Showing posts with label Product Development. Show all posts
Showing posts with label Product Development. Show all posts

Monday, August 19, 2013

Mycelium Running: How Mushrooms Can Help Save the World


Mycelium Running: How Mushrooms Can Help Save the World by Paul Stamets covers mycorestoration (biotransforming stripped land), mycofiltration (creating habitat buffers), mycoremediation (healing chemically harmed environments), and mycoforestry (creating truly sustainable forests) with greater than 300 full-color photographs.

It's a handbook for the mycological rescue of the planet. That’s right: rising moremushrooms may be the very best factor we will do to save the surroundings, and in this groundbreaking text from mushroom knowledgeable Paul Stamets, you’ll find out how. The basic science goes like this: Microscopic cells called “mycelium”--the fruit of which are mushrooms, nitrogen, and other important elements as they break down plant and animal debris in the creation of wealthy new soil.

What writer has discovered is that we can capitalize on mycelium’s digestive power and goal it to decompose toxic wastes and pollutants (mycoremediation), catch and scale back silt from streambeds and pathogens from agricultural watersheds (mycofiltration), control insect populations (mycopesticides), and usually enhance the health of our forests and gardens (mycoforestry and myco-gardening).

In this complete information, you’ll find chapters detailing each of those 4 exciting branch of what Stamets has coined “mycorestoration,” and chapters on the medicinal and nutritional properties of mushrooms, inoculation methods, log and stump tradition, and species selection for varied environmental purposes. Closely referenced and superbly illustrated, this book is destined to be a basic reference for bemushroomed generations to come.

Creator has given you these possibilities by observing space of the pure world most of us have ignored. He has directed his consideration to mushrooms and mycelium and has used his unique intelligence and intuition to make discoveries of great sensible import. I believe you can find it exhausting not to share the keenness and passion he brings to those pages.

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Tuesday, July 30, 2013

Drug Discovery Handbook by Shayne Cox Gad


Drug Discovery Handbook by Shayne Cox Gad gives professionals a tool to facilitate drug discovery by bringing together, for the first time in one resource, a compendium of methods and techniques that need to be considered when developing new drugs.

This comprehensive, practical guide presents an explanation of the latest techniques and methods in drug discovery, including genomics, proteomics, high-throughput screening, and systems biology. Summaries of how these techniques and methods are used to discover new central nervous system agents, antiviral agents, respiratory drugs, oncology drugs, and more.

There are specific approaches to drug discovery, including problems that are encountered, solutions to these problems, and limitations of various methods and techniques. The thorough coverage and practical, scientifically valid problem-solving approach of this book will serve as an invaluable aid in the complex task of developing new drugs.

Author provides in one volume most of the currently used and emerging technologies available and presents a wealth of information on topics that are difficult to find elsewhere. It is very useful handbook and will be of great value to medicinal chemists and organic chemists, pharmacologists, physicians, researchers, and everyone interested in the development of therapeutic drugs.

The quality and breadth of the 'Drug Discovery Handbook' make it indispensable for professionals, and endlessly engaging for those interested in discovering more about new drugs. It is an authoritative, comprehensive, and state-of-the-art reference source. Thorough coverage and practical, scientifically valid problem-solving approach make it an indispensable aid to anyone involved in the complex task of developing new drugs.

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The Clinical Audit in Pharmaceutical Development


The Clinical Audit in Pharmaceutical Development by Michael Hamrell adds quality to the pharmaceutical clinical development process by detailing the need for, and stressing the importance of, an independent audit of clinical data to protect participants and validate study results.

This book examines the use of personal computers, the Internet, and third-party organizations to assist in data validation! Positioning the audit as the only reliable tool to verify that a drug has been shown to be safe and effective in clinical trials, it recommends establishing auditing and quality assurance at the beginning of a clinical study.

This book describes Good Clinical Practices (GCPs) and the role of regulatory agencies in the review, validation, and auditing processes. It outlines the clinical process, from trial design through report writing, compares and contrasts United States and international regulatory statutes, identifies monitoring as the key to guaranteeing high-quality data and focuses on the role of the clinical audit in achieving unity in a multinational study.

Author discusses the worldwide influence of the US Food and Drug Administration audit, analyzes findings from previous FDA clinical audits to reveal trends and future directions, provides guidelines for fraud detection and considers the ramifications of falsified data and more!

Confirming that all clinical information has been properly collected and reported, it is a crucial reference for clinical and research pharmacists and pharmacologists; biostatisticians; clinical research associates, coordinators, and investigators; quality control, quality assurance, and regulatory compliance managers; and upper-level undergraduate and graduate students in these disciplines.

In particular, this is an important book given recent disclosures regarding fraud and misconduct in clinical research; the audit of clinical trial data is important to avoid this problem in future research. The editor has achieved his stated purpose/objectives. Although the editor does not specify an audience for this text, it would be suitable for a wide range of individuals involved in either designing or auditing clinical trial data.

This would include quality assurance personnel in the pharmaceutical industry or in governmental regulatory agencies, individuals from contract research organizations (CRO), members of institutional review boards (IRB) committees, or clinical investigators. The editor of the text is a consultant in this field; chapters are written by eleven contributors whose expertise appears to be related to the field of quality assurance of clinical trial data. Unfortunately, biographies of these individuals are not provided for the reader.

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Monday, July 29, 2013

Biopharmaceutics Applications in Drug Development, Krishna


Biopharmaceutics Applications in Drug Development, by Rajesh Krishna and Lawrence Yu presents an integrated view linking pharmaceutics and the biological consequences to drug development decision making.’ It is written primarily for those who work in the pharmaceutical industry applying biopharmaceutics and pharmacokinetics, or interacting with formulation scientists.

The book will also be useful for those in academic and research environments. It could be valuable for students of biopharmaceutics in undergraduate or graduate programs in pharmaceutical science, and should find a role as an innovative pharmD curriculum elective. In the last two decades, the discipline of biopharmaceutics has undergone considerable advances, particularly with regard to bioavailability and bioequivalence as they relate to product quality and regulatory standards of approval.

Textbooks in the field have not been able to keep up with the growth of current and emerging applications of regulatory aspects of biopharmaceutics. It fills this gap. This book introduces fundamental concepts, methods, and advances in the areas of dissolution, absorption, and permeability and their key applications in dosage form performance.

Case studies are used to discuss the applications of biopharmaceutic strategies in the development of successful drugs, with a specific focus on the applications of biopharmaceutic strategies in the development of successful drugs. The book presents an integrated view in linking pharmaceutic to the biological consequences of drug products and leverages those for decision making in drug development.

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Guide to Drug Development: A Comprehensive Review & Assessment


Guide to Drug Development: A Comprehensive Review & Assessment by Bert Spilker offers comprehensive review of the principles and activities involved in developing new drugs, devices, and other medical products. The book covers many topics not discussed in any other textbook and includes timely discussions on electronic clinical trials, registries of clinical trials, data mining, computer simulations and modeling, and changing regulatory standards.

Each chapter includes practical tips, lessons, guides, firsthand stories, quotes from experts, and three to six questions for group discussion. The last three chapters present twelve case studies each on clinical trials, regulatory affairs, and management of drug development. It will be the standard reference text for everyone working on or studying drug discovery or development, in industry, academia, hospitals, government, and independent laboratories.

Representative excerpts from the text include trial design issues when the use of placebos is unethical.One of the reasons that using a placebo is unethical in some trials is that the IRB/EC wants to ensure that patients will not deteriorate physically. In this situation, it may be possible to inform the IRB that, if patients are randomized to placebo or active drug, then any patients who deteriorate when assessed at Day X will be dropped from the trial and given the standard therapy for their disease.

On the other hand, the issue may be that the IRB wants to go further and assure patients that they will improve and not simply remain stable. In this situation, the protocol can read that all patients will be assessed on Day X and any who have not improved by a predefined amount will be dropped from the trial. Both of these examples are referred to as fail-safe designs because anyone who fails to meet the standards at any clinic visit will be removed from the trial and placed on active therapy.

While where are some trials where additional sites are required to enroll more patients, it is often the last approach that should be considered because often there are other reasons for the lower-than-planned number of patients enrolled. This is mentioned because the author still hears from companies that want to add new sites to a trial as soon as they learn that recruitment is slower than desired, but they have not investigated the reasons for this situation. The primary principle is to identify the real cause(s) of the recruitment problem and to see whether the issue is the same at each site or varies from site to site.

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Drugs: From Discovery to Approval 2nd Edition, Rick Ng


Drugs: From Discovery to Approval 2nd Edition by Rick Ng introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. This textbook provides the reader with a high-level overview of the drug discovery process and the regulatory challenges facing the journey from drug molecule to marketplace.

The second edition of a book that offers a user-friendly step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of preclinical trials. This book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of preclinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products.

Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. This Second Edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter; Answers to Review Questions provided in an appendix; and carefully selected "mini" case studies in each chapter.

Richly illustrated throughout with over ninety figures and tables, this important new edition also includes helpful listings of current FDA and European guidelines and a special section on regulatory authority and processes in China. It is an indispensable resource for pharmaceutical industry and academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in drug development. It is also an excellent textbook for students in pharmacy, science, and medicine courses.

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