The book provides data on all the species of the two genera Genera Brachystelma Sims and Ceropegia L. in India for their bioprospection and conservation. The other objectives are to promote the beauty and uniqueness of the species of these two genera and also to provide medicinal and edible uses for bioprospection.

Sustained-Release Injectable Products focuses on the development process for sustained-release versions of drugs and delivery systems and administration routes. From the rationale and basic product development principles to regulatory issues and the approval process, expert contributions address virtually every aspect. They bring together common threads that apply to any sustained-release formulation, such as scale-up, safety, biocompatibility, analytical challenges, and quality assurance.

Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic manufacture. Topics include the processing of biopharmaceuticals, lyophilization, personnel training, radiopharmaceuticals, hydrogen peroxide vapor sterilization, regulatory requirements, validation, and quality systems.

"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."

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.

This book contains most updated information on synthesis of magnetic nanohybrids, their physio-chemical properties, and key biological applications. It highlights the complexity of nanoheterostructures, especially magnetic metal oxides, ferrites and doped magnetic nanomaterials, and discusses their potential applications in the early detection, imaging and treatment of cancer. It also covers the toxicity and risk assessment of multifunctional nanomaterials. Providing an overview of magnetic nanoheterostructures, it appeals to a wide audience, from beginners and graduate-level students to experts in academia and industry.

Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials. The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues addressed are also important for clinical trials in other settings. After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes.

Clinical Trial Optimization Using R explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. It provides the clinical researcher with a powerful evaluation paradigm, as well as supportive R tools, to evaluate and select among simultaneous competing designs or analysis options. It is applicable broadly to statisticians and other quantitative clinical trialists, who have an interest in optimizing clinical trials, clinical trial programs, or associated analytics and decision making. This book presents in depth the Clinical Scenario Evaluation (CSE) framework, and discusses optimization strategies, including the quantitative assessment of tradeoffs. A variety of common development challenges are evaluated as case studies, and used to show how this framework both simplifies and optimizes strategy selection. Specific settings include optimizing adaptive designs, multiplicity and subgroup analysis strategies, and overall development decision-making criteria around Go/No-Go. After this book, the reader will be equipped to extend the CSE framework to their particular development challenges as well.

"This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.

The purpose of this book is to focus on major considerations in the clinical use of botanicals as an integrated therapy in current health care. The book uses an organ system approach to presenting clinical evidence on the use of botanicals for common conditions. The chapters include brief sections on background and pharmacognosy, preparation and dosing, safety, evidence and clinical application. In addition, several chapters highlight pharmacokinetic and pharmacogenomic considerations with botanicals in precision medicine and their use in special populations. Finally, a summary on the editors' perspective of "challenges and opportunities" is provided, which discusses the practice of botanicals as integrative therapies and where they are heading in the future.

Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries.

Basic Fundamentals of Drug Delivery covers the fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to transform a drug candidate or new chemical entity into a final administrable drug delivery system. The book also covers various approaches involved in optimizing the therapeutic performance of a biomolecule while designing its appropriate advanced formulation.

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends. Key Features: Presents insight into the world of pharmaceutical quality systems Analyzes regulatory trends and expectations Includes approaches and practices used in the industry to comply with regulatory requirements Discusses recent worldwide supply chain issues Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry

Principles of Animal Extrapolation addresses the conceptual basis for animal extrapolation and provides an abundance of documentation that illustrates how these principles may be applied in the selection of the more appropriate models and in the interpretation of toxicological studies. The book analyzes and documents each specific biological cause of interspecies differences in susceptibility to toxic agents, including differences in absorption, gut flora, tissue distribution, metabolism, mechanisms and efficiencies of repair, and excretion. The problem of the heterogenicity of the human population is addressed through several chapters that assess the availability and prospects of developing predictive animal models for normal humans, as well as selected potential high-risk groups. Other topics presented in this book include the biological basis of regulatory actions involving attempts to extrapolate from exceptionally high exposure levels to realistic values, especially carcinogens; an assessment of genotoxicity tests, their ability to predict carcinogenicity in whole animals, and the manner in which they should be used by regulatory agencies; birth defects; and predicting the risk of human teratogenesis. Principle of Animal Extrapolation is essential for environmental toxicologists. It also provides valuable information to biomedical scientists (especially those involved in drug development and testing) and regulatory personnel in agencies such as the EPA, the OSHA, the NIOSH, and the FDA.

The aim of this unique volume is to help medical researchers design clinical trials to improve survival, remission duration, or time to recurrence of disease. Written in a user-friendly step-by-step format, this work enables the researcher-with no background in statistics-to determine sample size and write statistical considerations for their protocols. It provides critical language which can help with FDA submissions and/or research grants. It also provides the mathematical justification of the material at a level consistent with one year of undergraduate mathematical statistics. It presents survival analysis methods at a more elementary level than any known text. Filled with tables, figures, plus an extensive appendix, this one-of-a-kind reference is an absolute must for all clinical researchers and biostatisticians.

This book reviews the current state of ocular drug therapy and future therapeutic opportunities for a wide variety of conditions, including Age-related Macular Degeneration, Diabetic Retinopathy and Macular Edema, Glaucoma, and Inherited Retinal Diseases. Retinal diseases are major contributors to moderate or severe vision impairment in adults aged 50 years and older. The respective patient populations for many of these indications is expected to significantly increase as the world population continues to grow older. An improved understanding of the etiological underpinnings of ocular degenerative diseases over the past decade has significantly bolstered ophthalmic drug discovery. In this volume, contributions from leading experts explore the unique challenges faced for ocular drug discovery and delivery providing the reader with detailed information on ocular pharmacokinetics, in vitro, ex vivo and in vivo models for retinal disease pathology and emerging gene therapy treatments. The book is intended for all researchers and clinicians who wish to increase their knowledge on the latest findings in ocular drug therapy.

While systems biology and pharmacodynamics have evolved in parallel, there are significant interrelationships that can enhance drug discovery and enable optimized therapy for each patient. Systems pharmacology is the relatively new discipline that is the interface between these two methods. This book is the first to cover the expertise from systems biology and pharmacodynamics researchers, describing how systems pharmacology may be developed and refined further to show practical applications in drug development. There is a growing awareness that pharmaceutical companies should reduce the high attrition in the pipeline due to insufficient efficacy or toxicity found in proof-of-concept and/or Phase II studies. Systems Pharmacology and Pharmacodynamics discusses the framework for integrating information obtained from understanding physiological/pathological pathways (normal body function system vs. perturbed system due to disease) and pharmacological targets in order to predict clinical efficacy and adverse events through iterations between mathematical modeling and experimentation.

Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries.

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.

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.

With contributions from leading experts, this book is the first to focus solely on addressing the problems and reviewing the strategies currently being used to improve the delivery of antisense nucleic acids. Important delivery issues, such as improving biological stability, improving cell-specific targeting and cellular uptake, manipulating subcellular distribution and producing liposomal delivery systems for antisense agents are comprehensively covered in this volume. This book links review-type articles with contributions that contain exciting never-before-published data on the cellular delivery of oligonucleotides. It stimulates reading for both established researchers and newcomers to the antisense field.

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.

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.

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.

Bioactive lipid metabolism and signaling are now widely accepted as major players in cancer biology. This volume helps to fill the urgent need to explore and investigate the innovations, current shortcomings, and future challenges of cancer therapy through the bioactive lipids by presenting new research on the use of bioactive lipids as effective weapons against cancer. The volume introduces the subject and then goes on to cover the chemistry, formulation, and mechanism of bioactive lipids in cancer. The volume takes a close look at lipoxins, ceramides, resolvins, and sphingosine-1-phosphate and their roles in cancer treatment. It also addresses the formulations based on bioactive lipids for the treatment of cancer. A variety of mechanisms of bioactive lipids as novel therapies are also covered, including using computational techniques to identify bioactive lipid drug targets, targeting therapy via KRAS and PI3K signals, and others. The authors also discuss the role and effects of various substances and their effect on various cancers, including colorectal cancer, prostate cancer, breast cancer, and others. The application of lysophosphatidic acid, lipopolysaccharide, lipid-soluble bioactive substance from avocado, omega-3 polyunsaturated fatty acids-derived lipid metabolites, and more are covered as well. The volume offers academia, technologists, and scientists from different disciplines valuable information to gain knowledge of bioactive lipid metabolism and signaling as an anti-cancer weapon in their fight against cancer.