For more than three decades, millions of consumers have trusted The Pill Book to provide official, FDA-approved information on more than 1,800 of the most commonly prescribed drugs in the United States with guidelines from leading pharmacists. Each drug is profiled in a concise, readable, easy-to-understand entry, making The Pill Book the perfect reference when you have questions about the medications your doctor prescribes. Inside you’ll discover
• generic and brand-name listings that can help you save money
• What each drug is for, and how it works
• usual dosages, and what to do if a dose is skipped
• side effects and possible adverse reactions, highlighted for quick reference
• interactions with other drugs and food
• overdose and addiction potential
• alcohol-free and sugar-free medications
• the most popular self-injected medications and their safe handling
• information for seniors, pregnant and breast-feeding women, children, and others with special needs
• cautions and warnings, and when to call your doctor
• 32 pages of actual-size color photographs of prescription pills*
No home should be without this book!
*Not all ereading devices will show the images in color and at the exact size.
The most up-to-date information about the more than 1,800 most commonly prescribed drugs in the United States:
• Generic and brand-name listings that can help you save money
• What the drug is for, and how it works
• Usual dosages, and what to do if a dose is skipped
• Side effects and possible adverse reactions, highlighted for quick reference
• Interactions with other drugs and food
• Overdose and addiction potential
• Alcohol-free and sugar-free medications
• The most popular self-injected medications and their safe handling
• Information for seniors, pregnant and breast-feeding women, children, and others with special needs
• Cautions and warnings, and when to call your doctor
• 32 pages of actual-size color photographs of prescription pills
From the Trade Paperback edition.
DMSO is a natural chemical compound derived from trees as a by-product from paper manufacturing. DMSO has been called a new medical principle and a true wonder drug. It has proven effective, either by itself or in combination with other products in the treatment of nearly every ailment known.
There has been much controversy about DMSO over the last 50 years. It is one of the most studied medical products ever. Thousands of scientific articles have been written about DMSO. When used properly it is one of the safest products know. It is also very cheap to produce.
This book provides the documentation needed to show that DMSO is probably the most important product ever for the relief of human suffering.
******Archie is quite clearly a leading authorithy on DMSO. He has extensive knowledge and experience regarding the clinical benefits of DMSO treatment. For decades, Archie has studied and worked with DMSO. He understands the safety, utility and efficaciousness of DMSO. I highly recommend this book for anyone interested in health, especially for those who want to learn more about non toxic medical therapies. For individuals with certain health ailments, DMSO could prove quite benefical. -Daniel Junck, MD
Kratom and Other Mitragynines: The Chemistry and Pharmacology of Opioids from a Non-Opium Sourcepresents an introduction to the chemical and biological properties of alkaloids isolated from M. speciosa as well as their synthetic analogs. The book covers various topics including phytochemistry, medicinal chemistry, and pharmacology. Current research, analgesic effects, and addiction potential are also discussed. As the first extensive text on the basic science and clinical use of Kratom, the book provides readers with a concise yet comprehensive introduction to nature’s "other opioid."
This book of clinical pharmacology covers the science of drugs or pharmaceutical including their origin, composition, pharmacokinetics, mechanism of action, therapeutic use, side effects and toxicology with specific description of drugs followed by short headings makes it easy to understand and point-wise explanation of information. This clinical pharmacology book will be helpful for the medical students and practicing doctors.
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Important Notice: Media content referenced within the product description or the product text may not be available in the ebook version.
Presenting theoretical knowledge and applied practical considerations, this title
provides an in-depth discussion of recent advances in sterilization
identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions
explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results
blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions
Includes New and Updated Material
Now in its second edition, this work is the culmination of research and discussions with technical experts, as well as USP and FDA representatives on various topics of interest to the pharmaceutical microbiologist and those responsible for the microbial quality of products, materials, equipment, and manufacturing facilities. New in this edition is an entire chapter dedicated to the topic of biofilms and their impact on pharmaceutical and biopharmaceutical operations. The subject of rapid methods in microbiology has been expanded and includes a discussion on the validation of alternative microbiological methods and a case study on microbial identification in support of a product contamination investigation.
Substantially updated and revised, this book assists readers in understanding the fundamental issues associated with pharmaceutical microbiology and provides them with tools to create effective microbial contamination control and microbial testing programs for the areas under their responsibility.
From the Trade Paperback edition.
Developed for use at the point of care, Pharmacotherapy Bedside Guide helps you decide which pharmacotherapy to employ in specific clinical situations. Comprised exclusively of quick-hit tables and algorithms, this carryanywhere companion tells you what treatment the evidence suggests for each illness or disorder. It also details essential drug information, such as benefits, risks, adverse reactions, dosage, interactions with other drugs, and responses. Conveniently organized by specialty and disorder rather than drug, Pharmacotherapy Bedside Guide will prove invaluable when treating patients.
All these problems have been shielded from public scrutiny because they're too complex to capture in a sound bite. But Ben Goldacre shows that the true scale of this murderous disaster fully reveals itself only when the details are untangled. He believes we should all be able to understand precisely how data manipulation works and how research misconduct in the medical industry affects us on a global scale.
With Goldacre's characteristic flair and a forensic attention to detail, Bad Pharma reveals a shockingly broken system and calls for regulation. This is the pharmaceutical industry as it has never been seen before.
Miracle Medicines goes behind the scenes of the pharmaceutical industry and into the high-security laboratories to tell the stories of the men and women---chemists, physiologists, medical and clinical researchers, engineers---who have chosen to toil for years in the lab in order to transform scientific theories into new lifesaving medicines.
You’ll witness the day-to-day labors, victories and defeats of the dedicated professionals who are waging a war against the diseases that still plague mankind. From the confines of their laboratories, these pharmaceutical adventurers explore unknown territories in health and science.
Miracle Medicines reveals what really happens during the long and uncertain journey that each new drug and its creators must endure from theory, to research, to testing and, finally, FDA approval and delivery to the public. It’s a very human story within the context of fascinating scientific innovation.
Through first hand interviews you’ll also meet the patients who benefit from these manmade miracles and learn how, within their bloodstreams, an ongoing battle is raging. The drugs profiled are:Advair: GlaxoSmithKline’s revolutionary asthma medication, the first packaged as both a control and emergency drug.Gleevec: The Novartis’ chronic myeloid leukemia treatment born from decades of medical research in a field of study that was once considered hopeless.Humalog: Eli Lilly’s reinvention of insulin to control diabetes has been described as being better than natureLipitor: Pfizer’s miracle antidote for high cholesterol that was nearly lost to the pharmaceutical vaults and has since become the world’s top-selling medicine.Norvir: Abbott’s contribution to the fight against HIV that nearly erases all traces of the disease from the bloodstream and prolongs the life of patients.Remicade: Created for the treatment of Crohn’s disease, rheumatoid arthritis and other Immune Mediated Inflammatory Diseases, Johnson & Johnson’s revolutionary biomedicine was developed from technology that once was only found in science fiction.Seroquel: AstraZeneca’s treatment for both schizophrenia and bipolar mania that has given millions of psychiatrics a new lease on life.
This compelling and truth-revealing book will forever change the way you view the medicines in your medicine cabinet, and the people who create them.
Here, Dr. Mann, a nationally recognized hypertension specialist, identifies the drugs most likely to have side effects, and those that can be used in their place. He describes the shortcomings of some of the new drugs, while also introducing readers to some excellent old drugs that are woefully underused as a result of the publicity blitz surrounding the new, expensive ones. He emphasizes the importance of matching the medication and dosage to the individual who will be taking them, and presents the overlooked clues that can tell us who should be on which drug (even an excellent drug can be the wrong one if it is given to the wrong person or in the wrong dose). Hypertension and You is directed at the more than 50 million Americans (including a majority of people over the age of 60) who are taking blood pressure medication. Many patients suspect they might be on the wrong medication, but don’t know enough to be sure. This book shows how medications can be prescribed more wisely to achieve better results and gives patients the knowledge they need to capably discuss their medications with their health care providers.
Hypertension and You provides many ideas and approaches that will be new to readers, and also to many physicians, and which no other book offers. It’s the first book to make the case that something is terribly wrong with how doctors are prescribing drugs for this condition. It provides readers with better knowledge of the available medications, empowering them to work with their physician to get onto the medications that are right for them.
"These cards offer concise yet detailed case studies for students to review current pharmacotherapeutic options for many of the commonly encountered disease states....Students might find these cards to be a very helpful in addition to their therapeutics courses to help them retain knowledge through the use of real-life clinical scenarios. 3 Stars."--Doody's Review Service
These 238 Q&A cards provide a complete review of pharmacotherapeutic concepts for the major disease states most often encountered in practiceEmphasizes evidence-based therapeutic decision making and drug therapy monitoring Each card features a case and therapeutic question Key facts are included for the drug or drug class that correctly answers the question Case Notes explain the answer and include clinical pearls about use of the drug, management of the disease, and dosing
The authors offer a basic introduction to pharmacological concepts, embedded in specific conditions, through case studies and self-assessment questions. By utilising a case study approach, they enable the reader to link pharmacological concepts with clinical practice.
Many of the conditions presented will be seen across all healthcare settings. In addition, the comprehensive glossary and list of abbreviations will enable students to understand some of the more technical terms used in the British National Formulary (BNF) and other prescribing sources.
Reading this book, and carrying out the numerous self-assessment activities, will give the reader an appreciation of the value of having a sound pharmacological knowledge base in order to deliver safe practice, effective prescribing and improved patient care.
How the body affects drugs
How drugs affect the body
Types of adverse drug reactions and interactions
Understanding and using the British National Formulary
Chronic obstructive pulmonary disease
Incontinence in adults
Mental health problems
Complex health needs and polypharmacy
The challenges of non-medical prescribing
Water Insolubility is the Primary Culprit in over 40% of New Drug Development Failures
The most comprehensive resource on the topic, this second edition of Water Insoluble Drug Formulation brings together a distinguished team of experts to provide the scientific background and step-by-step guidance needed to deal with solubility issues in drug development. Twenty-three chapters systematically describe solubility properties and their impact on formulation, from theory to industrial practice. With detailed discussion on how these properties contribute to solubilization and dissolution, the text also features six brand new chapters on water-insoluble drugs, exploring regulatory aspects, pharmacokinetic behavior, early phase formulation strategies, lipid based systems for oral delivery, modified release of insoluble drugs, and scalable manufacturing aspects. The book includes more than 15 water-insoluble drug delivery systems or technologies, illustrated with case studies featuring oral and parenteral applications. Highlighting the most current information and data available, this seminal volume reflects the significant progress that has been made in nearly all aspects of this field.
Speed-Speed-Speedfreak traces the criminal and cultural use of amphetamine and its growing use through each new and destructive cycle. The book will be printed in rounded pill capsule form, like the vaunted “black beauty” of pharmaceutical history.
Mick Farren is the former lead singer of The Deviants and the author of more than forty books.
Experience with clinical cases is key to excelling on the USMLE Step 1 and shelf exams, and ultimately to providing patients with competent clinical care. Case Files: Pharmacology provides 56 true-to-life clinical cases that illustrate essential concepts in pharmacology. Each case includes an easy-to-understand discussion correlated to key basic science concepts, definitions of key terms, pharmacology pearls, and USMLE-style review questions. With Case Files, you'll learn instead of memorize.Learn from 56 high-yield cases, each with board-style questions Master key concepts with clinical pearls Polish your approach to clinical problems and to patient care Maximize your board scores with the proven Case Files system
Side Effects tells the tale of a gutsy assistant attorney general who, along with an unlikely whistle-blower at an Ivy League university, uncovered evidence of deception behind one of the most successful drug campaigns in history. Paxil was the world's bestselling antidepressant in 2002. Pediatric prescriptions soared, even though there was no proof that the drug performed any better than sugar pills in treating children and adolescents, and the real risks the drugs posed were withheld from the public. The New York State Attorney General's office brought an unprecedented lawsuit against giant manufacturer GlaxoSmithKline, the maker of Paxil, for consumer fraud. The successful suit launched a tidal wave of protest that changed the way drugs are tested, sold, and marketed in this country.
With meticulous research, Alison Bass shows us the underbelly of the pharmaceutical industry. She lays bare the unhealthy ties between the medical establishment, big pharma, and the FDA—relationships that place vulnerable children and adults at risk every day.
Whether you are a student or a practicing pharmacist seeking to improve your patient-care skills, Pharmaceutical Care Practice, 3e provides the step-by-step implementation strategies necessary to practice in this patient-centered environment. This practical guide to providing pharmaceutical care helps you to:Understand your growing role in drug therapy assessment and delivery Learn an effective process for applying your pharmacotherapeutic knowledge to identify and prevent or resolve drug therapy problems Establish a strong therapeutic relationship with your patients Optimize your patients’ well-being by achieving therapeutic goals Improve your follow-up evaluation abilities Documents your pharmaceutical care and obtain reimbursement Work collaboratively with other patient care providers
The patient-centered approach advocated by the authors, combined with an orderly, logical, rational decision-making process assessing the indication, effectiveness, safety, and convenience of all patient drug therapies will have a measurable positive impact on the outcomes of drug therapy.
—Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA
The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical "nuts and bolts" approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices.
Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events.
Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include:In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations.
Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites.
Your Baby’s Best Shot is written for the parent who does not have a background in science, research, or medicine, and who is confused and overwhelmed by the massive amount of information regarding the issue of child vaccines. New parents are worried about the decisions that they are making regarding their children’s health, and this work helps them wade through the information they receive in order to help them understand that vaccinating their child is actually one of the simplest and smartest decisions that they can make.
Covering such topics as vaccine ingredients, how vaccines work, what can happen when populations don’t vaccinate their children, and the controversies surrounding supposed links to autism, allergies, and asthma, the authors provide an overview of the field in an easy to understand guide for parents.
In an age when autism diagnoses remain on the rise, when a single infectious individual can help spark an epidemic in three countries, when doctors routinely administer an often bewildering array of shots, and when parents swear their babies were fine until their first dosage of the MMR, the authors hope this book will serve as a crucial resource to help parents understand this vitally important issue.
This Fifth Edition has been extensively updated to reflect current advances in understanding how the diet works, how it should be used, and the future role of the diet as a treatment. Six new chapters address how to integrate the diet into all cultures, religions, and taste preferences new information on modified and less restrictive versions of the diet, and the Modified Atkins Diet for Epilepsy are included. The book also covers exciting new research that shows the diet may work for people with other neurological illnesses.
This best-seller also includes sample meal plans, a food database, how to calculate foods, and much more.
A fun, fast way to learn essential information about the most popular over-the-counter medications and herbal supplements commonly sold in U.S. pharmacies.
Essential information about 100 of the most widely used over-the-counter medications and supplements available in the United States.
Each full-color card includes an illustration, clinical pearls, and tables and text detailing:Dosage Forms Common Self-Care Indications and Dosing Drug Characteristics Safety Issues Interactions Adverse Reactions Triage Criteria Self-Care Monitoring Parameters Key Patient Counseling Points
Development and use of robust analytical methods is critical for the ability to generate accurate analytical data. Sample preparation is an integral part of the analytical method. In a survey conducted by LC-GC1, responses indicated that approximately two-thirds of the time spent testing and analyzing samples was spent on the sample preparation portion of the method. In addition, issues related to sample preparation accounted for one-third of the errors generated while performing an analytical method.
A number of challenges exist in the sample preparation/extraction of pharmaceutical dosage forms for potency and purity analysis as well as isolation and identification of impurities and degradants. These challenges increase for complex dosage forms such as some controlled release formulations and other challenging formulations such as suspensions, ointments, transdermal patches, etc. Challenges in developing rapid and rugged sample preparation methods include complete dispersion of the dosage form to facilitate extraction and solubilization of the analytes of interest, dealing with extracted interfering components and addressing drug-excipient interactions. A number of factors must be considered and addressed in each of these areas.
The objective of Sample Preparation of Pharmaceutical Dosage Forms is to provide an overview of the various sample preparation and extraction techniques available for pharmaceutical dosage forms. In addition to the review and discussion of specific techniques, sample preparation method development and trouble shooting strategies are discussed. Multiple examples and case studies are presented to highlight various potential issues and solutions.
Why medicines often fail to produce the desired result and how such failures can be avoided
How to think about drug product safety and effectiveness
How the main participants in a medications use system can improve outcomes and how professional and personal values, attitudes, and ethical reasoning fit into drug therapy
What a properly designed and managed medications use system would look like — specific components, how the components fit together into a system, and how the system can be maintained and improved
Ways to evaluate medications use systems, how to recognize ineffective systems operations, how to identify missing system components and how to correct them
How the environment of medications use affects systems operations and patient outcomes, and why standards must change to improve drug safety and effectiveness
Drug-related illnesses and complications cost the health care system billions of dollars each year. Medical errors account for approximately 100,000 deaths each year, and drugs are the most common cause of medical errors in hospitals. Synthesizing research studies from seven nations, Preventing Medication Errors and Improving Drug Therapy Outcomes: A Management Systems Approach explores medications use from a social perspective. It identifies and describes the preventable adverse outcomes of drug therapy, discusses the safety, cost-effectiveness, and quality of medications use from a management systems perspective, and proposes systematic solutions.
This second edition of the Handbook of Poisonous and Injurious Plants is created to assist the clinician in the initial response to the needs of a child or adult exposed to a poisonous or injurious plant. It lists common plants that might lead to the development of the symptom complex and describes the mechanisms of action of the implicated toxin, additional clinical manifestations, and specific therapeutics for each presentation. It has methodically enhanced the previous edition’s botanical rigor with insights from both pharmacognosy and clinical medicine to make it a truly comprehensive source.
With its thorough references and full-color photos of hundreds of potentially toxic and injurious plants inside the home, anyone who has an interest in plants will find this book useful outside in the garden or out in the wild.
This book will fascinate botanists, horticulturists, and naturalists as well as hikers, gardeners, and all those who simply enjoy the wonders of nature and the great outdoors!
With Foreword by Lewis R. Goldfrank, MD and Introduction by Andrew Weil, MD
This book provides an extensive reference on the biology of marijuana and the role of molecular techniques in elucidating neuropharmacological aspects of cannabinoid receptors and the endogenous compounds that act upon them. Contributions from experts from around the world describe the interaction of cannabinoids and endocannabinoids on a wide range of biological functions including movement, memory and learning, pain, emotions, endocrine functions and many more. The Biology of Marijuana: From Gene to Behavior will be of interest to all scientists and clinicians interested in the biological effects and pharmacology of this drug.
This multi-authored book, comprising chapters from the best of clinicians, researchers and policymakers, is the essential guide to increasing the relevance and effectiveness of methadone treatment. Like it or loathe it, Methadone Matters.
A Doody's Core Title for 2017!
Pharmacotherapy Handbook provides the critical information you need to make drug therapy decisions for more than 140 diseases and disorders commonly encountered in a clinical setting. Featuring a convenient alphabetized presentation, this handy guide utilizes text, tables, figures, and treatment algorithms to make important drug data readily accessible and easily understood.
Features:Consistent chapter organization includes: Disease state definition Concise review of relevant pathophysiology Clinical presentation Diagnosis Goals of treatment Treatment Monitoring Six appendices, including "Allergic and Pseudoallergic Drug Reactions" and "Geriatrics" The ideal companion to Pharmacotherapy: A Pathophysiologic Approach, Ninth Edition by Joseph DiPiro, et al
Filling the void, Biotechnology Operations: Principles and Practices reflects this integrative philosophy, serving as a practical guide for students, professionals, or anyone else with interests in the biotech industry. Although many books emphasize specific technical aspects of biotech, this is perhaps the first to integrate essential concepts of product development and scientific and management skills with the seven functional areas of biotechnology:
Biomanufacturing Clinical trials Nonclinical studies Project management Quality assurance Quality control Regulatory affairs
A practical roadmap to optimizing biotechnology operations, this reference illustrates how to use specific product planning, design, and project management processes to seamlessly merge plans and efforts in the key functional areas. Applying lessons learned throughout the nascent history of biotech, author Michael Roy highlights developmental principles that could bring future products to market more safely and efficiently. Drawing from his experiences working in industry and teaching a graduate course at the University of Wisconsin, this hotly anticipated book clarifies basic methodologies and practices to help reduce risks and resolve problems as future technological discoveries are developed into tangible products.
This volume provides formulas and procedures for determination of sample size required not only for testing equality, but also for testing non-inferiority/superiority, and equivalence (similarity) based on both untransformed (raw) data and log-transformed data under a parallel-group design or a crossover design with equal or unequal ratio of treatment allocations. It contains a comprehensive and unified presentation of statistical procedures for sample size calculation that are commonly employed at various phases of clinical development. Each chapter includes, whenever possible, real examples of clinical studies from therapeutic areas such as cardiovascular, central nervous system, anti-infective, oncology, and women's health to demonstrate the clinical and statistical concepts, interpretations, and their relationships and interactions.
The book highlights statistical procedures for sample size calculation and justification that are commonly employed in clinical research and development. It provides clear, illustrated explanations of how the derived formulas and/or statistical procedures can be used.
Unfortunately, this has not eradicated reflux disease. It has just changed its nature. While heartburn, ulceration and strictures have become rare, reflux-induced adenocarcinoma of the esophagus is becoming increasingly common. Adenocarcinoma of the esophagus and gastric cardia is now the most rapidly increasing cancer type in the Western world.
The increasing incidence of esophageal adenocarcinoma has created an enormous interest and stimulus for research in this area. GERD brings together a vast amount of disparate literature and presents the entire pathogenesis of reflux disease in one place. In addition to providing a new concept of how gastroesophageal reflux causes cellular changes in the esophagus, GERD also offers a complete solution to a problem that has confused physicians for over a century. Both clinical and pathological information about reflux disease and its treatment are presented. GERD is meant to be used as a comprehensive reference for gastroenterologists, esophageal surgeons, and pathologists alike.Outlines how gastroesophageal reflux causes cellular changes in the esophagusBrings together the pathogenesis of the disease in one source and applies it toward clinical treatmentTom DeMeester is THE leading international expert on reflux disease; Parakrama Chandrasoma is one of the leading pathologists in the areaBook contains approximately 350 illustrationsAncillary web site features color illustrations: www.chandrasoma.com
Detailed calculation steps, useful comments, and mathematical hints enhance solved problems throughout...
Encouraging the use of the Ratio Method, the author draws attention to its applicability to a wide variety of biochemistry problems with logical consistency and intuitive ease. This entirely revised and updated second edition introduces three new chapters with coverage of laboratory-oriented calculations and data presentation, calculations relating to the emerging techniques in DNA and molecular biology, and applying the Ratio Method to pharmaceutical calculations.
New edition adds questions and extra tips in every chapter to help students perform biochemical calculations on their own!
By strengthening their understanding of mathematical logic and problem solving skills, Fundamentals of Biochemical Calculations, Second Edition enables students and biochemists to explore a wider range of real-world applications with the ability to tackle increasingly complex problems in biochemistry and related fields.
* Presents new perspectives on acute neuroemergency clinical trials
* Includes insights from clinical pharmacology and industry perspectives
* Discusses historical lessons learned from early and recent trials in acute neuroscience populations
Neurophysiology in Neurosurgery is a valuable educational tool that describes the theoretical and practical aspects of intraoperative monitoring through example. The authors provide in-depth descriptions of the most advanced techniques in intraoperative neurophysiological monitoring and guidelines for the management of neuroanesthesia during MEP monitoring.
The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.
This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed.
The book is organized into six highly practical segments:Part I: CTD, eCTD, Module 1, and Environmental Risk Assessment Part II: CTD Summaries Part III: Quality Topics Part IV: Nonclinical Topics Part V: Clinical Topics Part VI: Other Topics (including drug-device combination products)
This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan.
In this volume, the authors provide an authoritative account of the taxoids. it covers their production and biosynthesis - from commercial cultivation to plant tissue culture methods - describes taxoid chemistry, the analytical methods for identifying their structure and the pharmacological and pre-clinical aspects important in investigating their therapeutic actions.
It presents a thorough review of the scientific literature, including data from scientists currently engaged in taxoid research, and will be of significant value to researchers and others who wish to gain a practical perspective on taxoid research and development.