This book provides detailed instructions for reading and writing a patent. The book presents useful instructions for undergraduate and graduate students as well as post-doctoral, researchers and professors in the field of Chemistry and related areas. Written from a practical point of view it answers the simple and often asked question: how should I read and write a patent? The book is particularly directed to graduate students, who are initiating their research and often lack experience with patents. The ability to write and comprehend patents is fundamental for the success of their projects.

Helping you become a creative, logical thinker and skillful "simulator," Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies provides broad coverage of the entire drug development process, from drug discovery to preclinical and clinical trial aspects to commercialization. It presents the theories and methods needed to carry out computer simulations efficiently, covers both descriptive and pseudocode algorithms that provide the basis for implementation of the simulation methods, and illustrates real-world problems through case studies. The text first emphasizes the importance of analogy and simulation using examples from a variety of areas, before introducing general sampling methods and the different stages of drug development. It then focuses on simulation approaches based on game theory and the Markov decision process, simulations in classical and adaptive trials, and various challenges in clinical trial management and execution. The author goes on to cover prescription drug marketing strategies and brand planning, molecular design and simulation, computational systems biology and biological pathway simulation with Petri nets, and physiologically based pharmacokinetic modeling and pharmacodynamic models. The final chapter explores Monte Carlo computing techniques for statistical inference. This book offers a systematic treatment of computer simulation in drug development. It not only deals with the principles and methods of Monte Carlo simulation, but also the applications in drug development, such as statistical trial monitoring, prescription drug marketing, and molecular docking.

Incidences of inflammatory airway diseases are on the rise across the world. Existing therapeutic options are ineffective, unsafe, and expensive, and severe cases are nonresponsive to conventional therapy. Therefore, it is imperative that research be undertaken to discover new treatment options. Obstructive Airway Diseases: Role of Lipid Mediators discusses clinically successful and potential lipid targets that can make a difference in treating some of the most intractable disease states. Topics discussed include: Obstructive airway diseases, etiology, pathophysiology, and existing therapeutic options What constitutes a lipid and how it is broken down to generate biologically active mediators The role of enzymes in the process of lipid mediator synthesis The biology of arachidonic acid, platelet-activating factor, and lysophosphatidic acid and the role they play in airway inflammation Products of arachidonic acid metabolism such as leukotrienes, prostaglandins, epieicosatrienoic acid, and oxoeicosatetraenoic acid Proresolution lipid mediators in inflammatory airway disease conditions The role of sphingosine and ceramide in inflammatory airway disease Protein kinases activated by lipid mediators and those that trigger the generation of lipid messengers The combined input of a panel of international authorities on lipid mediators makes this volume a valuable resource for all those involved in researching, teaching, and studying airway inflammation as well as those involved in drug discovery research. Punit Srivastava maintains a blog with additional information about the book and his work.

Stroke remains one of the major causes of death and long-term disability worldwide. Currently, the only approved therapy for the acute treatment of this disease is thrombolysis, a strategy that can only be applied to a small percentage of patients due to its narrow therapeutic window. Unfortunately, during the last years numerous promising drugs that showed neuroprotection in the experimental setting failed to translate into the clinic because of their toxicity or lack of efficacy. Researchers in the field now face the crucial need to develop effective stroke therapies and successfully translate novel strategies into the clinical setting. Rational Basis for Clinical Translation in Stroke Therapy presents the most recent promising preclinical approaches and the most updated clinical evidence for treating stroke patients. By bringing together the experience of accomplished stroke researchers and clinicians, the book is a useful tool for improving the treatment and management of stroke patients. The book describes current approaches for the management of stroke patients including thrombolysis and mechanical recanalization procedures as well as other clinically relevant topics such as diagnosis, imaging, risk factors, and prevention. Also described are emerging interventions based on the use of stem cells, botulinum toxin, and antidepressants which complement emergency stroke treatment and conventional rehabilitation procedures. Clinical approaches are integrated with the most promising therapeutic opportunities based on targeting the immune system, hypothermia, and postconditioning. The book also covers issues related to the improvement of R&D strategies in stroke therapeutics, aimed at the implementation of preclinical approaches with stroke model guidelines and at the optimization of clinical trial design. This volume is a reference for all those interested in the rational development of novel stroke therapeutics.

During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production. With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors' more than two decades of experience in the pharmaceutical and biotech industries, the text offers hands-on training based on current approaches and techniques. The book does not merely provide guidelines or thought processes, rather it gives ready-to-use formulas to develop Master Plan, SOPs, and validation protocols. It includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. It also provides the training guidelines on downloadable resources to enable users to amend or adopt them as necessary. Grounded in practicality, the book's applicability and accessibility set it apart. It can be used as a guide for implementing a cleaning validation program on site without the help of external consultants, making it a resource that will not be found collecting dust on a shelf, but rather, referred to again and again.

This practical book provides toxicologists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology, Third Edition is an up-to-date guide to required safety assessment for the entire range of man-made marketed products. Individual chapters written by experts with extensive experience in the field address requirements not only for human pharmaceuticals and medical devices (for which there are available guidances), but for the full range of man-made products. New in this edition are three chapters addressing Safety Data Sheet Preparation, Regulatory Requirements for GMOs, and Regulatory Requirements for Tobacco and Marijuana. The major administrative divisions for regulatory agencies and their main responsibilities are also detailed, as are the basic filing documents the agencies require. Coverage includes food additives, dietary supplements, cosmetics, over-the-counter drugs, personal care and consumer products, agriculture and GMO products, industrial chemicals, air and drinking water regulations and the special cases of California's Proposition 65, requirements for safety data sheets, and oversight regulations. Both US and international requirements are clearly presented and referenced. In one volume, those who have regulatory responsibility in companies, lawyers, educators, and those selling these materials in the marketplace can learn about regulatory requirements and how to meet them.

Reviews phyto-actives and their targeted action in the management of various cancers Looks at the use of phytochemical-based nano-cosmeceuticals for beautification Explores emerging concepts of vitamins and nanocarriers as nutraceuticals Discusses the advantages of bioactive-loaded nanomedicines over conventional phytotherapies

This volume details state-of-the- art methods on computer-aided antibody design. Chapters guide readers through information on antibody sequences and structures, modeling antibody structures and dynamics, prediction and optimization of biological and biophysical properties of antibodies, prediction of antibody-antigen interactions, and computer-aided antibody affinity maturation and beyond. Written in the format of the highly successful Methods in Molecular Biology series, each chapter includes an introduction to the topic, lists necessary materials and reagents, includes tips on troubleshooting and known pitfalls, and step-by-step, readily reproducible protocols. Authoritative and cutting-edge, Computer-Aided Antibody Design aims to be a useful and practical guide to new researchers and experts looking to expand their knowledge. Chapter 2 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.

Nanomaterials, with their unique size-dependent physical and chemical properties, have shown promising advantages as drug and gene delivery vehicles, ultra-sensitive intracellular detectors and novel therapeutic drugs. Nanopharmaceutics is one of the disciplines that will benefit the most from this technology.Nanotechnology will have a revolutionary impact on cancer diagnosis and therapy due to the exceptional characteristics of nanopharmaceutics.This book provides an overview of some tools, methods, and materials of nanotechnology that offer potential applications in pharmaceutics, followed by a series of examples showing applications that are already in development. It may very well inspire researchers to develop a new generation of pharmaceutics with inventive non-traditional approach and employ nanoscale science for the benefit of the patient.

Bioassay Methods in Natural Product Research and Drug Development contains the proceedings from the Phytochemical Society of Europe's very successful symposium on this topic, held August 24-27, 1997, in Uppsala, Sweden.

In this volume, leading academic and industrial scientists discuss novel methods for assaying natural products to find new structure-activity relationships. Of key importance in this process is the availability and reliability of specific bioassay methods, but chapters also discuss chemical and biological diversity and how to dereplicate natural product extracts to increase efficiency in lead discovery.

Anti-tumor, HIV-inhibitory, antiprotozoal, anti-infective and immunomodulatory natural products are discussed. Various industrial projects are presented for the first time.

This volume bridges the gap between academic and industrial research and scientists, and should be required reading in drug companies and faculties of pharmacy, as well as serving scientists in pharmacognosy, pharmacology, phytochemistry, natural products and drug discovery.

Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC). Filled with case studies, examples, and easy-to-follow explanations of how to perform statistics in modern software, it is the first book on CMC statistics written primarily for practitioners. While statisticians will also benefit from this book, it is written particularly for industry professionals who don't have access to a CMC statistician or who want to be more independent in the design and analysis of their experiments. Provides an introduction to the statistical concepts important in the biotechnology industry Focuses on concepts with theoretical details kept to a minimum Includes lots of real examples and case studies to illustrate the methods Uses JMP software for implementation of the methods Offers a text suitable for scientists in the industry with some quantitative training Written and edited by seasoned veterans of the biotechnology industry, this book will prove useful to a wide variety of biotechnology professionals. The book brings together individual chapters that showcase the use of statistics in the most salient areas of CMC.

Hot-melt extrusion (HME) - melting a substance and forcing it through an orifice under controlled conditions to form a new material - is an emerging processing technology in the pharmaceutical industry for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. Hot-Melt Extrusion: Pharmaceutical Applications covers the main instrumentation, operation principles and theoretical background of HME. It then focuses on HME drug delivery systems, dosage forms and clinical studies (including pharmacokinetics and bioavailability) of HME products. Finally, the book includes some recent and novel HME applications, scale -up considerations and regulatory issues. Topics covered include: * principles and die design of single screw extrusion * twin screw extrusion techniques and practices in the laboratory and on production scale * HME developments for the pharmaceutical industry * solubility parameters for prediction of drug/polymer miscibility in HME formulations * the influence of plasticizers in HME * applications of polymethacrylate polymers in HME * HME of ethylcellulose, hypromellose, and polyethylene oxide * bioadhesion properties of polymeric films produced by HME * taste masking using HME * clinical studies, bioavailability and pharmacokinetics of HME products * injection moulding and HME processing for pharmaceutical materials * laminar dispersive & distributive mixing with dissolution and applications to HME * technological considerations related to scale-up of HME processes * devices and implant systems by HME * an FDA perspective on HME product and process understanding * improved process understanding and control of an HME process with near-infrared spectroscopy Hot-Melt Extrusion: Pharmaceutical Applications is an essential multidisciplinary guide to the emerging pharmaceutical uses of this processing technology for researchers in academia and industry working in drug formulation and delivery, pharmaceutical engineering and processing, and polymers and materials science. This is the first book from our brand new series Advances in Pharmaceutical Technology. Find out more about the series here.

The legislative requirement for cannabis to undergo laboratory testing has followed legalization of medical and recreational use in every U.S. state to date. Cannabis safety testing is a new investment opportunity within the emerging cannabis market that is separate from cultivation, processing, and distribution, allowing individuals and organizations who may have been reluctant to enter previously a new entry route to the cannabis space. However, many of the costs, timelines, operational requirements, and compliance issues are overlooked by people who have not been exposed to regulated laboratory testing. Cannabis Laboratory Fundamentals provides an in-depth review of the key issues that impact cannabis testing laboratories and provides recommendations and solutions to avoid common - but expensive - mistakes. The text goes beyond methodology to include sections on economics, regulation, and operational challenges, making it useful for both new and experienced cannabis laboratory operators, as well as all those who want to understand the opportunities and risks of this industry.

While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages. Highlights from Liquid Products, Volume Three include: practical details involved in complying with the current good manufacturing practice requirements in liquid manufacturing access to what an FDA auditor would be looking for during a liquid manufacturing audit issues that may arise during a US FDA inspection the protocols used for stability testing for new drugs and new dosage forms, drawn from the most current ICH guidelines

Explore Important Tools for High-Quality Work in Pharmaceutical Safety Statistical Methods for Drug Safety presents a wide variety of statistical approaches for analyzing pharmacoepidemiologic data. It covers both commonly used techniques, such as proportional reporting ratios for the analysis of spontaneous adverse event reports, and newer approaches, such as the use of marginal structural models for controlling dynamic selection bias in the analysis of large-scale longitudinal observational data. Choose the Right Statistical Approach for Analyzing Your Drug Safety Data The book describes linear and non-linear mixed-effects models, discrete-time survival models, and new approaches to the meta-analysis of rare binary adverse events. It explores research involving the re-analysis of complete longitudinal patient records from randomized clinical trials. The book discusses causal inference models, including propensity score matching, marginal structural models, and differential effects, as well as mixed-effects Poisson regression models for analyzing ecological data, such as county-level adverse event rates. The authors also cover numerous other methods useful for the analysis of within-subject and between-subject variation in adverse events abstracted from large-scale medical claims databases, electronic health records, and additional observational data streams. Advance Statistical Practice in Pharmacoepidemiology Authored by two professors at the forefront of developing new statistical methodologies to address pharmacoepidemiologic problems, this book provides a cohesive compendium of statistical methods that pharmacoepidemiologists can readily use in their work. It also encourages statistical scientists to develop new methods that go beyond the foundation covered in the text.

Useful Statistical Approaches for Addressing Multiplicity Issues Includes practical examples from recent trials Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, Multiple Testing Problems in Pharmaceutical Statistics explores the rapidly growing area of multiple comparison research with an emphasis on pharmaceutical applications. In each chapter, the expert contributors describe important multiplicity problems encountered in pre-clinical and clinical trial settings. The book begins with a broad introduction from a regulatory perspective to different types of multiplicity problems that commonly arise in confirmatory controlled clinical trials, before giving an overview of the concepts, principles, and procedures of multiple testing. It then presents statistical methods for analyzing clinical dose response studies that compare several dose levels with a control as well as statistical methods for analyzing multiple endpoints in clinical trials. After covering gatekeeping procedures for testing hierarchically ordered hypotheses, the book discusses statistical approaches for the design and analysis of adaptive designs and related confirmatory hypothesis testing problems. The final chapter focuses on the design of pharmacogenomic studies based on established statistical principles. It also describes the analysis of data collected in these studies, taking into account the numerous multiplicity issues that occur. This volume explains how to solve critical issues in multiple testing encountered in pre-clinical and clinical trial applications. It presents the necessary statistical methodology, along with examples and software code to show how to use the methods in practice.

The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.

Presents health benefits and medicinal importance of dietary polyphenols having antioxidative effects and their possible preventive role against oxidative stress (OS)-induced chronic human diseases Summarizes latest understanding on the biochemical mechanism(s) involved in the antioxidative action of dietary polyphenols along with their bioavailability, pharmacokinetic, and toxicological considerations Highlights novel approaches of drug discovery from dietary polyphenols through computational screening of bioactive phytochemical components

Describes the thermodynamics and kinetics underlying hydrophobic interaction chromatography of proteins. Outlines use of a kinetic model in the predictive modeling of evaporation processes that eliminates the need to know the composition and identity of the chemical constituents in the sample. Explores building and employing QSRR models in cyclodextrin modified high-performance liquid chromatography (HPLC). Reviews chemometric methods commonly paired with comprehensive 2D separations and key instrumental and preprocessing considerations.

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

This volume is an important advancement in the application ofpharmacokinetic (PK) and pharmacodynamic (PO) principles to . drug development. The series of topics presented deal with the application of these tools to everyday decisions that a pharmaceutical scientist encounters. The ability to integrate these topics using PK and PO methods has optimized drug development pathways in the clinic. New technologies in the areas of in vitro assays that are more predictive of human absorption and metabolism and advancement in bioanalytical assays are leading the way to minimize drug failures in later, more expensive clinical development programs. of Pharmacokinetics and pharmacodynamics have become an important component understanding the drug action on the body and is becoming increasingly important in drug labeling due to it's potential for predicting drug behavior in populations that may be difficult to study in adequate numbers during drug development. The ability to correlate drug exposure to effect and model it during the drug development value chain provides valuable insight into optimizing the next steps to derive maximum information from each study. These principles and modeling techniques have resulted in an expanded and integrated view of PK and PO and have led to the expectations that we may be able to optimally design clinical trials and eventually lead us to identifying the optimal therapy for the patient, while minimizing cost and speeding up drug development. There is wide utility for the book both as a text and as a reference.

Now fully updated for its fourth edition, Pharmacy: What It Is and How It Works continues to provide a comprehensive review of all aspects of pharmacy, from the various roles, pathways and settings of pharmacists to information about how pharmacy works within the broader health care system. Beginning with a brief historical perspective on the field, the book discusses the many facets of the pharmacy profession. It describes the role of pharmacists in different settings and provides information ranging from licensing requirements to working conditions, highlighting the critical role of pharmacists within the health care system. The author examines the drug use process with sections on distribution, prescribing, dispensing, and pricing. He also discusses the role of pharmacy support personnel. A chapter on informatics explores how pharmacy has evolved through information technology and automation. Additional chapters cover poison control, pharmaceutical care, pharmacy organizations, the drug approval process, and career development. Designed for classroom and professional use, the book contains numerous tools to facilitate comprehension, including: Learning objectives to help readers focus on the goals of each chapter Informative tables and figures summarizing data Summary paragraphs tying in salient points Discussion questions and exercises to test assimilation "Challenges" which place the material in broader context Websites and references to encourage further study This valuable text provides a look into the profession that is both broad and deep, supplying a one-stop introduction to a promising career in pharmacy.

Timely coverage of cleaning validation for the phamaceutical industry, a dynamic area in terms of health-based limits. Author encourages pharmaceutical manufacturers, and particularly upper management, to meet the challenges of the science-based and risk-based approaches to cleaning validation. Draws on the author's vast experience in the field of cleaning validation and hazardous materials Discusses EMA vs. ISPE on Cleaning Limits and revised Risk-MaPP for highly hazardous products in shared facilities Diverse list of topics from protocol limits for yeasts and molds to cleaning validation for homeopathic drug products

Numerous herbal plants are used as an important source of life saving drugs for the world's population. Herbal plants are the natural source of several medicines, mainly due to their secondary metabolites, and have long been in use as medicine in the crude extract form. They are also used to isolate the bioactive compounds in modern medicine and herbal medicine systems. They play an important role in the development, synthesis, and formulation of new drugs. Includes chapters on relevant topics contributed by experts of the subjects to make available a comprehensive treatise with in-depth analysis. Audience - those specifically in herbal plant-based drug formulation - presents biotechnological techniques to obtain the desirable products from some specific herbal plants.

The Art of Drug Synthesis illustrates how chemistry, biology, pharmacokinetics, and a host of other disciplines come together to produce successful medicines. The authors have compiled a collection of 21 representative categories of drugs, from which they have selected as examples many of the best-selling drugs on the market today. An introduction to each drug is provided, as well as background to the biology, pharmacology, pharmacokinetics, and drug metabolism, followed by a detailed account of the drug synthesis.* Edited by prominent scientists working in drug discovery for Pfizer* Meets the needs of a growing community of researchers in pharmaceutical R&D* Provides a useful guide for practicing pharmaceutical scientists as well as a text for medicinal chemistry students* An excellent follow-up to the very successful first book by these editors, Contemporary Drug Synthesis, but with all new therapeutic categories and drugs discussed.