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Tuesday, January 11, 2011

Preclinical Drug Development, Second Edition

SBN: 9781420084726, 1420084720
Size: 7 x 10
Pages: 384
Volume: 187
Series: Drugs and the Pharmaceutical Sciences
Edition: Second
Pub Date: October 2009

An essential resource for medicinal chemists, biologists, and any specialist involved in the drug development sciences. Discussing the A to Z’s of preclinical drug development, this text includes the latest industry trends and regulatory expectations and requirements. Recent cases studies and drug development simulation methods are included to illustrate emerging techniques and strategies.

New chapters cover:

• pharmacokinetics
• modeling and simulation
• formulation and routes of administration
• toxicity evaluations
• assessment of drug absorption and metabolism
• interspecies scaling

Updated topics include:

• lead molecule selection and optimization via profiling
• screening using in silico and in vitro toxicity evaluations
• preclinical pharmacokinetic-pharmacodynamic modeling
• International Conference on Harmonization preclinical guidelines
• experimental methods for studying membrane drug transport

New Drug Approval Process, 5th edition

Book Specifications

Available to Purchase
Published: June 2009
ISBN: 9781420088496
eISBN: 9781420088502
Fifth Edition
552 pages
Format: Hardcover
Size: 6" x 9"
80 Black and White Illustrations

Quick Overview

This book will provide insight into applying research and regulatory capabilities to new pharmaceutical product approvals for increased efficiency and speed to market.

Gain insight into applying research and regulatory capabilities to new pharmaceutical product approvals for increased efficiency and speed to market.

STEP-BY-STEP GUIDELINES on developing and submitting the research and documentation that worldwide agencies require for product approval helps minimize errors and saves valuable time
CONTRIBUTIONS FROM 20 INTERNATIONAL THOUGHT LEADERS provides practical approaches to resolving problems that might occur during product development, with the full benefit of their years of successes and failures
UPDATES ON GLOBAL CHALLENGES that affect bringing new pharmaceutical products to market and changes that will have a tremendous influence on how new products are researched and marketed offers valuable advice to all who are involved in the drug development process

Dermatotoxicology, 6th edition

Publisher: CRC

Number Of Pages: 1232

Publication Date: 2004-02-25

Sales Rank: 1340630

ISBN / ASIN: 0415288622

EAN: 9780415288620

Binding: Hardcover

Manufacturer: CRC

Studio: CRC

Quote:

Book De******ion:

For twenty-five years, Dermatotoxicology has stood as the definitive reference book in the field. A generation of toxicologists and dermatologists has consulted this volume throughout their careers, finding within it a wealth of theoretical and practical guidance. Updated and expanded to reflect the latest developments in skin toxicology, Dermatotoxicology, Sixth Edition includes fundamental information on the mechanisms of action of toxic substances on the skin, as well as practical information on the various methods to evaluating dermal toxicity. It is unparalleled in its coverage, and this new edition broadens its scope to include chapters on: * Barrier Creams * Cosmetic Reactions * UV Radiation Exposure * Electron Paramagnetic Resonance * Powdered Human Stratum Corneum * Iontophoresis * Permeability of Skin for Metal Compounds * Current Trends in Skin Cancer Research * Tape Stripping Method v. Stratum Corneum * Hazardous Substances from Soil and Water
* Isolated Perfused Porcine Skin Flap * Physiologically-based Pharmacokinetic Models This completely revised and reworked edition constitutes a major contribution to the field of dermatotoxicology. Presenting the most modern concepts and methods in use today, researchers and clinicians will find this an invaluable resource time and time again.

Monday, January 10, 2011

Animal Models in Toxicology, Second Edition

Animal Models in Toxicology, Second Edition

Animal Models in Toxicology, Second Edition

Animal Models in Toxicology, Second Edition

By Shayne C. Gad, Gad Consulting Services, Cary, North Carolina, USA

Book Specifications

Available to Purchase
Published: Oct-06
ISBN: 9780824754075
Second Edition
952 pages
Format: Hardcover
Size: 7" x 10"
33 Black and White Illustrations

Quick Overview

Reflecting a decade's worth of changes, this Second Edition is a practical guide to the common statistical problems encountered in toxicology and the methodologies that are available to solve them.

Reflecting a decade's worth of changes, this Second Edition is a practical guide to the common statistical problems encountered in toxicology and the methodologies that are available to solve them.
The book presents a historical review of the use of animal models used in toxicology and an overview of broad considerations of metabolism and its relevance.
Chapters covering the eight major species used in toxicology and experimental biology form the core of the book. With contributions from experts in toxicology, toxicological pathology, and species-specific metabolism, each of these chapters provide an excellent introductory course along with guidance to the literature for more detailed understanding.

Features:

provides tables of normative physiology, pathology, reproductive, clinical laboratory, and metabolism data
presents detailed discussions of husbandry, major diseases, and handling for the major species used in toxicology and experimental biology
contains detailed descriptions and illustrations for dosing, blood collection, and other procedures
reviews current laws and regulations governing animal care and use in major countries
includes extensive appendices of acronyms, regulatory and scientific Web sites, animal suppliers, and a lexicon of terms used in describing clinical signs

Poisoning and Toxicology handbook, FOURTH EDITION

Description

Poisoning and Toxicology Handbook Fourth Edition Poisoning and Toxicology Handbook Leiken

Author:

Publisher: Informa HealthCare (2007)

Binding: Hardcover, 1384 pages

pricer: $199.95

ISBN-10: 1420044796

editorialreviews

A unique reference containing detailed reviews of more than 900 drugs and poisons, the Poisoning and Toxicology Handbook, Fourth Edition provides the latest information on medicinal, biological, herbal, and non-medicinal agents, and antidotes. Increasing its depth and scope with analyses of newer drugs, chemicals, and environmental toxins, including drugs that have been recently approved by the FDA, the book is a compendium of useful resources. Organized into seven sections, the book provides locations and phone numbers of poison control centers throughout the country, organizations offering information on toxicology, and teratology information services. It presents diagnostic testing and analytical procedures, evaluates the effectiveness of antidotes, and features an extensive symptoms index. The section on special topics provides detailed treatment protocols, hospital preparedness guidelines, and position statements and practice guidelines focused on the treatment of toxicities. This fourth edition keeps you up to date in one of the most exciting and expanding fields in medical science.

Handbook of Analytical Separations

Bioanalytical Separations is volume 4 of the multi-volume series, Handbook of Analytical Separations, providing reviews of analytical separation methods and techniques used for the determination of analytes across a whole range of applications. The theme for this volume is bioanalysis, in this case specifically meaning the analysis of drugs and their metabolites in biological fluids.

- Discusses new developments in instrumentation and methods of analyzing drugs and their metabolites in biological fluids

- Provides guidance to the different methods, their relative value to the user, and the advantages and pitfalls of their use

- Future trends are identified, in terms of the potential impact of new technologies.

Antimicrobial Susceptibility Testing Protocols

Antimicrobial Susceptibility Testing Protocols
edited by Richard Schwalbe

Antimicrobial Susceptibility Testing Protocols provides a comprehensive, up-to-date procedural manual that can be used by a wide variety of laboratory personnel. It includes protocols for bioassay methods and molecular methods for bacterial strain typing.

Antimicrobial Susceptibility Testing Protocols provides an integrated resource for updated lab-based techniques and charts within the contextual role of clinical microbiology in modern medicine.

Features:

Utilizes a user-friendly, editorial style to explain tests and provide step-by-step instructions

Offers clear procedural methods for use as a bench manual for laboratory personnel

Explains procedures for standard and non-standard tests and protocols

Describes the interaction between infectious disease physicians and laboratory personnel

Includes a table of antibiotic classes and common bug-drug susceptibilities

Offers extensive references at the end of each chapter to provide additional sources of information for investigating specific topics in greater detail

Part One introduces basic susceptibility disciplines including disk diffusion, macro and microbroth dilution, agar dilution, and the gradient method. It covers step-by-step protocols with an emphasis on optimizing the detection of resistant microorganisms.

Part Two describes specialized susceptibility protocols such as surveillance procedures for detection of antibiotic-resistant bacteria, serum bactericidal assays, time-kill curves, population analysis, and synergy testing.

Part Three is designed to be used as a reference resource. Chapters cover antibiotic development; design and use of an antibiogram; and the interactions of the clinical microbiology laboratory with the hospital pharmacy, and infectious disease and control.

Contents

An Overview of the Clinical and Laboratory Standards Institute and its Impact on Antimicrobial Susceptibility Testing

Antimicrobial Classifications: Drugs for Bugs

Disk Diffusion Tests and Gradient Methodologies

Macro and Microdilution Methods of Antimicrobial Susceptibility Testing

Automated Systems: An Overview

Agar Dilution Susceptibility Testing

Antibiograms/Preventive Surveillance: A Continuum of Data Collection, Analysis, and Presentation

Anaerobe Susceptibility Testing

Antifungal Susceptibility Testing of Yeasts

Antifungal Susceptibility Testing of Filamentous Fungi

Susceptibility Testing of Mycobacteria

Methods for Determining Bactericidal Activity and Antimicrobial Interactions: Synergy Testing/Time-Kill Curves/Population Analysis

Serum Bactericidal Testing

Bioassay Methods for Antimicrobial and Antifungal Agents

Molecular Methods for Bacterial Strain Typing

Pharmacy and Microbiology: Interactive Synergy

Interactions Between Clinicians and the Microbiology Laboratory

Clinical Microbiology in the Development of New Antimicrobial Agents

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Tumor Models in Cancer Research

Progress in a given field is often dependent upon the development of appropriate, accurate models. In modern times, cancer research has been engaged in a focused search for such models for more than 50 years. The foremost problem in developing such models is that cancer is many, many diseases arising from nearly every tissue and metastasizing too many.

Tumor Models in Cancer Research

A major breakthrough for models in cancer research was the development of transplantable rodent tumors. Many of the early tumor lines were carcinogen-induced, but others arose naturally in elderly animals from inbred strains of mice. These syngeneic tumors grown in the inbred host of origin allowed reproducible tumor growth and reproducible response to anticancer agents to be achieved. These tumor lines also frequently allowed analysis of tumor metastasis in the host.

The mutual needs for as large an array as possible of tumor types and the expansion of true inbred strains of mice to carry these tumors led to the identification of mutant mice with characteristics of deficient immunity suitable for the growth of human tumors as xenografts. The most frequently used of these mutant mouse strains are nude mice and SCID mice. Human tumor xenograft models were established from the many human tumor cell lines developed in the 1970s and 1980s and from fresh tumor explants. Since techniques for genetic manipulation have become more routine, animals expressing “oncogenes” or missing “tumor suppressor” genes have been developed, allowing a new level of understanding of the process of malignancy and new models for testing anticancer agent efficacy. Through the use of these techniques for some diseases and targets, it has been possible to establish specific animal models.

about the book

Beverly A. Teicher and a panel of leading experts comprehensively describe for the first time in many years the state-of-the-art in animal tumor model research. The wide array of models detailed form the basis for the selection of compounds and treatments that go into clinical testing of patients, and include syngeneic models, human tumor xenograft models, orthotopic models, metastatic models, transgenic models, and gene knockout models. Synthesizing many years experience with all the major in vivo models currently available for the study of malignant disease, Tumor Models in Cancer Research provides preclinical and clinical cancer researchers alike with a comprehensive guide to the selection of these models, their effective use, and the optimal interpretation of their results.

Principles of Organic Medicinal Chemistry

The book Principles of Organic Medicinal Chemistry describes the principles and concepts of chemistry, synthetic schemes, structure activity relationships, mechanism of action and clinical uses of carbon compounds in the light of modern trends. The book covers the syllabi of B.Pharmacy and M.Pharmacy courses of all Indian Universities.

This book comprises of 22 chapters. Chapter 1 gives an introduction to medicinal chemistry, Chapter 2 explain about the basics on principles of drug action and physicochemical properties of organic medicinal, substances are elaborated in Chapter 3. The concepts of Prodrugs and Drug metabolism are summarized in Chapter 4 and Chapter 5 respectively. Chapter 6 to Chapter 22 explains chemistry, properties, mechanism of action, structure activity relationships, chemistry of newer drugs and clinical uses of various therapeutic agents. At the end of book, a set of more than 200 essays and short questions and 225 objective questions with answers are strategically designed.

Drug-Drug Interactions, Second Edition

Helping researchers predict drug interactions in a more accurate and effective manner, this comprehensive volume covers every critical aspect of metabolism-based drug-drug interactions, including preclinical, clinical, toxicological, regulatory, and marketing perspectives by renowned thought leaders in their respective fields. Thoroughly updated, the Second Edition reflects key developments in the field, including an improved understanding of the relationship between transporters and enzymes in drug metabolism and drug interactions. Formatted to benefit the reader, this source provides helpful case examples, representative enzyme systems, and computer-aided modeling, as well as 200 valuable tables, equations, drawings, and photographs to clarify key concepts.

Clinical Trials - A Practical Guide to Design, Analysis, and Reporting

This book is a friendly jargon buster, which aims to demystify clinical trials. It is divided into five sections: fundamentals of trial design, alternative trial designs, basics of statistical analysis, special trial issues in data analysis, and reporting of trials. Using simple language the book explains with illustrations of numerous trial examples, the conceptual and methodological issues that occur at all stages of clinical trial covering trial design, conduct, analysis and reporting. The book is an educational and approachable reference in a difficult area of medicine where clinicians often feel uncertain and this material helps them review, appraise and publish trials and clinical evidence. The audience for the book includes physicians, statisticians, pharmacists, medical students, clinical researchers, medical writers, data managers, study co-ordinators, pharmaceutical sales representatives, and financial (medical) analysts.

Data Monitoring in Clinical Trials: A Case Studies Approach

Randomized clinical trials are the gold standard for establishing many clinical practice guidelines and are central to evidence based medicine. Obtaining the best evidence through clinical trials must be done within the boundaries of rigorous science and ethical principles. One fundamental principle is that trials should not continue longer than necessary to reach their objectives. Therefore, trials must be monitored for recruitment progress, quality of data, adherence to patient care or prevention standards, and early evidence of benefit or harm. Frequently, a group of external experts, independent from the investigators and trial sponsor, is charged with this monitoring responsibility, especially for safety and early benefit. This group is referred to by various names, such as a data monitoring committee or a data and safety monitoring board. This book, through a series of case studies presented by many distinguished clinical trial experts, illustrates the complexity of this monitoring process. The editors provide an overview of the process and a summary of a multitude of the lessons learned from the cases presented.

This book should be useful to anyone serving on a data and safety monitoring board, or planning to do so, for colleagues in academia, industry and governmental agencies, and for teaching students in biostatistics, epidemiology, clinical trials and medical ethics. No other text has as extensive a collection of cases which provide insight into the many issues, often conflicting, that must be examined before recommendations to continue or discontinue a trial can be made. While depth in statistical methods is not required, some familiarity with statistical design and analysis issues in clinical trials is helpful. The cases cover trials which were terminated early for convincing evidence of benefit, or for harmful effects. Cases with complex issues are also included. This series of cases should provide broad background information for potential monitoring committee members and better prepare them for the challenges that may exist in the trials for which they are responsible.

The three editors have contributed two overview chapters as well as several case studies to go along with cases contributed by a distinguished group of colleagues experienced in the design, monitoring and analysis of clinical trials. Dr. David DeMets is currently Professor and Chair, Department of Biostatistics and Medical Informatics at the University of Wisconsin-Madison. He is past president of the Eastern North American Region (ENAR) of the International Biometric Society, a past member of the Board of Directors of the American Statistical Association and an elected Fellow. He recently received the Robert Gordon Lectureship Award, given by the National Institutes of Health, for significant contributions to the field of clinical trials. Dr. Curt Furberg, is currently Professor (and former Chair) of the Department of Public Health Sciences at Wake Forest University. Previously, he was Head of the Clinical Trials Branch and Associate Director of the Clinical Applications and Prevention Program at the National Heart, Lung, and Blood Institute. Dr. Lawrence Friedman is a former Director of the Division of Epidemiology and Clinical Applications and a former Assistant Director for Ethics and Clinical Research at the National Heart, Lung, and Blood Institute. All three are past presidents of the Society of Clinical Trials. The editors have collaborated previously as coauthors of a text: the Fundamentals of Clinical Trials.

Statistics Applied to Clinical Trials

The previous two editions of this book, rather than being comprehensive, concentrated on the most relevant aspects of statistical analysis. Although well-received by students, clinicians, and researchers, these editions did not answer all their questions. This updated and extended edition serves as a more complete guide and reference text to students, physicians, and investigators, and, at the same time, preserves the common sense approach to statistical problem-solving of the previous editions.

In 1948 the first randomized controlled trial was published by the English Medical Research Council in the British Medical Journal. Until then, observations had been uncontrolled. Initially, trials frequently did not confirm hypotheses to be tested. This phenomenon was attributed to little sensitivity due to small samples, as well as inappropriate hypotheses based on biased prior trials. Additional flaws were being recognized and, subsequently were better accounted for: carryover effects due to insufficient washout from previous treatments, time effects due to external factors and the natural history of the condition under study, bias due to asymmetry between treatment groups, lack of sensitivity due to a negative correlation between treatment responses etc. Such flaws mainly of a technical nature have been largely implemented and lead to trials after 1970 being of significantly better quality than before. The past decade focused, in addition to technical aspects, on the need for circumspection in planning and conducting of clinical trials. As a consequence, prior to approval, clinical trial protocols are now routinely scrutinized by different circumstantial organs, including ethic committees, institutional and federal review boards, national and international scientific organizations, and monitoring committees charged with conducting interim analyses. The present book not only explains classical statistical analyses of clinical trials, but also addresses relatively novel issues, including equivalence testing, interim analyses, sequential analyses, meta-analyses, and provides a framework of the best statistical methods currently available for such purpose. This book is not only useful for investigators involved in the field of clinical trials, but also for students and physicians who wish to better understand the data of trials as published currently.

Drug Products for Clinical Trials: An Intl Guide to Formulation, Production, Quality Control

This practical guide shows how the appropriate use of clinical materials can increase efficiency in bringing new products to the marketplace;offering authoritative assessments of the scientific and legal issues involved in the successful completion of clinical trials for marketing approval by regulatory agencies. The only wide-ranging, up-to-date book of its kind available on the subject! Describing both the science and management of product development, Drug Products for Clinical Trials furnishes effective approaches for preclinical drug discovery addresses the function of the clinical trials materials manager covers the design of clinical protocols in developing a new chemical entity (NCE) explains the importance of bioequivalence between clinical trials materials and final products demonstrates rapid, reliable processes for clinical evaluation discusses the interaction between clinical research, manufacturing, and packaging reviews quality control strategies used in the manufacture of drug substances for clinical studies conducted throughout the world and much more!

Basic & Clinical Pharmacology

The current science of pharmacology-and its clinical applications-at your fingertips

Now in its 25th year of publication, Basic and Clinical Pharmacology is the most up-to-date and complete pharmacology textbook available. Through nine previous editions it has set the standard for concise and easy-to-read, yet comprehensive coverage of pharmacology. The text's integration of basic with clinical science makes it well suited for an integrated organ-system-based curricula as well as the more traditional curricula.

Features

In-depth coverage of key pharmacology topics, from basic principles to pharmacologic considerations for autonomic, cardiovascular-renal, smooth muscle, CNS, endocrine, antimicrobial, and chemotherapeutic and immunotherapeutic drugs

Updated with dozens of new, recently approved drugs, including monoclonal antibodies

Detailed review of the mechanism of action and toxicities of traditional and newer drugs

Critical discussions of treatment strategies and recommended drugs for all major diseases

Valuable section on toxicology that provides an introduction to occupational and environmental toxicology; heavy metal intoxication and chelators; and management of the poisoned patient

Ready-to-use, study-enhancing features, including special interest boxes, lists of common preparations, and dosage information

Unique evidence-based chapters on abused drugs; special aspects of perinatal, pediatric, and geriatric pharmacology; and over-the-counter drugs, herbal medications, and nutritional supplements

More than 500 concept-clarifying illustrations and tables throughout

Sunday, January 9, 2011

Pharmacotherapy Handbook

The second edition of the Pharmacotherapy Handbook provides readers with a portable, readable guide that is integral to any clinical setting. Bold-face type highlights drug names when they first appear and in all closing information. The book's bulleted format helps readers find the information they need immediately. This updated book was designed as a companion text for the fourth edition Pharmacotherapy: A Pathophysiologic Approach.

Pharmacotherapy Handbook 7th Ed.

Essential Pharmacotherapy Data at Your Fingertips!

Pharmacotherapy Handbook delivers the essential information you need to quickly and confidently make drug therapy decisions for eighty-four diseases and disorders. Featuring a convenient alphabetized presentation, the book utilizes text, tables, figures, and treatment algorithms to make important drug data readily accessible and easily understandable.

Features:

Consistent chapter organization that includes:. Disease state definition,. Concise review of relevant pathophysiology,. Clinical presentation,. Diagnosis,. Desired outcome,. Treatment,. Monitoring

Six valuable appendices, including a new one on the management of pharmacotherapy in the elderly. NEW chapters on adrenal gland disorders and influenza. The ideal companion Pharmacology: A Pathophysiologic Approach, 7e by Joseph DiPiro et al.

Filtration and Purification in the Biopharmaceutical Industry, Second Edition

Expanded to include extensive new material on the critical role of purification and detailing the significant advances in filtration science and technology, this Second Edition of a classic reference provides state-of-the-science information on all aspects of filtration and purification, including current methods, processes, technologies, equipment, and the latest industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries.

New Drug Development: Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics

Highlighting key points from the latest regulatory requirements, this book helps those new to the world of pharmaceutical development understand regulatory steps, reduce cost by avoiding unnecessary trials, and attain guidance through each step of the drug approval process. This volume acquaints readers with procedures that determine the success of drug development projects with updated regulatory guidelines from the FDA and ICH, solutions to hurdles in application protocols, and recommendations from more than forty respected and experience officials from regulatory agencies around the globe. It covers topics related to the development of chiral drugs, liposomal products, and more.

Biopharmaceutics Applications in Drug Development

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.

Biopharmaceutics Applications in Drug Development 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.

Competition Law and Patents

In June 2005 the European Commission announced that it had fined AstraZeneca €60 million for misusing the patent system to delay entry of competitors thereby abusing its dominant position in contravention of Art. 82 EC. In October 2005 a complaint by six phone manufacturers was reported against Qualcomm, a chip manufacturer that owns patents over technology used in 3G handsets, alleging that Qualcomm refused to license essential patents on fair terms, and charged excessive royalties for its essential patents thereby acting anti-competitively. In December 2005 the Commission published a Discussion Paper on the Application of Art. 82 to Exclusionary Abuses. In February 2007 the Commission opened an investigation into Boehringer’s best selling drug last year, Spiriva, in relation to possible misuses of the patent system to exclude competition from the market.

Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition

Thoroughly acquainting the reader with freeze-drying fundamentals-including water properties critical to the process and mechanisms and means of protein stabilization-Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures-ensuring the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation.

Process Validation in Manufacturing Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies

Written by top authorities in process validation, this reference explores current trends in the field and strategies for selecting the most appropriate quality control scheme. It offers practical guidelines, recommendations, and an abundance of case studies that showcase various techniques and approaches in the validation of biopharmaceutical processes. These include guidance on determining the life spans of chromatography and filtration media, process characterization and techniques for scaling-down unit operations in biopharmaceutical manufacturing, examples of contamination events, and practical methods for testing raw materials and in-process samples during various manufacturing stages.

Clean-in-Place for Biopharmaceutical Processes

An invaluable source instruction on the principles, instrumentation, design, implementation, operation, and maintenance of an effective clean-in-place system (CIP), this guide illustrates best practices and successful applications of CIP in both pharmaceutical and biotechnology facilities. Offering reader-friendly descriptions of the various types of equipment and materials found in typical CIP processes, Clean-In-Place For Biopharmaceutical Processes will take the guess-work out of CIP development, and illustrate all one needs to know for the establishment and optimal functioning of a CIP system.

Drug Absorption Studies: In Situ, In Vitro and In Silico Models

In the last 15 years, a great number of cell- or tissue-based in vitro models have been introduced into the biopharmaceutics arena. These models mimic the different biological barriers that a drug has to overcome to finally reach its target organ/cell/receptor. These in vitro models have been found very useful in not only characterising the permeability behaviour of drugs molecules in epithelial and endothelial tissues, but also studying drug delivery systems for improved delivery and enhanced absorption. Compared to the complex in vivo situation, in vitro models offer a fast, convenient approach with cost advantages most of times. Most importantly, they can be standardised and automatised to be applicable to the high-throughput screening.

Starting at the molecular level of studies, continuing with cell monolayer models (both primary and cell lines) and in situ techniques as a final testing format, the book provides a practical approach to contemporary in vitro techniques for drug absorption studies. In addition, chapters on high-throughput assays, in vitro-in vivo correlation, bioinformatics and regulatory issues are covered, giving a comprehensive overview of available models and techniques. Moreover, an appendix comprised with a number of practical protocols is available online, updated as needed, should prove very helpful to apply the techniques directly to the benchside.

Modeling in Biopharmaceutics, Pharmacokinetics and Pharmacodynamics: Homogeneous and Heterogeneous Approaches

The state of the art in Biopharmaceutics, Pharmacokinetics, and Pharmacodynamics Modeling is presented in this book. It shows how advanced physical and mathematical methods can expand classical models in order to cover heterogeneous drug-biological processes and therapeutic effects in the body. The book is divided into four parts; the first deals with the fundamental principles of fractals, diffusion and nonlinear dynamics; the second with drug dissolution, release, and absorption; the third with empirical, compartmental, and stochastic pharmacokinetic models, and the fourth mainly with nonclassical aspects of pharmacodynamics. The classical models that have relevance and application to these sciences are also considered throughout. Many examples are used to illustrate the intrinsic complexity of drug administration related phenomena in the human, justifying the use of advanced modeling methods.

This timely and useful book will appeal to graduate students and researchers in pharmacology, pharmaceutical sciences, bioengineering, and physiology.

Encyclopedia of Biopharmaceutical Statistics, Second Edition

Millennium Pharmaceuticals, Cambridge, MA. Resource offers more than 3,300 lists expanded to reflect amendments to regulatory requirements and recently developed statistical methods impacting the drug review/approval process and biopharmaceutical research and development. Offers more than 3,000 equations, tables, and figures. Previous edition not cited.

Protein Mass Spectrometry, Volume 52

This book is designed to be a central text for young graduate students interested in mass spectrometry as it relates to study of protein structure and function as well as proteomics.
It is a definite must have work for:
- libraries at academic institutions with Master and Graduate programs in Biochemistry, Molecular Biology, Structural Biology and Proteomics;
- individual laboratories with interests covering these areas; and
- libraries and individual laboratories in the pharmaceutical and biotechnology industries.

. serves as an essential reference to those working in the field
. incorporates the contributions of prominent experts
. features comprehensive coverage and a logical structure

Development of Biopharmaceutical Parenteral Dosage Forms

This up-to-the-minute reference delineates;in a systematic fashion;the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products;covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications and more! Furnished with helpful references, tables, and drawings, this practical guide is indispensable for pharmaceutical, medicinal, and protein chemists; molecular biologists; process engineers; purification scientists; biopharmaceutical and pharmaceutical formulators and product developers; quality control, quality assurance, and regulatory compliance personnel; and upper-level undergraduate and graduate students in these disciplines.

Handbook of Prebiotics

In order to achieve optimal digestion, absorption, and nutritional health, we must have appropriate populations of positive microflora. Prebiotics are functional foods that improve health by fortifying indigenous probiotics within the gut. This fast-growing area of nutrition and microbiology is rapidly amassing data and answering many questions about the necessity and benefit of such functional foods.

Gathering contributions from leading experts in a range of disciplines,Handbook of Prebiotics presents a balanced view of the current knowledge in many different areas of the field. It discusses concept, definition and criteria for classification of a food component as prebioticsIt then describes interactions with gut microbiota. Highlighting varying levels of evidence and agreement, the book presents current arguments for and against prebiotic intake. Contributions discuss the biomechanics of prebiotics and their effects on immune status, serum lipid concentrations, mineral bioavailability, and satiety modulation. They consider the health implications of prebiotic intake such as reduced incidence of gastroenteritis and chronic pathogenic gut disorders, including intestinal cancers and inflammatory bowel diseases.

Providing well-rounded coverage, the book explores the varying effects of prebiotics in different populations and age groups such as infants and the elderly, as well as livestock and pets. The final chapters describe food avenues and the safety implications for prebiotic use. Spanning several disciplines including food science, nutrition, microbiology, biotechnology, and the health sciences, this seminal work makes a point to include sound research science and well-balanced views on the potential of prebiotics for promoting good health.

Validation of Toxicogenomic Technologies

Toxicogenomics has been described as a discipline combining ex-pertise in toxicology, genetics, molecular biology, and environmental health to elucidate the response of living organisms to stressful environ-ments. It includes the study of how genomes respond to toxicant expo-sures and how genotype affects responses to toxicant exposures. As the technologies for monitoring these responses rapidly develop, it is critical that scientists and regulators are confident that the technologies are reliable and reproducible and that the data analyses have been validated. To discuss these issues in a public forum, the Committee on the Validation of Toxicogenomic Technologies designed a workshop to consider the current practice and advances in the validation of toxicogenomic tech-nologies. The workshop focused on the technical aspects of validation, recognizing it as a prerequisite for considering other important issues, such as biological validation (e.g., validating the use of microarray “sig-natures” to describe a toxic effect).

Drug Delivery Systems, Second Edition

Drug delivery technologies represent a vast and vital area of Research and Development. The demand for innovative drug delivery systems continues to grow, and this growth continues to drive new developments. Building on the foundation provided by the first edition, Drug Delivery Systems, Second Edition covers the latest developments in both industry and academia. New in this edition: · Chapter focusing on novel technologies and their global outlook · Coverage of electronically controlled drug delivery · Macrocapsules and nanoparticles in drug targeting · Drug nanocrystals and other new delivery systems · Updated information on liposomes as carriers Written in a straightforward, clear, and concise manner, the author provides a global perspective on current and future advances and market opportunities. Drug Delivery Systems, Second Edition answers the need for comprehensive information in a single resource for anyone venturing into this area of drug development.

Clarke's Analysis of Drugs and Poisons, Third Edition

This practical manual and standard reference work provides an authoritative source of analytical data for drugs and poisons. It is intended for use primarily by scientists faced with identifying and quantifying these substances in body fluids, tissue samples and pharmaceutical and industrial products. This completely revised and updated new edition now comprises two volumes housed in a handy slipcase. Clarke's Analysis of Drugs and Poisons is an essential requirement for all forensic and crime laboratories, toxicologists, clinical pharmacology departments, poison information centres, pathologists, clinical toxicologists, hospital pharmacists and analytical chemists. Clarke's Analysis of Drugs and Poisons was previously published as Clarke's Analysis and Identification of Drugs.

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