Developing Solid Oral Dosage Forms Book

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Developing Solid Oral Dosage Forms

By Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter
  • ISBN Code: : 9780080932729
  • Publisher : Academic Press
  • Pages : 978
  • Category : Medical
  • Reads : 884
  • Book Compatibility : Pdf, ePub, Mobi, Kindle
  • Pdf : developing-solid-oral-dosage-forms.pdf

Book Excerpt :

Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

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Book Short Summary:

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Book Short Summary:

Absorption, Distribution, Metabolism and Excretion (ADME) processes and their relationship with the design of dosage forms and the success of pharmacotherapy form the basis of this upper level undergraduate/graduate textbook. As an introduction oriented to pharmacy students, it is also written for scientist from different fields outside of pharmaceutics. (e.g. material scientist, material engineers, medicinal chemists) who might be working in a positions in pharmaceutical companies or whose work might benefit from basic training in the ADME concepts and some biological background. Pedagogical features such as objectives, keywords, discussion questions, summaries and case studies add valuable teaching tools. This book will provide not only general knowledge on ADME processes but also an updated insight on some hot topics such as drug transporters, multi-drug resistance related to pharmacokinetic phenomena, last generation pharmaceutical carriers (nanopharmaceuticals), in vitro and in vivo bioequivalence studies, biopharmaceuticals, pharmacogenomics, drug-drug and food-drug interactions, and in silico and in vitro prediction of ADME properties. In comparison with other similar textbooks, around half of the volume would be focused on the relationship between expanding scientific fields and ADME processes. Each of these burgeoning fields has a separate chapter in the second part of the volume, and was written with leading experts on the correspondent topic, including scientists and academics from USA and UK (Duquesne University School of Pharmacy, Indiana University School of Medicine, University of Utah College of Pharmacy, University of Maryland, University of Bath). Additionally, each of the initial chapters dealing with the generalities of drug absorption, distribution, metabolism and excretion would include relevant, classic examples related to each topic with appropriate illustrations (e.g. importance of active absorption of levodopa, implications in levodopa administration, drug drug interactions and food drug interactions emerging from the active uptake; intoxication with paracetamol as a result of glutathione depletion, CYP induction and its relationship with acute liver failure caused by paracetamol, etc). ADME Processes and Pharmaceutical Sciences is written as a core textbook for ADME processes, pharmacy, pharmacokinetics, drug delivery, biopharmaceutics, drug disposition, drug design and medicinal chemistry courses.

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Book Short Summary:

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Book Short Summary:

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

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Book Short Summary:

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.

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Guides readers on the proper use of in vitro drug release methodologies in order to evaluate the performance of special dosage forms In the last decade, the application of drug release testing has widened to a variety of novel/special dosage forms. In order to predict the in vivo behavior of such dosage forms, the design and development of the in vitro test methods need to take into account various aspects, including the dosage form design and the conditions at the site of application and the site of drug release. This unique book is the first to cover the field of in vitro release testing of special dosage forms in one volume. Featuring contributions from an international team of experts, it presents the state of the art of the use of in vitro drug release methodologies for assessing special dosage forms’ performances and describes the different techniques required for each one. In Vitro Drug Release Testing of Special Dosage Forms covers the in vitro release testing of: lipid based oral formulations; chewable oral drug products; injectables; drug eluting stents; inhalation products; transdermal formulations; topical formulations; vaginal and rectal delivery systems and ophthalmics. The book concludes with a look at regulatory aspects. Covers both oral and non-oral dosage forms Describes current regulatory conditions for in vitro drug release testing Features contributions from well respected global experts in dissolution testing In Vitro Drug Release Testing of Special Dosage Forms will find a place on the bookshelves of anyone working with special dosage forms, dissolution testing, drug formulation and delivery, pharmaceutics, and regulatory affairs.

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Book Short Summary:

A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

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Book Short Summary:

This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

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Book Short Summary:

Pharmaceutical Dosage Forms: Capsules covers the development, composition, and manufacture of capsules. Despite the important role that capsules play in drug delivery and product development, few comprehensive texts on the science and technology of capsules have been available for the research and academic environments. This text addresses this gap, discussing how capsules provide unique capabilities and options for dosage form design and formulation.

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Book Short Summary:

Particularly in healthcare fields, there is growing movement away from traditional lecture style course towards active learning and team-based activities to improve learning and build higher level thinking through application of complex problems with a strong foundation of facts and data. Essential Pharmaceutics is suited to this modern teaching style, and is the first book of its kind to provide the resources and skills needed for successful implementation of an active learning pharmaceutics course.This text offers a format that is specifically suited for integration in an active learning, team-based classroom setting. It is ideal for self-learning for the beginning pharmaceutics student, based upon the extensive utilization of figures, tables, and its overview of essential topics in pharmaceutics. Also unique to this text is the integration of case studies based upon modern pharmaceutical products which are designed to reinforce importance pharmaceutical concepts and teach essential skills in literature review and patent searching. Case studies covering all topics covered in the text have been developed by the authors that allow application of the content in the flipped-classroom pharmaceutical course.

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Book Short Summary:

Process Systems Engineering for Pharmaceutical Manufacturing: From Product Design to Enterprise-Wide Decisions, Volume 41, covers the following process systems engineering methods and tools for the modernization of the pharmaceutical industry: computer-aided pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical processing unit operation, integrated flowsheets and applications for design, analysis, risk assessment, sensitivity analysis, optimization, design space identification and control system design; optimal operation, control and monitoring of pharmaceutical production processes; enterprise-wide optimization and supply chain management for pharmaceutical manufacturing processes. Currently, pharmaceutical companies are going through a paradigm shift, from traditional manufacturing mode to modernized mode, built on cutting edge technology and computer-aided methods and tools. Such shifts can benefit tremendously from the application of methods and tools of process systems engineering. Introduces Process System Engineering (PSE) methods and tools for discovering, developing and deploying greener, safer, cost-effective and efficient pharmaceutical production processes Includes a wide spectrum of case studies where different PSE tools and methods are used to improve various pharmaceutical production processes with distinct final products Examines the future benefits and challenges for applying PSE methods and tools to pharmaceutical manufacturing

Sterile Product Development

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Book Short Summary:

This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.

Development and Validation of Analytical Methods

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Book Short Summary:

The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters. Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic. This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.

Chemical Engineering in the Pharmaceutical Industry, Active Pharmaceutical Ingredients

By David J. am Ende,Mary T. am Ende
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : John Wiley & Sons
  • Book Code : 1119285887
  • Total of Pages : 1168
  • Category : Technology & Engineering
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  • Pdf File: chemical-engineering-in-the-pharmaceutical-industry-active-pharmaceutical-ingredients.pdf

Book Short Summary:

A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry is a practical book that highlights chemistry and chemical engineering. The book’s regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition: • Contains 30new chapters or revised chapters specific to API, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety • Expanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying • Presents updated and expanded example calculations • Includes contributions from noted experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of Chemical Engineering in the Pharmaceutical Industry focuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products.

Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms

By Linda A. Felton
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  • Publisher : CRC Press
  • Book Code : 1315352923
  • Total of Pages : 400
  • Category : Medical
  • Members : 514
  • Pdf File: aqueous-polymeric-coatings-for-pharmaceutical-dosage-forms.pdf

Book Short Summary:

Aqueous-based film coating has become routine in the pharmaceutical industry. This process eliminates the use of organic solvents and thus avoids economic, environmental, and toxicological issues related to residual solvents and solvent recovery. Aqueous-based coating, however, is complex and many variables may impact the final product and its performance. This fourth edition of Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms aims to provide insight into the factors and parameters that should be considered and controlled for the successful development and commercialization of a coated product. The fourth edition has been revised and expanded to reflect the most recent scientific advancements from the literature. The contributing authors explain in detail, using illustrated examples, appropriate steps to solve and ideally avoid formulation, processing, and stability problems and to achieve an optimized dosage form. Trade names and chemical names of commercially marketed coatings are used throughout the text to help familiarize the reader with the various materials available for pharmaceutical applications. This book will be a valuable resource for anyone in the pharmaceutical industry working in the area of aqueous-based film coating.

Handbook of Pharmaceutical Manufacturing Formulations

By Sarfaraz K. Niazi
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : CRC Press
  • Book Code : 1420048457
  • Total of Pages : 256
  • Category : Medical
  • Members : 657
  • Pdf File: handbook-of-pharmaceutical-manufacturing-formulations.pdf

Book Short Summary:

The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emul

Amorphous Solid Dispersions

By Navnit Shah,Harpreet Sandhu,Duk Soon Choi,Hitesh Chokshi,A. Waseem Malick
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Springer
  • Book Code : 1493915983
  • Total of Pages : 699
  • Category : Medical
  • Members : 960
  • Pdf File: amorphous-solid-dispersions.pdf

Book Short Summary:

This volume offers a comprehensive guide on the theory and practice of amorphous solid dispersions (ASD) for handling challenges associated with poorly soluble drugs. In twenty-three inclusive chapters, the book examines thermodynamics and kinetics of the amorphous state and amorphous solid dispersions, ASD technologies, excipients for stabilizing amorphous solid dispersions such as polymers, and ASD manufacturing technologies, including spray drying, hot melt extrusion, fluid bed layering and solvent-controlled micro-precipitation technology (MBP). Each technology is illustrated by specific case studies. In addition, dedicated sections cover analytical tools and technologies for characterization of amorphous solid dispersions, the prediction of long-term stability, and the development of suitable dissolution methods and regulatory aspects. The book also highlights future technologies on the horizon, such as supercritical fluid processing, mesoporous silica, KinetiSol®, and the use of non-salt-forming organic acids and amino acids for the stabilization of amorphous systems. Amorphous Solid Dispersions: Theory and Practice is a valuable reference to pharmaceutical scientists interested in developing bioavailable and therapeutically effective formulations of poorly soluble molecules in order to advance these technologies and develop better medicines for the future.

The Brain That Changes Itself

By Norman Doidge
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Penguin
  • Book Code : 1101147113
  • Total of Pages : 448
  • Category : Psychology
  • Members : 762
  • Pdf File: the-brain-that-changes-itself.pdf

Book Short Summary:

“Fascinating. Doidge’s book is a remarkable and hopeful portrait of the endless adaptability of the human brain.”—Oliver Sacks, MD, author of The Man Who Mistook His Wife for a Hat What is neuroplasticity? Is it possible to change your brain? Norman Doidge’s inspiring guide to the new brain science explains all of this and more An astonishing new science called neuroplasticity is overthrowing the centuries-old notion that the human brain is immutable, and proving that it is, in fact, possible to change your brain. Psychoanalyst, Norman Doidge, M.D., traveled the country to meet both the brilliant scientists championing neuroplasticity, its healing powers, and the people whose lives they’ve transformed—people whose mental limitations, brain damage or brain trauma were seen as unalterable. We see a woman born with half a brain that rewired itself to work as a whole, blind people who learn to see, learning disorders cured, IQs raised, aging brains rejuvenated, stroke patients learning to speak, children with cerebral palsy learning to move with more grace, depression and anxiety disorders successfully treated, and lifelong character traits changed. Using these marvelous stories to probe mysteries of the body, emotion, love, sex, culture, and education, Dr. Doidge has written an immensely moving, inspiring book that will permanently alter the way we look at our brains, human nature, and human potential.

Pharmaceutical Dosage Forms - Tablets

By Larry L. Augsburger,Stephen W. Hoag
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : CRC Press
  • Book Code : 1420063863
  • Total of Pages : 1552
  • Category : Medical
  • Members : 298
  • Pdf File: pharmaceutical-dosage-forms-tablets.pdf

Book Short Summary:

The ultimate goal of drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients. Pharmaceutical Dosage Forms: Tablets, Third Edition is a comprehensive resource of the design, formulation, manufacture, and evaluation of the tablet dosage form, an

FDA Quality Standards for Generic Drug Products

By Susan M. Rosencrance,Lawrence Yu
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Academic Press
  • Book Code : 0128112158
  • Total of Pages : 528
  • Category : Medical
  • Members : 164
  • Pdf File: fda-quality-standards-for-generic-drug-products.pdf

Book Short Summary:

FDA Quality Standards for Generic Drug Products features the history and evolution of the FDA’s generic drug program, along with an overview of the quality assessment process performed by the FDA and an in-depth look at quality standards for a variety of dosage forms. Chapters cover important topics such as quality by design, the ANDA structure, CMC, process analytical technology and other emerging technologies, design of experiments and statistics and the similarities and differences between the FDA and international regulatory agencies. Edited and written by experienced leaders in the field, this book contains case studies throughout and provides insider perspectives on what the future may hold for generic drugs. An essential resource for pharmaceutical, regulatory and academic scientists, this book can be used to establish the necessary procedures and specifications in order to seek approval to develop quality products more quickly and easily. Highlights recent developments regarding quality by design and quality standards associated with particular dosage forms, including complex generic drug products Offers an overview of the FDA’s current assessment process for ANDAs, from filing to approval, and discuses important considerations regarding post-approval changes and lifecycle management Written by FDA scientists who actively review ANDAs and develop regulatory policies associated with generic drugs

Pharmaceutical and Biomedical Materials and Technology II

By Jirapornchai Suksaeree
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Trans Tech Publications Ltd
  • Book Code : 3035737193
  • Total of Pages : 323
  • Category : Medical
  • Members : 342
  • Pdf File: pharmaceutical-and-biomedical-materials-and-technology-ii.pdf

Book Short Summary:

Selected peer reviewed full text papers from the 3rd International Conference and Exhibition on Pharmaceutical Sciences and Technology (PST 2020) Selected, peer-reviewed papers from the 3rd International conference and exhibition on Pharmaceutical Sciences and Technology (PST 2020), May 19-20, 2020, Bangkok , Thailand

Discovering and Developing Molecules with Optimal Drug-Like Properties

By Allen C Templeton,Stephen R. Byrn,Roy J Haskell,Thomas E. Prisinzano
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Springer
  • Book Code : 1493913999
  • Total of Pages : 511
  • Category : Medical
  • Members : 943
  • Pdf File: discovering-and-developing-molecules-with-optimal-drug-like-properties.pdf

Book Short Summary:

This authoritative volume provides a contemporary view on the latest research in molecules with optimal drug-like properties. It is a valuable source to access current best practices as well as new research techniques and strategies. Written by leading scientists in their fields, the text consists of fourteen chapters with an underlying theme of early collaborative opportunities between pharmaceutical and discovery sciences. The book explores the practical realities of performing physical pharmaceutical and biopharmaceutical research in the context of drug discovery with short timelines and low compound availability. Chapters cover strategies and tactics to enable discovery as well as predictive approaches to establish, understand and communicate risks in early development. It also examines the detection, characterization, and assessment of risks on the solid state properties of advanced discovery and early development candidates, highlighting the link between solid state properties and critical development parameters such as solubility and stability. Final chapters center on techniques to improve molecular solubilization and prevent precipitation, with particularly emphasis on linking physiochemical properties of molecules to formulation selection in preclinical and clinical settings.

Analytical Techniques in the Pharmaceutical Sciences

By Anette Müllertz,Yvonne Perrie,Thomas Rades
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Springer
  • Book Code : 1493940295
  • Total of Pages : 838
  • Category : Medical
  • Members : 807
  • Pdf File: analytical-techniques-in-the-pharmaceutical-sciences.pdf

Book Short Summary:

The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research.

Melt Extrusion

By Michael A. Repka,Nigel Langley,James DiNunzio
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : Springer Science & Business Media
  • Book Code : 1461484324
  • Total of Pages : 474
  • Category : Medical
  • Members : 276
  • Pdf File: melt-extrusion.pdf

Book Short Summary:

This volume provides readers with the basic principles and fundamentals of extrusion technology and a detailed description of the practical applications of a variety of extrusion processes, including various pharma grade extruders. In addition, the downstream production of films, pellets and tablets, for example, for oral and other delivery routes, are presented and discussed utilizing melt extrusion. This book is the first of its kind that discusses extensively the well-developed science of extrusion technology as applied to pharmaceutical drug product development and manufacturing. By covering a wide range of relevant topics, the text brings together all technical information necessary to develop and market pharmaceutical dosage forms that meet current quality and regulatory requirements. As extrusion technology continues to be refined further, usage of extruder systems and the array of applications will continue to expand, but the core technologies will remain the same.

Pharmaceutical Operations Management

By Pankaj Mohan,Jarka Glassey,Gary A. Montague
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : McGraw Hill Professional
  • Book Code : 0071712089
  • Total of Pages : 386
  • Category : Technology & Engineering
  • Members : 689
  • Pdf File: pharmaceutical-operations-management.pdf

Book Short Summary:

This book brings together a winning team of international operations experts to set the framework for building a world-class manufacturing organization. Pharmaceutical Operations Management focuses on key concepts such as: Policy Execution, Risk Management, Supply chain modeling, Advance process control and Six Sigma for the pharmaceutical industry: critical techniques which will offset cost, increase efficiency and turn any manufacture into financial winner.

Hydrophilic Interaction Chromatography

By Bernard A. Olsen,Brian W. Pack
  • File : Pdf, ePub, Mobi, Kindle
  • Publisher : John Wiley & Sons
  • Book Code : 1118495233
  • Total of Pages : 336
  • Category : Science
  • Members : 749
  • Pdf File: hydrophilic-interaction-chromatography.pdf

Book Short Summary:

Discover how to use HILIC to analyze and better understand polar compounds An increasingly popular analytical method, hydrophilic interaction chromatography (HILIC) has the ability to retain and separate polar compounds that are often difficult to analyze by reversed-phase high-performance liquid chromatography (HPLC) or other analytical methods. Offering a comprehensive review, this book enables readers to develop a fundamental understanding of how HILIC works and then apply that knowledge to develop and implement a variety of practical applications. Hydrophilic Interaction Chromatography begins with discussions of HILIC retention mechanisms, stationary phases, and general method development. This sets the foundation for the book's extensive coverage of applications. The authors address unique separation challenges for bioanalytical, environmental, pharmaceutical, and biochemical applications. Moreover, there is a thorough discussion of HILIC in two-dimensional chromatography. With contributions from leading analytical scientists who have extensive experience in HILIC as well as HPLC, Hydrophilic Interaction Chromatography serves as a practical guide for researchers, featuring: Detailed examples of HILIC methods and development approaches Thorough explanations of retention mechanisms and the impact of stationary phase and mobile phase properties on separations Step-by-step guidance for developing efficient, sensitive, and robust HILIC methods References to the primary literature at the end of each chapter Hydrophilic Interaction Chromatography is written for scientists who use or develop analytical methods for the separation of polar compounds. In particular, these researchers will discover how HILIC can be used to analyze and better understand the composition of pharmaceutical, bioanalytical, biochemical, chemical, food, and environmental samples.