables of software resources are provided in many of the chapters. This is essential reading for IT professionals and scientists in the pharmaceutical industry as well as researchers involved in informatics and ADMET, drug discovery, and technology development. The book's cross-functional, all-phases approach provides a unique opportunity for a holistic analysis and assessment of computer applications in pharmaceutics.

Artificial Intelligence in Drug Discovery

Artificial Intelligence in Drug Discovery Book
Author : Nathan Brown
Publisher : Royal Society of Chemistry
Release : 2020-11-11
ISBN : 1839160543
Language : En, Es, Fr & De

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Book Description :

Following significant advances in deep learning and related areas interest in artificial intelligence (AI) has rapidly grown. In particular, the application of AI in drug discovery provides an opportunity to tackle challenges that previously have been difficult to solve, such as predicting properties, designing molecules and optimising synthetic routes. Artificial Intelligence in Drug Discovery aims to introduce the reader to AI and machine learning tools and techniques, and to outline specific challenges including designing new molecular structures, synthesis planning and simulation. Providing a wealth of information from leading experts in the field this book is ideal for students, postgraduates and established researchers in both industry and academia.

Regulatory Affairs in the Pharmaceutical Industry

Regulatory Affairs in the Pharmaceutical Industry Book
Author : Javed Ali,Sanjula Baboota
Publisher : Academic Press
Release : 2021-11-14
ISBN : 0128222239
Language : En, Es, Fr & De

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Book Description :

Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture Book
Author : Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz
Publisher : John Wiley & Sons
Release : 2017-09-01
ISBN : 1119356172
Language : En, Es, Fr & De

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Book Description :

Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.

Innovation and Marketing in the Pharmaceutical Industry

Innovation and Marketing in the Pharmaceutical Industry Book
Author : Min Ding,Jehoshua Eliashberg,Stefan Stremersch
Publisher : Springer Science & Business Media
Release : 2013-10-31
ISBN : 1461478014
Language : En, Es, Fr & De

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Book Description :

The pharmaceutical industry is one of today’s most dynamic and complex industries, involving commercialization of cutting-edge scientific research, a huge web of stakeholders (from investors to doctors), multi-stage supply chains, fierce competition in the race to market, and a challenging regulatory environment. The stakes are high, with each new product raising the prospect of spectacular success—or failure. Worldwide revenues are approaching $1 trillion; in the U.S. alone, marketing for pharmaceutical products is, itself, a multi-billion dollar industry. In this volume, the editors showcase contributions from experts around the world to capture the state of the art in research, analysis, and practice, and covering the full spectrum of topics relating to innovation and marketing, including R&D, promotion, pricing, branding, competitive strategy, and portfolio management. Chapters include such features as: · An extensive literature review, including coverage of research from fields other than marketing · an overview of how practitioners have addressed the topic · introduction of relevant analytical tools, such as statistics and ethnographic studies · suggestions for further research by scholars and students The result is a comprehensive, state-of-the-art resource that will be of interest to researchers, policymakers, and practitioners, alike.

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access

The Role of NIH in Drug Development Innovation and Its Impact on Patient Access Book
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Board on Health Care Services
Publisher : National Academies Press
Release : 2020-02-27
ISBN : 0309498481
Language : En, Es, Fr & De

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Book Description :

To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.