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Inhaled Pharmaceutical Product Development Perspectives

Inhaled Pharmaceutical Product Development Perspectives
Challenges and Opportunities

by Anthony J. Hickey

  • Publisher : Elsevier
  • Release : 2017-11-23
  • Pages : 110
  • ISBN : 0128123362
  • Language : En, Es, Fr & De
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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

Pharmaceutical Drug Product Development and Process Optimization

Pharmaceutical Drug Product Development and Process Optimization
Effective Use of Quality by Design

by Sarwar Beg,Majed Al Robaian,Mahfoozur Rahman,Syed Sarim Imam,Nabil Alruwaili,Sunil Kumar Panda

  • Publisher : CRC Press
  • Release : 2020-05-01
  • Pages : 354
  • ISBN : 1000731324
  • Language : En, Es, Fr & De
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Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.

The Mechanics of Inhaled Pharmaceutical Aerosols

The Mechanics of Inhaled Pharmaceutical Aerosols
An Introduction

by Warren H. Finlay

  • Publisher : Elsevier
  • Release : 2001-06-19
  • Pages : 320
  • ISBN : 0080511376
  • Language : En, Es, Fr & De
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The Mechanics of Inhaled Pharmaceutical Aerosols, An Introduction provides a unique and comprehensive treatment of the mechanics of inhaled pharmaceutical aerosols. The book covers a wide range of topics and many new perspectives are given by drawing on research from a variety of fields. Novel, in-depth expositions of the most common delivery devices are given, including nebulizers, dry powder inhalers and propellant metered dose inhalers. The behaviour of aerosols in the respiratory tract is explained in detail, with complete coverage of the fundamentals of current deposition models. The book begins by providing a comprehensive introduction to aspects of aerosol mechanics that are relevant to inhaled pharmaceutical aerosols. It then gives an exhaustive pedagogical description of the behaviour of evaporating and condensing droplets (both aqueous and propellant-based), an introductory chapter on lung geometry and inhalation patterns, and coverage of relevant aspects of fluid mechanics in the lung. Finally, the book provides invaluable, detailed coverage on the mechanics of common pharmaceutical aerosol delivery systems and deposition in the respiratory tract. Throughout the book are many detailed numerical examples that apply the salient concepts to typical inhaled pharmaceutical aerosols. This book will be of interest to scientists and engineers involved in the research and development of inhaled pharmaceutical aerosol products. Experienced practitioners will find many new perspectives that will greatly enhance their understanding of this complex and rapidly growing field. For those delivering therapeutic agents to the lung, this book is a must-have. Students and academics will find this book an invaluable tool and for newcomers it is a worthy guide to the diverse fields that must be understood to work in the area of inhaled pharmaceutical aerosols.

Pharmaceutical Inhalation Aerosol Technology, Third Edition

Pharmaceutical Inhalation Aerosol Technology, Third Edition
A Book

by Anthony J. Hickey,Sandro R. da Rocha

  • Publisher : CRC Press
  • Release : 2019-03-26
  • Pages : 730
  • ISBN : 0429619561
  • Language : En, Es, Fr & De
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This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to treat symptoms or the underlying causes of disease. It focuses on the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery. The expanded scope considers previously unaddressed aspects of pharmaceutical inhalation aerosol technology and the patient interface by including aerosol delivery, lung deposition and clearance that are used as measures of effective dose delivery.

Smokeless Tobacco Products

Smokeless Tobacco Products
Characteristics, Usage, Health Effects, and Regulatory Implications

by Anonim

  • Publisher : Elsevier
  • Release : 2020-01-23
  • Pages : 240
  • ISBN : 0128181591
  • Language : En, Es, Fr & De
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Smokeless Tobacco Products: Characteristics, Usage, Health Effects, and Regulatory Implications, a title in the Emerging Issues in Analytical Chemistry series, presents an overview of research on the second most dangerous tobacco product. This book presents findings on public health risks emanating from the complex interaction between smokeless tobacco products and their users. It covers the key components of assessment and provides insight into scientific and public health considerations. The book does not take a simplistic condemnatory position, but rather conceptualizes tobacco use in terms of graduated public health danger and harm reduction. The book begins by introducing smokeless tobacco, its history of use, marketing, and implications for public health. It then continues with coverage of epidemiology, pathology and clinical implications, addiction, and treatment, and includes laboratory studies of human use. The following section explains the chemistry, biochemical mechanisms of carcinogenesis, and role of plant cultivation and manufacturing in toxicity. Finally, the book concludes by addressing regulatory considerations, the scientific basis of regulations, and the role of these products in harm reduction for smokers. This is the first resource of its kind to cover these topics together and in language appropriate to both specialists in the research community and informed persons responsible for legislative, funding, and public health matters in the community at large. Brings attention to smokeless tobacco product use and its association with addiction and disease Considers smokeless tobacco use historically and currently, as well as its place in a future harm-reduction conceptualization of tobacco Written by a distinguished, internationally recognized group of tobacco researchers from academia, independent research organizations, and the federal government with expertise in the many and various disciplines covered

Inhaled Medicines

Inhaled Medicines
Optimizing Development through Integration of In Silico, In Vitro and In Vivo Approaches

by Stavros Kassinos,Per Bäckman,Joy Conway,Anthony J. J. Hickey

  • Publisher : Academic Press
  • Release : 2021-01-20
  • Pages : 438
  • ISBN : 0128149752
  • Language : En, Es, Fr & De
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Inhaled medicines are widely used to treat pulmonary and systemic diseases. The efficacy and safety of these medicines can be influenced by the deposited fraction, the regional deposition pattern within the lungs and by post-depositional events such as drug dissolution, absorption and clearance from the lungs. Optimizing performance of treatments thus requires that we understand and are able to quantify these product and drug attributes. Inhaled Medicines: Optimizing Development through Integration of In Silico, In Vitro and In Vivo Approaches explores the current state of the art with respect to inhalation drug delivery, technologies available to assess product performance, and novel in silico methods now available to link in vitro product performance to clinical performance. Recent developments in the latter field, especially the prospect of integration of three-dimensional Computational Fluid Particle Methods (3D-CFPD) with physiologically based pharmacokinetic (PBPK models), unlocks the potential for in silico population studies that can help inform and optimize treatment and product development strategies. In this highly multidisciplinary field, where progress occurs at the intersection of several disciplines of engineering and science, this work aims to integrate current knowledge and understanding and to articulate a clear vision for future developments. ● Considers the healthcare needs driving the field, and where inhaled drugs could have the maximum impact ● Gives a concise account of the state of the art in key areas and technologies such as device and formulation technologies, clinically relevant in vitro performance assessment, medical imaging, as well as in silico modelling and simulation ● Articulates how the combination of in vitro product performance data, medical imaging and simulations technologies in the framework of large scale in silico pre-clinical trials could revolutionize the field ● Provides systematic and thorough referencing to sources offering a more-in-depth analysis of technical issues

Design of Experiments for Pharmaceutical Product Development

Design of Experiments for Pharmaceutical Product Development
Volume II : Applications and Practical Case studies

by Sarwar Beg

  • Publisher : Springer Nature
  • Release : 2021-01-22
  • Pages : 188
  • ISBN : 9813343516
  • Language : En, Es, Fr & De
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This book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development. It discusses the applications of experimental designs that shall include oral, topical, transdermal, injectables preparations, and beyond for nanopharmaceutical product development, leading to dedicated case studies on various pharmaceutical experiments through illustrations, art-works, tables and figures. This book is a valuable guide for all academic and industrial researchers, pharmaceutical and biomedical scientists, undergraduate and postgraduate research scholars, pharmacists, biostatisticians, biotechnologists, formulations and process engineers, regulatory affairs and quality assurance personnel.

Leachables and Extractables Handbook

Leachables and Extractables Handbook
Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

by Douglas J. Ball,Daniel L. Norwood,Cheryl L. M. Stults,Lee M. Nagao

  • Publisher : John Wiley & Sons
  • Release : 2012-02-08
  • Pages : 700
  • ISBN : 1118147685
  • Language : En, Es, Fr & De
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A practical and science-based approach for addressingtoxicological concerns related to leachables and extractablesassociated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal DrugProducts (OINDP)—such as metered dose inhalers, dry powderinhalers, and nasal sprays—pose potential safety risks fromleachables and extractables, chemicals that can be released ormigrate from these components into the drug product. Addressing theconcepts, background, historical use, and development of safetythresholds and their utility for qualifying leachables andextractables in OINDP, the Leachables and Extractables Handbooktakes a practical approach to familiarize readers with the recentrecommendations for safety and risk assessment established througha joint effort of scientists from the FDA, academia, and industry.Coverage includes best practices for the chemical evaluation andmanagement of leachables and extractables throughout thepharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify andrisk-assess container closure system leachables and extractables indrug products Principles for defining toxicological safety thresholds that areapplicable to OINDP and potentially applicable to other drugproducts Regulatory perspectives, along with an appendix of key terms anddefinitions, case studies, and sample protocols Analytical chemists, packaging and device engineers, formulationdevelopment scientists, component suppliers, regulatory affairsspecialists, and toxicologists will all benefit from the wealth ofinformation offered in this important text.

Developing Drug Products in an Aging Society

Developing Drug Products in an Aging Society
From Concept to Prescribing

by Sven Stegemann

  • Publisher : Springer
  • Release : 2016-10-20
  • Pages : 771
  • ISBN : 3319430998
  • Language : En, Es, Fr & De
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This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population. With authors coming from key “aging” markets such as Europe, the USA, China and Japan, the book will provide valuable information for students, scientists, regulators, practitioners, and other healthcare professionals from academia, industry and regulatory bodies.

Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products

Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products
A Book

by Terrence P. Tougas,Jolyon P. Mitchell,Svetlana A. Lyapustina

  • Publisher : Springer Science & Business Media
  • Release : 2013-04-10
  • Pages : 442
  • ISBN : 1461462967
  • Language : En, Es, Fr & De
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The purpose of this publication is to introduce a new, simpler and more effective way in which to interpret pharmaceutical aerosol particle size data from orally inhaled products (OIPs). Currently, the compendial and regulatory requirements dictate the need for measurements by full resolution multi-stage cascade impactor (CI), a process that is demanding for the operator, time consuming, prone to experimental error, and challenging for method transfers from one laboratory to another. Furthermore, we shall show that the current practice of reducing information from mass-weighted aerodynamic particle size distribution (APSD) measurements through the use of CI stage groupings is not the most effective decision-making tool for OIP quality control (QC) in comparison with newly introduced, mutually-independent efficient data analysis (EDA) metrics that can be derived either from full resolution or abbreviated impactor measurements (AIM).

Development of Biopharmaceutical Drug-Device Products

Development of Biopharmaceutical Drug-Device Products
A Book

by Feroz Jameel,John W. Skoug,Robert R. Nesbitt

  • Publisher : Springer Nature
  • Release : 2020-03-13
  • Pages : 893
  • ISBN : 3030314154
  • Language : En, Es, Fr & De
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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.

New Scientist

New Scientist
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2004
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Generic Drug Product Development

Generic Drug Product Development
Specialty Dosage Forms

by Leon Shargel,Isadore Kanfer

  • Publisher : CRC Press
  • Release : 2016-04-19
  • Pages : 288
  • ISBN : 142002003X
  • Language : En, Es, Fr & De
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Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products. The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.

Pharmaceutical Product Development

Pharmaceutical Product Development
Insights Into Pharmaceutical Processes, Management and Regulatory Affairs

by Vandana B. Patravale,John I. Disouza,Maharukh Rustomjee

  • Publisher : CRC Press
  • Release : 2016-05-25
  • Pages : 433
  • ISBN : 1498730787
  • Language : En, Es, Fr & De
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Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.

Inhalation Toxicology

Inhalation Toxicology
A Book

by Harry Salem,Sidney A. Katz

  • Publisher : CRC Press
  • Release : 2005-12-22
  • Pages : 1056
  • ISBN : 1420037307
  • Language : En, Es, Fr & De
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Written by internationally recognized scientists from academic, industrial, and governmental sectors, Inhalation Toxicology, Second Edition details the methods and materials used in the theoretical and applied aspects of inhalation toxicology. The editors emphasize the relationship between the respiratory system and toxicology of inhaled substances and examine methods and measurements for improving our understanding of the basic mechanisms of effects. The book delineates key issues in the field such as regulatory aspects of exposure and testing, testing equipment and methods, biomarkers, pathology, allergies and immunology, irritation of the respiratory tract, and risk assessment. It covers the inhalation of bioaerosols and toxins, ranging from anthrax to household molds as well as genomics, proteomics, and low-level exposure toxicants such as tobacco smoke and chemical warfare agents. Highlights include coverage of the Acute Exposure Guidelines and Emergence Response Guidelines and recent changes in the European and American guidelines for testing procedures. The book focuses on key issues associated with airborne substances and provides critical reviews of the latest advances. Presenting sophisticated concepts in a readable, accessible format, the book distills the latest information into practical knowledge.

Generic Drug Product Development

Generic Drug Product Development
Bioequivalence Issues

by Isadore Kanfer,Leon Shargel

  • Publisher : CRC Press
  • Release : 2008
  • Pages : 264
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.

Pharmaceutical Inhalation Aerosol Technology, Second Edition

Pharmaceutical Inhalation Aerosol Technology, Second Edition
A Book

by Anthony J. Hickey

  • Publisher : CRC Press
  • Release : 2003-09-03
  • Pages : 288
  • ISBN : 9780824756642
  • Language : En, Es, Fr & De
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This thoroughly revised and expanded reference provides authoritative discussions on the physiologic, pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosol. It analyzes the latest science and developments in the generation, administration and characterization of these compounds, showcasing current clinical applications, the efficiency and limitations of major aerosol products and emerging aerosol therapies impacting the field.

Kona

Kona
Powder and Particle

by Anonim

  • Publisher : Unknown Publisher
  • Release : 2008
  • Pages : 329
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Colloid and Interface Science in Pharmaceutical Research and Development

Colloid and Interface Science in Pharmaceutical Research and Development
A Book

by Hiroyuki Ohshima,Kimiko Makino

  • Publisher : Elsevier
  • Release : 2014-07-23
  • Pages : 532
  • ISBN : 0444626085
  • Language : En, Es, Fr & De
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Colloid and Interface Science in Pharmaceutical Research and Development describes the role of colloid and surface chemistry in the pharmaceutical sciences. It gives a detailed account of colloid theory, and explains physicochemical properties of the colloidal-pharmaceutical systems, and the methods for their measurement. The book starts with fundamentals in Part I, covering fundamental aspects of colloid and interface sciences as applied to pharmaceutical sciences and thus should be suitable for teaching. Parts II and III treat applications and measurements, and they explains the application of these properties and their influence and use for the development of new drugs. Provides a clear description of the fundamentals of colloid and interface science relevant to drug research and development Explains the physicochemical/colloidal basis of pharmaceutical science Lists modern experimental characterization techniques, provides analytical equations and explanations on analyzing the experimental data Describes the most advanced techniques, AFM (Atomic Force Microscopy), SFA (Surface Force Apparatus) in detail

Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems

Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems
A Book

by Ashok Katdare,Mahesh Chaubal

  • Publisher : CRC Press
  • Release : 2006-07-28
  • Pages : 452
  • ISBN : 9781420004137
  • Language : En, Es, Fr & De
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To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new excipients to be developed and approved continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge new avenues for regulatory review and allowance to use. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.