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Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process itself that might limit the generalizability of results. As a result, regulatory reviewers are consistently required to draw conclusions about a drug's safety and efficacy from imperfect data. Efforts are underway within the drug development community to enhance the evaluation and communication of the benefits and risks associated with pharmaceutical products, aimed at increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. Effectively communicating regulatory decisions necessarily includes explanation of the impact of uncertainty on decision making. On February 12 and May 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held public workshops to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, and to consider their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions on February 12 were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. The May 12 workshop presentations and discussions explored tools and approaches to communicating about scientific uncertainties to a range of stakeholders in the drug development process. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products summarizes the presentation and discussion of both events. This report explores potential analytical and communication approaches and identifies key considerations on their development, evaluation, and incorporation into pharmaceutical benefit- risk assessment throughout the entire drug development lifecycle.
Complete, referenced information in an easy-to-use format Many of the monographs in the European Pharmacopiea, the industry standard test for certain groups of ingredients and excipients, do not describe the tests in full, but reference general methods based on test-tube chemistry. When a test fails, you need to know what went wrong, how it can be fixed, and how to convince QA\QC that the tested material is okay. This gives you little time to dig out the relevant scientific literature, literature that is often so old it doesn't show up in an electronic search. Making this knowledge easily accessible and directly applicable to work in the lab, Pharmaceutical Chemical Analysis: Methods for Limit Tests and Identifications explains the purpose of these older tests, the chemistry involved, and hazards to avoid. The book covers the identification of ions and functional groups tests and limit tests respectively. It covers subjects relevant to all the pharmacopoeial identification/limit test and then goes on to describe the individual tests in chapters organized and named as they appear in the European Pharmacopoeia. Each chapter begins with a short discussion on the purpose and rationale of the tests, followed by a review of the physical and chemical characters of the target ion or compound. The author describes the chemical background and logic of the individual procedural steps of the test with formulas and reaction and provides tips on the strengths and weaknesses of these techniques in terms of specificity, ruggedness, and potential procedural pitfalls. Strict regulatory requirements and economic pressures make the pharmaceutical industry understandably reluctant to replace a test that is simple, cheap, and performs well with expensive, unvalidated instrumental techniques. This resource bridges the gap by providing an in-depth understanding of the principles behind the European Pharmacopoeia tests and how to use them, saving you valuable production time.
Marine Biomedicine: From Beach to Bedside assesses current efforts in marine biomedicine and evaluates the implications of recent advances on the future of the field. Richly illustrated in full color to enhance reader comprehension, the book covers four sections. The first one addresses the technology that has recently been brought to bear on the study of marine natural products, including omics and bioinformatic techniques. The second focuses on lead discovery and reviews various products and their biomedical potential. Examples of clinically successful marine products and discussions of approaches to the clinic are presented in the third section while the last section discusses prospects for the future of marine biodiscovery. Highlighting new technologies, this valuable resource provides an overview of both what is currently possible in the field as well as a detailed look at what is being done in marine natural products research.
Research in the pharmaceutical industry today is in many respects quite different from what it used to be only fifteen years ago. There have been dramatic changes in approaches for identifying new chemical entities with a desired biological activity. While chemical modification of existing leads was the most important approach in the 1970s and 1980s, high-throughput screening and structure-based design are now major players among a multitude of methods used in drug discov- ery. Quite often, companies favor one of these relatively new approaches over the other, e.g., screening over rational design, or vice versa, but we believe that an intelligent and concerted use of several or all methods currently available to drug discovery will be more successful in the medium term. What has changed most significantly in the past few years is the time available for identifying new chemical entities. Because of the high costs of drug discovery projects, pressure for maximum success in the shortest possible time is higher than ever. In addition, the multidisciplinary character of the field is much more pronounced today than it used to be. As a consequence, researchers and project managers in the pharmaceutical industry should have a solid knowledge of the more important methods available to drug discovery, because it is the rapidly and intelligently combined use of these which will determine the success or failure of preclinical projects.
Presenting guidelines for predicting and improving separation system performance, this book contains numerous case studies illustrating the practice of scale-up principles in process development. It offers solutions to limitations that occur in real-world purification schemes; methods to model, optimize, and characterize nonlinear separation processes; data comparisons from all stages of production; and industrial separation schemes for products such as synthetic molecules, antibody fragments, IgG, growth factors, and plasmid DNA. The book covers external constraints, separation economics, correlations for transport and kinetic phenomena, and the configuration and parameters of column design.
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.
"Specification of Drug Substances and Products: Development and
Validation of Analytical Methods" is a comprehensive and critical
analysis of the requirements and approaches to setting
specifications for new pharmaceutical products, with an emphasis on
phase-appropriate development and validation of analytical methods.
This book is intended as more than a review of new regional
guidelines, existing regulatory guidance, and industry practices.
It provides a hands-on guide to understanding and applying these in
practice. The authors discuss critical issues, novel approaches,
and future directions while also providing insight into how
International Guidelines were developed and the rationale behind
Opens the door to the sustainable production of pharmaceuticals and fine chemicals
Driven by both public demand and government regulations, pharmaceutical and fine chemical manufacturers are increasingly seeking to replace stoichiometric reagents used in synthetic transformations with catalytic routes in order to develop greener, safer, and more cost-effective chemical processes. This book supports the discovery, development, and implementation of new catalytic methodologies on a process scale, opening the door to the sustainable production of pharmaceuticals and fine chemicals.
Pairing contributions from leading academic and industrial researchers, "Sustainable Catalysis" focuses on key areas that are particularly important for the fine chemical and pharmaceutical industries, including chemo-, bio-, and organo-catalytic approaches to C-H, C-N, and C-C bond-forming reactions. Chapters include academic overviews of current innovations and industrial case studies at the process scale, providing new insights into green catalytic methodologies from proof-of-concept to their applications in the synthesis of target organic molecules.
"Sustainable Catalysis" provides the foundation needed to develop sustainable green synthetic procedures, with coverage of such emerging topics as: Catalytic reduction of amides avoiding LiAlH4 or B2H6Synthesis of chiral amines using transaminasesIndustrial applications of boric acid and boronic acid catalyzed direct amidation reactionsC-H activation of heteroaromaticsOrganocatalysis for asymmetric synthesis
Offering a balanced perspective on current limitations, challenges, and solutions, "Sustainable Catalysis" is recommended for synthetic organic chemists seeking to develop new methodologies and for industrial chemists dedicated to large-scale process development.
Focusing on the application of physical pharmacy, drug design, and drug regulations as they relate to produce effective dosage forms for drug delivery, "Integrated Pharmaceutics" provides a comprehensive picture of pharmaceutical product design, describing the science and art behind the concepts of dosage form development. Combining physical pharmacy, product design, and regulatory affairs issues in a single book, the authors address topics governing drug regulations of United States, European, and Japanese agencies and detail new regulatory guidelines, including quality by design, design space analysis, and blend sample uniformity.
"Pharmacology for Chemists, Second Edition" is aimed at industrial and academic organic chemists holding advanced degrees who are entering the field of medicinal chemistry, and who have had little or no education in or exposure to the biological sciences, especially physiology and pharmacology. The first portion of this book concentrates on biological/pharmacological principles and concepts, and the second portion demonstrates how these concepts and principles are applicable to the medicinal chemists efforts, by describing some selected categories of drugs as examples. The book is not intended to be a textbook of pharmacology, but rather is intended to serve as a tool to prepare the reader for further study and more in depth reading.
The aim and scope of this book is to highlight the sources, isolation, characterization and applications of bioactive compounds from the marine environment and to discuss how marine bioactive compounds represent a major market application in food and other industries. It discusses sustainable marine resources of macroalgal origin and gives examples of bioactive compounds isolated from these and other resources, including marine by-product and fisheries waste streams. In addition, it looks at the importance of correct taxonomic characterization.
"An authoritative look at the application of chemical biology in drug discovery and development"
Based on the award-winning "Wiley Encyclopedia of Chemical Biology" published in 2008, this book explores the role of chemical biology in drug discovery and development. The first part of the book reviews key principles and techniques used in the design and evaluation of drug candidates. The second part elucidates biological mechanisms of certain diseases, illuminating approaches to investigate and target these diseases.
Comprising carefully selected reprints from the "Encyclopedia" as well as new contributions from leading scholars in the field, this book provides researchers in academia and industry with important information to aid in the development of novel agents to treat disease. Self-contained articles cover a variety of essential topics, including: The design, development, and optimization of drug candidatesThe pharmacokinetics and properties of drugsDrug transport and deliveryNatural products and natural product models as pharmaceuticalsBiological mechanisms underlying health and diseaseTreatment strategies for a range of diseases, from HIV to schizophrenia
"Chemical Biology" is a top-notch guide and reference for anyone working in the areas of drug discovery and development, including researchers in chemical biology and other fields such as biochemistry, medicine, and pharmaceutical sciences.
Pharmacy Practice discusses the many factors impinging on daily practice and the place of pharmacy in the delivery of health care. The book goes beyond simply considering how pharmacy is practised and draws on a diverse range of disciplines, including sociology, social policy, psychology, anthropology, history and health economics, with each contributor bringing a unique perspective and insight into that practice. In this fully updated edition, the content and presentation have been thoroughly revised and new material added to reflect the many changes that have occurred in the last edition, particularly in pharmacy and health policy and professional regulation and development. The book provides the background and context for issues currently impacting professional practice and which will determine how pharmacy will develop in the future.
This set of six volumes provides a systematic and standardized description of 23,033 chemical components isolated from 6,734 medicinal plants, collected from 5,507 books/articles published in Chinese and international journals. A chemical structure with stereo-chemistry bonds is provided for each chemical component, in addition to conventional information, such as Chinese and English names, physical and chemical properties. It includes a name list of medicinal plants from which the chemical component was isolated. Furthermore, abundant pharmacological data for nearly 8,000 chemical components are presented, including experimental method, experimental animal, cell type, quantitative data, as well as control compound data. The seven indexes allow for complete cross-indexing. Regardless whether one searches for the molecular formula of a compound, the pharmacological activity of a compound, or the English name of a plant, the information in the book can be retrieved in multiple ways.
Prodrug Design: Perspectives, Approaches and Applications in Medicinal Chemistry provides a focused overview of this critical area of drug discovery, as that continuous process strives not only to discover new drug compounds but also to modify the existing ones. This valuable primer supports this mission of drug development and its goal of reducing undesired effects and improving therapeutic effectiveness of drug compounds. Providing a unique compilation of data, insightful case studies, and review of existing literature in the area, the book will promote innovation in medicinal and pharmaceutical chemistry research, exploring the limitations of existing drugs and their improvement. Prodrug Design reviews marketed compounds, the safety of promoieties, and a detailed classification of prodrugs organized by therapeutic area for easy reference.
This book is the second of two volumes that offer a comprehensive, up-to-date account of current knowledge regarding high-density lipoprotein (HDL), the changes that occur in HDL under different conditions, the clinical applications of HDL, and means of enhancing HDL functionality. In this volume, the focus is on the improvement of HDL, enhancement of its functionality, and the use of HDL for therapeutic purposes. In the first section, up-to-date information is provided on such topics as the tumor regression-promoting and antidiabetic activities of reconstituted HDL containing V156K apolipoprotein A-I, the enhancement of HDL effects by high doses of vitamin C, the benefits derived from incorporation of growth hormones 1 and 2 into rHDL, and the biological functions of omega-3 linolenic acid in rHDL. The enhancement of HDL functionality by policosanol and the resultant benefits are thoroughly examined in a separate section. Readers will also find the latest information on clinical applications of HDL. Here, specific topics include the enhancement of adenoviral gene delivery and the delivery of rapamycin. In documenting the latest knowledge in this field, this volume will be of interest to both researchers and clinicians.
This book is the first of two volumes that offer a comprehensive, up-to-date account of current knowledge regarding high-density lipoprotein (HDL), the changes that occur in HDL under different conditions, the clinical applications of HDL, and means of enhancing HDL functionality. HDL comprises a diverse group of lipoproteins and its composition and metabolism are dynamic. In this volume, the focus is on the changes observed in HDL under different health statuses, with particular attention to the functional and structural correlations of HDL and apolipoprotein A-1. The impacts of a wide variety of factors on HDL are examined in depth, covering, for example, diet, exercise, smoking, age, diverse diseases, and different forms of environmental pollution. It has long been known that HDL has anti-atherosclerotic and antidiabetic properties, and more recently its anti-aging activities have been recognized. These benefits of HDL are highly dependent on its lipids, proteins, apolipoproteins, and enzymes, and specifically their composition and ratios. In documenting the latest knowledge in this field, this volume will be of interest to both researchers and clinicians.
This book comprehensively reviews the state-of-the-art strategies developed for protein-protein interaction (PPI) inhibitors, and highlights the success stories in new drug discovery and development. Consisting of two parts with twelve chapters, it demonstrates the design strategies and case studies of small molecule PPI inhibitors. The first part discusses various discovery strategies for small molecule PPI inhibitors, such as high throughput screening, hot spot-based design, computational approaches, and fragment-based design. The second part presents recent advances in small molecule inhibitors, focusing on clinical candidates and new PPI targets. This book has broad appeal and is of significant interest to the pharmaceutical science and medicinal chemistry communities.
This book focuses on biodegradable polymers that are already in clinical use or under clinical development. Synthetic and natural polymers will be included. This excludes polymers that have been investigated and did not reach clinical development.
The purpose of this book is to provide updated status of the polymers that are clinical use and those that are now being developed for clinical use and hopefully will reach the clinic during the next 5 years. The book provides information that of interest to academics and practicing researchers including chemists, biologists and bioengineers and users: physicians, pharmacists.
Designed for pharmacy students
Now updated for its "Second Edition, Thermodynamics of Pharmaceutical Systems" provides pharmacy students with a much-needed introduction to the mathematical intricacies of thermodynamics in relation to practical laboratory applications. Designed to meet the needs of the contemporary curriculum in pharmacy schools, the text makes these connections clear, emphasizing specific applications to pharmaceutical systems including dosage forms and newer drug delivery systems.
Students and practitioners involved in drug discovery, drug delivery, and drug action will benefit from Connors' and Mecozzi's authoritative treatment of the fundamentals of thermodynamics as well as their attention to drug molecules and experimental considerations. They will appreciate, as well, the significant revisions to the Second Edition. Expanding the book's scope and usefulness, the new edition:
Explores in greater depth topics most relevant to the pharmacist such as drug discovery and drug delivery, supramolecular chemistry, molecular recognition, and nanotechnologies
Moves the popular review of mathematics, formerly an appendix, to the front of the book
Adds new textual material and figures in several places, most notably in the chapter treating noncovalent chemical interactions
Two new appendices provide ancillary material that expands on certain matters bordering the subject of classical thermodynamics
Thermodynamics need not be a mystery nor confined to the realm of mathematical theory. Thermodynamics of Pharmaceutical Systems, Second Edition demystifies for students the profound thermodynamic applications in the laboratory while also serving as a handy resource for practicing researchers.
This book guides medicinal chemists in how to implement early ADMET testing in their workflow in order to improve both the speed and efficiency of their efforts. Although many pharmaceutical companies have dedicated groups directly interfacing with drug discovery, the scientific principles and strategies are practiced in a variety of different ways. This book answers the need to regularize the drug discovery interface; it defines and reviews the field of ADME for medicinal chemists. In addition, the scientific principles and the tools utilized by ADME scientists in a discovery setting, as applied to medicinal chemistry and structure modification to improve drug-like properties of drug candidates, are examined.
This book offers an important reference source about the most common classes of pesticides for researchers engaged in the area of neurotoxicology, metabolism, and epidemiology. The book presents details about thorough characterization of target and non-target enzymes and proteins involved in toxicity and metabolism; and epidemiology of poisonings and fatalities in people from short- and long- term exposures to these pesticides in different occupational settings on an individual country basis as well as on a global basis. The early portion of the book deals with metabolism, mechanisms and biomonitoring of anticholinesterase pesticides, while the later part deals with epidemiological studies, regulatory issues, and therapeutic intervention.
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