With a high diversity of vegetation in Iran, over 8000 plant species are in existence. More than 2300 species of these plants have medicinal, edible and industrial properties, and more than 1700 species of them are endemic. Natural Products and Botanical Medicines of Iran provides an overview on important endemic plants and their usages. All results have been tabulated and key detailed information of each species is presented with background data. Features: Provides an understanding of indigenous plant-derived natural medicines of the most important medicinal plants in the region Includes discussions and critical views on the potentials and challenges for further development of the selected plants in a modern setting Details the important plants and sets out the chapters based on either taxonomy or medical use

Melville's Monumental Imagination explores the connection between the contested 19th century American monument tradition and one of the nation's most revered authors, Herman Melville (1819-1891). The book was written to fill a void in recent Melville scholarship. To date, there has not been a monograph that focuses exclusively on Melville's incorporation of monuments in his fictional world. The book charts the territory of Melville's novels in order to provide a trajectory of the monumental image in one particular literary form. This feature allows the reader to gradually see the monumental image as an important marker that sheds light into Melville's eventual abandonment of long fiction. Melville's Monumental Imagination combines literary analysis and cultural criticism for a long neglected aspect of our nation's iconic development in statuary.

Presenting breakthrough research pertinent to scientists in a wide range of disciplines-from medicine and biotechnology to cosmetics and pharmacy-this Second Edition provides practical approaches to complex formulation problems encountered in the development of particulate delivery systems at the micro- and nano-size level. Completely revised and expanded to represent the most up-to-date studies in the field, this guide covers advances in pulsatile delivery systems, injectable microparticulate systems, and site-specific delivery systems, as well as potential therapeutic applications of nanotechnology.

The demand for medicinal plants is increasing, and this leads to unscrupulous collection from the wild and adulteration of supplies. Providing high-quality planting material for sustainable use and thereby saving the genetic diversity of plants in the wild is important. In this regard, the methods of propagation of some important medicinal plants are provided along with the traditional methods of propagation. Indian Medicinal Plants: Uses and Propagation Aspects offers a unique compendium of more than 270 medicinal plant species from India with detailed taxonomic classifications based on the Bentham and Hooker system of classification. Salient Features: Provides traditional methods of propagation and discusses the propagation of medicinal plants Presents plant properties, plant parts and chemical constituents Describes the medicinal uses of more than 270 medicinal plant species from India This book is of special interest to practitioners of alternative medicine, students of Ayurveda, researchers and industrialists associated with medical botany, pharmacologists, sociologists and medical herbalists.

1 R. Levy: Types of Filtration.- 2 T. Meltzer: Modus of Filtration.- 3 O.W. Reif: Microfiltration Membranes: Characteristics and Manufacturing.- 4 M. Jornitz: Filter Constructions and Design.- 5 R. Madsen: Filter Validation.- 6 M. Jornitz: Integrity Testing.-

Edited by two of the most distinguished pioneers in genetic manipulation and bioprocess technology, this bestselling reference presents a comprehensive overview of current cell culture technology used in the pharmaceutical industry. Contributions from several leading researchers showcase the importance of gene discovery and genomic technology development in the production of biotechnology products, tissue engineering, and cell-based therapies. Offering detailed guidance, they cover the steps leading up to the creation of viable therapies including host cell selection, cloning and gene amplification, bioreactor design and operation, protein purification, optimization, scale-up, and facility design.

This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.

An expertly written source on the devices, systems, and technologies used in the dissolution testing of oral pharmaceutical dosage forms, this reference provides reader-friendly chapters on currently utilized equipment, equipment qualification, consideration of the gastrointestinal physiology in test design, the analysis and interpretation of data and procedure automation -laying the foundation for the creation of appropriate and useful dissolution tests according to the anticipated location and duration of drug release from the dosage form within the gastrointestinal tract.

The Silk Road, a complex network of trade routes linking China with the rest of the Eurasian continent by land and sea, fostered transformation of the ethnic, cultural, and religious identities of diverse peoples. In Natural Products of Silk Road Plants there is a treasury of plants, many indigenous to countries along the trading routes of the Silk Road, that yielded medicines, cereals, spices, beverages, dyes, and euphoric and exotic compounds previously unknown to the rest of the world. This entry in the Natural Products Chemistry of Global Plants series has been prepared for university students of chemistry and ethnobotany and for those wishing to broaden their knowledge. It opens a window on a vast region of Asia not well described for its flora and provides new and fresh insights on: Significant plants, some endangered Traditional and modern applications of extracts The biochemical and pharmacological properties of extracts Contains over 150 full colour figures The significance of the Silk Road is being revived today through immense investment by China and other eastern countries in major schemes of transport infrastructure.

The Silk Road, a complex network of trade routes linking China with the rest of the Eurasian continent by land and sea, fostered transformation of the ethnic, cultural, and religious identities of diverse peoples. In Natural Products of Silk Road Plants there is a treasury of plants, many indigenous to countries along the trading routes of the Silk Road, that yielded medicines, cereals, spices, beverages, dyes, and euphoric and exotic compounds previously unknown to the rest of the world. This entry in the Natural Products Chemistry of Global Plants series has been prepared for university students of chemistry and ethnobotany and for those wishing to broaden their knowledge. It opens a window on a vast region of Asia not well described for its flora and provides new and fresh insights on: Significant plants, some endangered Traditional and modern applications of extracts The biochemical and pharmacological properties of extracts Contains over 150 full colour figures The significance of the Silk Road is being revived today through immense investment by China and other eastern countries in major schemes of transport infrastructure.

Handbook of Essential Oils: Science, Technology, and Applications presents the development, use and marketing of essential oils. Exciting new topics include insecticidal applications, but there is a continued focus on the chemistry, pharmacology and biological activities of essential oils. The third edition unveils new chapters including the insect repellent and insecticidal activities of essential oils, the synergistic activity with antibiotics against resistant microorganisms, essential oil applications in agriculture, plant-insect interactions, and pheromones and contaminants in essential oils. Features Presents a wide range of topics including sources, production, analysis, storage, transport, chemistry, aromatherapy, pharmacology, toxicology, metabolism, technology, biotransformation, application, utilization, and trade Includes discussions of biological activity testing, results of antimicrobial and antioxidant tests, and penetration enhancing activities useful in drug delivery Covers up-to-date regulations and legislative procedures, together with the use of essential oils in perfumes, cosmetics, feed, food, beverages, and pharmaceutical industries Unveils new chapters including the insect repellent and insecticidal activities of essential oils, the synergistic activity with antibiotics against resistant microorganisms, essential oil applications in agriculture, plant-insect interactions, and pheromones and contaminants in essential oils The American Botanical Council (ABC) named the second edition as the recipient of the 2016 ABC James A. Duke Excellence in Botanical Literature Award and recognized that essential oils are one of the fastest growing segments of the herbal product market

When a problem arises with a product regulated by FDA, the Agency can take a number of actions to protect the public health. Initially, the agency works with the manufacturer to correct the problem voluntarily. If that fails, administrative enforcement and legal remedies include asking the manufacturer to recall a product and having federal marshals seize products if a voluntary recall is not done. Drugs can be seized and medical devices can be detained and imports can be stopped at the port of entry until problems are corrected. If warranted, FDA can ask the courts to issue injunctions or prosecute those that deliberately violate the law. When warranted, criminal penalties-including prison sentences-are sought. Ensuring that your company is in compliance at all times in all departments is a never-ending task. Failure to get it right, even once, can mean excessive fines, penalties, or possible debarment. The FDA Administrative Enforcement Manual explores the control of drug research in pharmaceutical, vaccine, biologic, biotechnology, medical device, and cosmeceutical industries. Introducing basic industry techniques, the author explores every day industry problems and presents suggested methods for applying the theory to resolve them. The book covers the ten critical Administrative Enforcement areas, including recalls, application integrity, injunctions, seizures, and more. It supplements these topics with regulations, lawsuit case studies, enforcement information, and reference materials. Offering insight into the impact of FDA enforcement on the national and international pharmaceutical industry, practitioners and industry suppliers, the book provides an understanding of drug development and manufacturing regulations in the United States and shows you what it takes to keep your company in compliance. The only complete, single source available, the FDA Administrative Enforcement Manual draws on the author's experience in the trenches of the pharmaceutical industry with administrative enforcement activities.

Filling a gap in the literature for a hands-on guide focusing on everyday laboratory challenges, this English edition has been expanded and revised using the feedback received on the successful German precursor. Throughout the book, Professor Mascher draws on his 30 years of experience and provides abundant practical advice, troubleshooting and other hints highlighted in boxes, as well as a broad selection of walkthrough case studies. Based on a course taught by the author, the first part of the book intuitively explains all steps of routine bioanalysis and explains how to set up a robust, inexpensive and effi cient method for a given substance. In the second part he includes 20 worked example cases that highlight common challenges and how to overcome them. With its appendix containing tried-and-tested analytical methods for 100 clinically relevant substances from the author's own laboratory, complete with spectral and MS data as well as literature references and basic pharmacokinetic information, this is a life-long companion for everyone working in clinical, pharmaceutical and biochemical analysis. Comments to the German book: "The book comes to life through its examples, showing not only what did work in the author's laboratory, but also what didn't." ChemieReport "Indispensable for novices, while even old hands will be able to expand their knowledge. A collection of analytical data for ca. 100 substances completes the book's offering, leaving almost nothing to be desired." pharmind

Electrochemical Detection in HPLC: Analysis of Drugs and Poisons is the first monograph devoted to the application of this mode of analysis to the assay of exogenous compounds such as drugs in biological fluids and associated areas. The introductory chapters provide information on basic electrochemistry and HPLC-ED, and on trouble-shooting. The specialized area of thiol analysis is also discussed in detail. Salient practical details of published applications of the technique in analytical toxicology and related areas are provided in a standard format. Alternative techniques are suggested throughout. The emphasis is on the analysis of exogenous compounds, although catecholamines and other endogenous species are discussed in so far as they may be used as drugs. The practical nature of this book will make it useful to professionals working in the field. It will also be of benefit to analysts wishing to use HPLC-ED in the analysis of biological samples for analytes not specifically covered in the volume.

The Progress in Medicinal Chemistry series spans a wide range of topics of interest to the drug discovery community. This particular volume touches upon the following:
* The Herg ion channel
* Fluorescence-based high throughput assay
* Aprepitant and neurokinin receptors
* Muscarinic receptor targets
* Gene activation pathways
* Malaria and antimalarial drugs
* HIV virus mutation and new therapeutics
Progress in Medicinal Chemistry is available online on ScienceDirect - full-text online of volumes 41 onwards.

Elsevier book series on ScienceDirect gives multiple users throughout an institution simultaneous online access to an important compliment to primary research. Digital delivery ensures users reliable, 24-hour access to the latest peer-reviewed content. The Elsevier book series are compiled and written by the most highly regarded authors in their fields and are selected from across the globe using Elsevier's extensive researcher network.

For more information about the Elsevier Book Series on ScienceDirect Program, please visit:
http: //www.info.sciencedirect.com/bookseries/
*Presents the latest research in the field of drug discovery
*Publishes on an annual basis to bring you the most innovative updates in medicinal chemistry
*Available as an online resource via ScienceDirect

In the fast-developing field of nanomedicine, a broad variety of materials have been used for the development of advanced delivery systems for drugs, genes, and diagnostic agents. With the recent breakthroughs in the field, we are witnessing a new age of disease management, which is governed by precise regulation of dosage and delivery. This book presents the advances in the use of metal-based and other nanomaterials for medical imaging, diagnosis, theranostics, and drug delivery. It discusses silver, hybrid gold, and surface-modified magnetic nanoparticles, fluorescent quantum dots, lipid bubbles, and nanobubbles. It provides all available information about these materials and describes in detail their advantages and disadvantages and the areas where they could be utilized successfully. The text also covers topics such as improving bioactivity of poorly soluble actives, cellular and molecular toxicology of nanoparticles, and biofate of nanoemulsions.

With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced. Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices. This book also compares the principle requirements of GMP, and explores the reasoning behind these requirements and ways to comply with them. Relevant topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.

This book examines and evaluates the strategies utilized to design and synthesize pharmaceutically active agents. Significant updates over the last 10 years since the publication of the 1st edition include synthesis of enantiomerically pure isomers, novel chemical methodologies, and new pharmaceutical agents targeted at novel biological endpoints. Written by an experienced successful author, this book meets the needs of a growing community of researchers in pharmaceutical R &D, as well as medical professionals, by providing a useful guide for designing and synthesizing pharmaceutical agents. Additionally, it is a useful text for medicinal chemistry students.

Valuation is a hot topic among life sciences professionals. There is no clear understanding on how to use the different valuation approaches and how to determine input parameters. Some do not value at all, arguing that it is not possible to get realistic and objective numbers out of it. Some claim it to be an art. In the following chapters we will provide the user with a concise val- tion manual, providing transparency and practical insight for all dealing with valuation in life sciences: project and portfolio managers, licensing executives, business developers, technology transfer managers, entrep- neurs, investors, and analysts. The purpose of the book is to explain how to apply discounted cash flow and real options valuation to life sciences p- jects, i.e. to license contracts, patents, and firms. We explain the fun- mentals and the pitfalls with case studies so that the reader is capable of performing the valuations on his own and repeat the theory in the exercises and case studies. The book is structured in five parts: In the first part, the introduction, we discuss the role of the players in the life sciences industry and their p- ticular interests. We describe why valuation is important to them, where they need it, and the current problems to it. The second part deals with the input parameters required for valuation in life sciences, i.e. success rates, costs, peak sales, and timelines.

This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments. It identifies new tools for sample analysis and evaluation and the impact of these advancements on the continuous supply and manufacturing of pharmaceutical products. With more than 100 tables and 430 current references, the book contains a detailed analysis of microbial contamination recalls for nonsterile and sterile pharmaceutical products, demonstrating the distribution of microorganisms worldwide and the identification by geographical regions.

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.

This book is the definitive work on the theory and practice of pharmaceutical tablet and pellet coating. It describes both the practical and theoretical aspects of tablet coating, including the equipment and methods used in laboratory development, scale-up and production systems, More...as well as automation and validation. This book also discusses the problems of conforming to world-wide regulations, and the hazards of environmental pollution.

State-of-the-Art Methods for Drug Safety Assessment Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment. The book's three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation. Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area.

Specialists drawn from industry, agency and academia explain the role of the various elements in the marketing communications process, and show how a reassessment of the marketing mix can result in a positive response to challenges imposed by a changing commercial environment.

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.