This book offers a broad summary of the wild plants and their usage, as well as the growing interest in ethnopharmacology research. The book comprises of important issues such as diversity of wild plants with emphasis on medicinal and food plants, threats to wild plants and traditional ethnobotanical knowledge, their uses in skin diseases, snake-bites, in cosmeceuticals, etc. Moreover, the ethnopharmacological relevance of wild plants in Latin America has been discussed. The chapters include a wide range of case studies, giving updated evidence on the importance of their wild plant resources from different countries including Peru, Nepal, Bangladesh, India, Pakistan, Brazil. In addition, some specific species are used to explain their potential properties, as well as the dangers of their use without guidance of trained natural healers. The book discusses traditional usage and properties of wild plants and is entirely different from other related publications and useful for the researchers working in the areas of conservation biology, botany, ethnobiology, ethnopharmacology, policymakers, etc.

Volume 7 of the Jenny Stanford Series on Biocatalysis deals with several different aspects of pharmaceuticals, which include not only various applications of drugs and their metabolism but also natural resources for active pharmaceutical ingredients as well as the removal of pharmaceutical pollution. In detail, novel approaches for developing microbial fermentation processes to produce vitamin B6 using microorganisms are described together with novel routes for vitamin B6 biosynthesis. The other topics discussed are new approaches for producing the successful anticancer drug Taxol from naturally occurring precursors, molecular farming through plant engineering as a cost-effective means to produce therapeutic and prophylactic proteins, and successful screening of potent microorganisms producing L-asparaginase for various chemotherapeutic applications. Furthermore, microbial biotransformations in the production and degradation of fluorinated pharmaceuticals are described. The other chapters inform the reader about the biotransformation of xenobiotics/drugs in living systems, the degradation of pharmaceuticals by white-rot fungi and their ligninolytic enzymes, and the removal of pharmaceutical pollution from municipal sewage using laccase.

This new volume, Herbal Product Development: Formulation and Applications, addresses some of the challenges that hinder the path of successful natural products from laboratory to market. Highly skilled, experienced, and renowned scientists and researchers from around the globe offer up-to-date information that describes characteristics of herbs and herbal products, applications, evaluation techniques, and more. There is also a section dedicated to alternative medicinal strategies for the treatment and cure of diverse diseases. Also considered, of course, is the efficacy and safety of herbal products, which are of major concern. This valuable volume will be an important addition to the library of those involved in herbal product development and testing, including researchers, scientists, academicians, industry professionals, and students in this area.

The concept of frailty offers a convenient way to introduce unobserved heterogeneity and associations into models for survival data. In its simplest form, frailty is an unobserved random proportionality factor that modifies the hazard function of an individual or a group of related individuals. Frailty Models in Survival Analysis presents a comprehensive overview of the fundamental approaches in the area of frailty models. The book extensively explores how univariate frailty models can represent unobserved heterogeneity. It also emphasizes correlated frailty models as extensions of univariate and shared frailty models. The author analyzes similarities and differences between frailty and copula models; discusses problems related to frailty models, such as tests for homogeneity; and describes parametric and semiparametric models using both frequentist and Bayesian approaches. He also shows how to apply the models to real data using the statistical packages of R, SAS, and Stata. The appendix provides the technical mathematical results used throughout. Written in nontechnical terms accessible to nonspecialists, this book explains the basic ideas in frailty modeling and statistical techniques, with a focus on real-world data application and interpretation of the results. By applying several models to the same data, it allows for the comparison of their advantages and limitations under varying model assumptions. The book also employs simulations to analyze the finite sample size performance of the models.

This book provides a broad range of applications and recent advances in the search for biofilm materials in nature. It also explains the future implications for biofilms in the areas of advanced molecular genetics, pharmaceuticals, pharmacology, and toxicology. This book is comprised of 20 chapters from leading experts in the field and it examines immunology and microbiological studies derived from biofilms as well as explores environmental, agricultural, and chemical impacts on biofilms. It is divided into five subdivisions: biofilms and its complications, biofilm infections in human body, detection of biofilm-forming pathogens, antibiofilm chemotherapy, and biofilms production tools in aquaculture. This book may be used as a text or reference for everyone interested in microbial biofilms and their current applications. It is also highly recommended for environmental microbiologists, medical microbiologists, bioremediation experts, and microbiologists working in biocorrosion, biofouling, biodegradation, water microbiology, quorum sensing, and many other related areas. Scientists in academia, research laboratories, and industry will also find it of interest. This book includes chapter homework problems and case studies. Powerpoints are also available for adopting instructors. Discusses and clarifies the resource of isolation and chemical properties from biofilms Discusses the latest pharmaceutical, pharmacological, and medicinal approaches toward the treatment of chronic and uncured diseases, such as Alzheimer's osteoporotic, sexual dysfunction, sleep sickness, allergy treatment, asthma, hair loss, AIDS, hypertension, antiaging, etc. Examines immunology and microbiological studies derived from biofilms Explores environmental, agricultural, and chemical impacts on biofilms. Dr. Bakrudeen Ali Ahmed Abdul is an Associate Professor, the Head of the Department of Biochemistry and Dean of the School of Life Sciences, Centre for Research and Development (CRD), PRIST Deemed University, Vallam, Thanjavur, Tamil Nadu, India. His research areas include the application of plant biochemistry, bioactive compound production, biotechnological methods, development of pharmaceutical products and pharmacological studies.

This new volume, Promising Drug Molecules of Natural Origin, explores potential beneficial drug substances derived from nature. It presents the general principles, characteristics, evaluation techniques, and applications involved in drug molecules from natural sources, such as plants and marine life. With chapters from renowned experts from around the world, the chapters in this volume address the challenges of standardization of herbal medicines, methods of characterization of natural medicines and phyto-constituents, and quality control methods for herbal medicines. Several chapters in the book focus on the evolution of phyto-constituents in cancer therapeutics, while others deal with applications for other diseases, such as diabetes and neuroinflammatory disorders. The volume also specifically reviews heterocyclic drugs from plants. This volume will be a valuable resource for faculty and advanced students in pharmaceutics as well as researchers, scientists, and industry professionals in medicine and drug development.

Site-specific drug delivery and targeting is attracting much research interest from both academia and industry, but because of the many challenges faced in the development of these systems, only a handful of targeted therapies have successfully made it into clinical practice. Bringing together leading field experts, Targeted Delivery of Small and Macromolecular Drugs summarizes current progress with a focus on the novel ideas being explored to overcome these challenges.

Focuses on the Targeted Drug Delivery Technologies that Utilize
both Systemic and Local Routes of Administration
Leading experts discuss some of the most promising strategies for drug targeting. They also cover targeted drug delivery platforms and technologies at various stages of clinical and preclinical development, including:

? Active targeting
? Nucleic acid delivery and targeting
? Intracellular/Organelle-Specific Strategies
? Prodrug Strategies
? Organ or Tissue-Specific drug delivery
? Drug-Polymer Conjugates and Micelles
? Stimuli-Responsive systems

Targeted Delivery of Small and Macromolecular Drugs demonstrates why targeted delivery is one of the most exciting contributions pharmaceutical sciences can make to drug therapy.

Until now, the area of drug metabolism and pharmacokinetics has been lacking in texts written for the Medicinal Chemist. This outstanding book, aimed at postgraduate medicinal chemists and those working in industry, fills this gap in the literature. Written by medicinal chemists and ADMET scientists with a combined experience of around 300 years, this aid to discovering drugs addresses the absorption, distribution, metabolism, excretion and toxicity (ADMET) issues associated with drugs. The book starts by describing drug targets and their structural motifs before moving on to explain ADMET for the medicinal chemist. It is the functional groups which most profoundly influence the drug molecules of which they form a part. They characterise the pharmacology, are essential to the activity, and alter the ADMET characteristics of each drug. Their effects follow a pattern, thus allowing medicinal chemists to predict and overcome potential challenges. For this reason, the Editors have taken the unique approach of dividing the remainder of the book into chapters which each focus on a different functional group. They describe drugs containing the functional group under consideration, explain why the group is there, and outline its physicochemical properties before going on to detail the ADMET issues. Where possible, prodrugs and bioisosteres, which may give alternative ADMET outcomes, are described. The chapters cross refer where similar matters are covered but individual chapters can be used in a stand alone manner. The book ends with a discussion of future targets and chemistry needs.

Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative. However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country. This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.

Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products. The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.

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.

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

Key topics in Pharmaceutical Computer Systems Validation, Second Edition include:

• GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008
• ICH Guidance Q8, Q9, and Q10 expectations
• FDA cGMPs for the 21st Century Initiative and associated guidance
• PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments
• WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
• the indirect developments from FDA/EU/Japan regulators and industry
• the role of QA department, and internal and external suppliers
• the integration of computer systems validation into single overall approach for wider system
• practical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer system
• managing outsource partners and handling legacy systems
• topical issues uncovered by regulatory authorities including US FDA

Genetic toxicology is considered to be an important assessment tool as there is genetic impact of artificial chemicals. Insight on Genotoxicity discusses testing, mechanism, prediction, and bioindicator of genotoxicity taking into consideration recent advances in nano-engineered particles. Corollary of DNA dent is also discussed in detail taking into consideration the impact of ICH guidelines on genotoxicity testing, which is important for drug discovery innovation and development. Perspective review of genotoxicity evaluation in phytopharmaceuticals has been mentioned along with the prevention of genotoxicity in brief viewpoint. Salient Features Presents methods, standard protocols, and guidelines for genotoxicity testing Examines the impact of ICH Guidelines on genetic toxicity testing which is a regulatory requirement for drug discovery and development Defines appropriate strategies about advances in in vivo genotoxicity testing which have been listed along with progress and prospects Discusses advancement in the high-throughput approaches for genotoxicity testing Details computational prediction of genotoxicity with consideration of mutagenicity, chromosomal damage caused and strategies for computational prediction in drug development

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

This key volume of the Target Organ Toxicology Series provides a fresh and modern approach to the subject of skin toxicology from the perspective of how the skin forms a barrier that protects the body from the external environment and how chemicals and drugs interact with the barrier properties of the skin. Any defects or perturbations to this barrier may result in damage to the skin or may alter absorption. With contributions from over 40 international experts in the field of skin biology, the book presents the central role of the skin barrier to health and disease reviewing; The skin's anatomy and physiology, with focus on the stratum corneum as a barrier to foreign substances. Dermal absorption, cutaneous metabolism, and epidermal transporters. Altered barriers, racial skin types, aged skin, photoaged skin, cosmetics and skin sensitization. Modern approaches to drug delivery across the skin barrier, including liposomes, microneedle technology, active and passive transdermal delivery. Examples and case studies of chemical toxicity after topical exposures ranging from arsenic, metal working fluids, bromine, jet fuel, sulfur mustard and including the emerging area of nanomaterial penetration. Toxicology of the Skin is essential reading for drug delivery pharmacologist, formulation scientists, dermatologists, toxicologists, molecular biologists, engineers, surgeons, students and anyone interested in skin irritation and skin absorption.

This "Second Edition" brings you up-to-date with the quality control regulations for APIs that have been added or amended since the first edition. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries.
REVISION OF A BESTSELLER - provides updates on the quality control regulations for APIs that have been added or amended since the first edition to ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries
NEW CHAPTERS - on safety, efficacy, and environmental/regulatory requirements keeps readers up-to-date with the latest in the field
EXPERT ANALYSIS - of the recent movement of API manufacturing from the US and Europe to countries such as India and China keeps pharmaceutical professionals and drug manufacturers aware of current and potential changes in regulations
DETAILED DISCCUSIONS - of both US and international regulatory requirements and the FDA's intensified foreign inspection program enables readers to adequately prepare for and pass inspections

The activity of many biopharmaceutical polymers is dependent on conformation, and the next several years will see increased interest in the conformational analysis of these polymers resulting from the development of biosimilar or "follow-on" biological products. While a wide variety of approaches to analysis exists, finding the most viable ones would be much easier with a consolidated reference that details the benefits and cost of each approach, with an emphasis on real results and real products.

Explores the Growing Role of Conformational Analysis in Comparing Generic Biopharmaceuticals

Approaches to the Conformational Analysis of Biopharmaceuticals gathers the most useful techniques and methods into a single volume, putting the greatest emphasis on those approaches that have proven the most fruitful. Rather than cover specific uses of techniques in detail, this book provides commercial biotechnologists and researchers with the information and references they need to make good choices about the technology they choose to use. With a large number of references that direct readers to primary source material, it includes studies drawn from the gamut of current literature, covering physical methods, such as differential scanning calorimetry, light scanning, and analytical ultracentrifugation. It also addresses chemical methods, such as hydrogen deuterium exchange and trace labeling, along with infrared, ultraviolet, and Raman spectroscopy.

Written by Roger Lundblad, a true pioneer in protein science, this volume supplies the necessary information researchers need to access when deciding on the most cost-effective approach, including:

• Comparability of biopharmaceuticals
• Characterization of follow-on biologics
• Quality attributes of protein biopharmaceuticals
• Confrontational analysis of biopharmaceutical products

With a clear focus on relevant commercial biotechnology, this book belongs on the shelves of those serious researchers who are paving the way for the next generation of biopharmaceutical polymers.

Consumer interest in diet and nutritional supplements is increasing dramatically. Patients and members of the public are seeking advice from health professionals, nutritionists and food scientists. This book is designed to meet the needs of those professionals who are called upon to advise patients and the general public. It provides also a valuable text for those who are researchers or decision makers in the food and pharmaceutical industries. The text presents a thorough account of this topical subject and enables the reader to appreciate the functions of nutrients in health and common disease states, to understand the current debates over the roles of nutrients and supplements in the diet, and to answer those questions frequently asked by patients and consumers.

Natural Product Chemistry for Drug Discovery provides a comprehensive summary of where natural product chemistry is today in drug discovery. The book covers emerging technologies and case studies and is a source of up-to-date information on the topical subject of natural products. The authors, all experts in their respective fields, provide compelling arguments as to why naturel products should be considered important tools in the drug discovery process. The book will appeal across the board from scientists to professionals, postgraduates and industrial chemists. The case studies selected for inclusion highlight recently marketed drugs and development candidates that have been derived from natural products. These 'real-life' examples show how new technologies, such as advances in screening, isolation, dereplication and prefractionation, have significantly enhanced the discovery process.

"Pharmaceutical Process Engineering, Second Edition" is the ideal introductory text for pharmaceutical scientists and technologists.
With step-by-step methods of drug production and knowledge of major unit operations and key concepts of pharmaceutical engineering, this guide will help to improve communication among the varied professionals working in the pharmaceutical industry.
Key features:
REVISION OF A BESTSELLER - Updates include recent advances in the field to keep pharmaceutical scientists and technologists up-to-date
IDEAL INTRODUCTORY TEXT - Covers basic engineering principles, drug production, and development processes, so scientists can easily convert bulk pharmaceutical products into patient-ready dosage forms
NEW INFORMATION - on quality principles that include quality by design; mathematical and statistical approaches to experimental design; computer aided design; and PAT (process analytical technology) keeps professionals at the forefront of their field
COMPREHENSIVE COVERAGE - Step-by-step methods of drug production, knowledge of major unit operations, and key concepts of pharmaceutical engineering will help to improve communication among the varied professionals working in the pharmaceutical industry

Teaches proper procedures for using tools and analytical methods in a regulated lab setting
All regulated laboratories, including pharmaceutical, clinical testing, and food and cosmetics testing laboratories, must properly execute the calibration of instruments and validation of analytical methods. Following correct procedures ensures the generation of reliable data, which leads to the manufacture of safe and effective products.

Analytical Method Validation and Instrument Performance Verification provides a uniquely practical approach to method validation and instrument performance verification. Each chapter starts with general requirements, then moves to the strategies and steps taken to fulfill these conditions, and finishes with a discussion of practical problems and their solutions. Coverage includes: Method validation of potency, related substances, and dissolution testing Validation for pharmaceutical excipients, heavy metals, and bioanalysis Performance verification for common analytical instruments including HPLC, UV-Vis spectrophotometers, and pH meters The LCMS system calibration Proper environmental chamber qualification Entire qualification process for computer equipment, hardware, and software Validation of Excel spreadsheets Regulatory requirements of the FDA, ICH, Europe, and Japan

Full of practical tips on validation techniques and detailed discussions of instrument performance verification, this comprehensive guide represents a one-stop reference for remaining current in today's regulatory environment.

Analytical Method Validation and Instrument Performance Verification provides an invaluable working reference for laboratory managers, calibrationscientists, and research and development scientists.

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.

In this era of finite budgets, healthcare rationing, medication shortages, and the global aging and burgeoning of populations, numerous stakeholders in the healthcare arena must understand the basic principles of pharmacoeconomics and how these may be correctly applied to facilitate drug development, rationing, patient segmentation, disease management, and pricing model development. Pharmacoeconomics: From Theory to Practice, Second Edition focuses on how to more efficiently and rationally leverage these healthcare resources, not by restricting access to necessary services, but by using them more efficiently. This updated volume arms decision makers with the tools they need to make wise choices in an area where the stakes are extremely high-the health of the global population. Key Features: Introduces the major concepts and principles of Pharmacoeconomics Gives updated information about pharmacoeconomic models, value-based pricing, novel modelling methodologies and international utilization of these modalities in government, the pharmaceutical industry, and health care settings Demonstrates the full range of ethical and moral issues, as well as overall public health and commercial concerns that are often involved in decisions entailing pharmacoeconomic issues Presents both theory and methodology discussions, including real-world examples, in each chapter 'The methods and application of pharmacoeconomics are rapidly evolving, so the new edition of this textbook is very timely. It provides an excellent introduction for those new to the field, whether they be students, professionals within the pharmaceutical industry, or health care professionals more generally. A particularly useful feature of the book is that it gives an introduction both to the main methods used in pharmacoeconomics studies and how these studies are used in decisions about the reimbursement or appropriate use of medicines in several countries.' - Michael Drummond, Professor of Health Economics, University of York

This timely Second Edition reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, and the shift from developing small molecules to the growth of biopharmaceuticals. It meets the need for up-to-date and advanced information for drug preformulation and formulation, and addresses the current trends in the continually evolving pharmaceutical industry.

Ideal for practitioners working in the pharmaceutical industry (including R&D scientists, technicians, and managers), as well as undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology, this text addresses:

• candidate drug selection
• drug discovery and development
• preformulation predictions and drug
• selections
• product design to commercial dosage form
• biopharmaceutical support in formulation
• development
• and more

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