Book Description
This book covers the regulatory process for getting pharmaceuticals, biologics, and medical devices approved. It examines the pertinent aspects of the Federal Food, Drug and Cosmetic Act as it applies to human drug and device development, research, manufacturing, and marketing. Topics include: the drug approval process, Current Good Manufacturing Practices, Good Clinical Practices, Quality System Compliance and the corresponding documentation requirements, and FDA inspection processes and enforcement options. Although many references exist on this subject, this one is written in a general prose style that makes it useful to both students and professionals.
Customer Reviews:
Great resource.......2007-02-03
This book will not teach you RA, but it will provide you a great reference as an RA professional.
Best Available Book for Regulatory Affiars.......2006-11-23
Best Available Book for Regulatory Affiars, November 22, 2006
Reviewer: H. Burgoyne (Watertown, MA United States) - See all my reviews
I am currently completing a Masters in Regulatory Affairs and throughout all of my classes, this has been the best source (other than the FDA website, which is most current) pertaining to US reg. affairs. Forget any Parexel books...this one actually has an index, making it easy to find the information you need. Not sure about medical devices, as I do not specialize in them, but for pharmaceuticals and biologics this book is pretty comprehensive. You are not going to get a more "layman's level" interpretation of regulations than this book. Regulations are part of the law, which is never easy to "translate". It is hard to incorporate regulations into a book , as they are constantly being updated, but this book does a pretty good job. I have used the book to develop presentations, study for exams and write papers. If you are interested in US Regulatory Affairs, this book is definitely worth the investment. The price seems high, but is comparable to other books with the same subject matter.
Doesn't adequately cover medical device regulation.......2006-08-31
Mostly this book covers (perhaps adequately) FDA regulation of the development and approval process of new drugs. These new drugs are (by and large) developed by huge drug companies who doubtless employ teams of lawyers in connection with their FDA submissions and regulatory compliance, and it is quite likely that nearly all involved in that process with such companies would find this to be a "lite" description of FDA drug regulations, and will have little use for this book. (Imagine a beer having only 10 calories, not the 90 or so found in Miller Lite.)
Many medical devices, on the other hand, are developed by small companies (such as my employer) and a "layman's level" description (as opposed to a legal treatise) of FDA medical device regulation would be very useful. Since "medical device" is in the title, I figured when buying this book that there would be coverage relating to all FDA regulations pertaining to medical devices. Its why I (or thankfully, my company) bought the book.
Ther coverage of medical devices is grossly inadequate. Only a small portion of the book treats (again "litely") FDA medical device regulation, and then it largely covers only the premarket approval process for medical devices and barely mentions (or doesn't even mention--I forget) FDA regulation of the manner in which medical devices may be distributed in the US.
Given the relatively high cost of this book, I expected more and was quite disappointed.
Book Description
Providing in-depth coverage of the procedures utilized by pharmaceutical companies for regulatory compliance, this reference describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States-standing alone as the only authoritative guide to address the complex web of regulatory requirements, application processes, and quality control issues influencing the pharmaceutical industry.
Book Description
Statistics show that out of five thousand compounds with initial promise, five will go into human clinical trials, and only one will become an approved drug. This tiny fraction illustrates the huge complexities involved in bringing a drug to market, a process that brings together scientific research, medical ethics, business, and various regulatory agencies.
Drugs-From Discovery to Approval presents a clear, step-by-step overview of the entire process. Using simple language, this comprehensive guide introduces basic concepts, then moves on to discuss disease target selection and the discovery processes for both small and large molecule drugs. Subsequent chapters explain preclinical studies, clinical trials, regulatory issues, good manufacturing practices (GMPs), and perspectives on the future. Coverage also includes:
* A helpful listing of current FDA and European guidelines
* A special section on regulatory authorities and processes in Japan and China
* Rich illustrations throughout, including more than ninety figures and tables
* Useful appendices on the history of drug discovery and development
* Representative examples of drug mechanisms in action
Written for professionals in the pharmaceutical industry, and readily accessible for students of pharmacy or medicine and others interested in drug discovery, Drugs-From Discovery to Approval represents a practical and approachable reference on this important process.
Download Description
Statistics show that out of five thousand compounds with initial promise, five will go into human clinical trials, and only one will become an approved drug. This tiny fraction illustrates the huge complexities involved in bringing a drug to market, a process that brings together scientific research, medical ethics, business, and various regulatory agencies.
Drugs: From Discovery to Approval presents a clear, step-by-step overview of the entire process. Using simple language, this comprehensive guide introduces basic concepts, then moves on to discuss disease target selection and the discovery processes for both small and large molecule drugs. Subsequent chapters explain preclinical studies, clinical trials, regulatory issues, good manufacturing practices (GMPs), and perspectives on the future.
Coverage also includes:
- A helpful listing of current FDA and European guidelines
- A special section on regulatory authorities and processes in Japan and China
- Rich illustrations throughout, including more than ninety figures and tables
- Useful appendices on the history of drug discovery and development
- Representative examples of drug mechanisms in action
Written for professionals in the pharmaceutical industry, and readily accessible for students of pharmacy or medicine and others interested in drug discovery, Drugs: From Discovery to Approval represents a practical and approachable reference on this important process.
Customer Reviews:
An easy way to understand a complex process.......2006-08-21
I work in an organization that supports advanced gene therapy research that may lead to new therapies for chronic and life threatening diseases, but I am not a scientist. As a communicator, I needed to understand the long and arduous journey from discovery to pre-clinical research, to FDA-approved clinical manufacturing, and to human clinical trials. This book was excellent in helping me understand both the research and the regulatory environment.
The author says it best in the introduction, "The intention of this book is to provide an overview about how a drug is discovered, the amount of and types of laboratory tests that are performed, and the conduct of clinical trials before a drug is ready to registered for human use." The author also fully explains the role of regulatory authorities in these processes.
The book includes chapters on:
Drug discovery
Drug development and preclinical studies
Clinical trials
Good Manufacturing Practice
You'll also learn about things like toxicology studies, pharmacodynamics, and pharmacokinetics, and Investigational New Drug applications. Although the book contains some technical discussions and exhibits, the author has a logical and easy-to-understand way of presenting the information.
If, like me, you need to get a better understanding of process of getting basic drug research to the market, this book is for you.
Broad coverage with little in-depth detail.......2006-05-08
This book is written to cover a broad range of topics related to the drug discovery and approval process. Since so many topics are covered, there is very little in-depth coverage on any particular topic. It's suitable people who don't have any serious scientific training or experience in the industry. If you are looking for a high-level overview, this is a good book. If you would like more detailed information about any specific topic, you should probably look elsewhere. Some of the explaintions are over simplied in order for the average reader to understand. Much of the material covered in the book can be found in much greater detail by visiting the fda site or googling for the code of federal regulations. But if you do not what the FDA is or what CFR stands for, this book is probably right for you.
Good overview of the drug development and regulatory process.......2006-02-01
This is a very clear and concise review of the drug development process as well as the regulatory issues. It is well organized and well written. It is not a "behind the scenes" nitty-gritty book, but will help anyone who wants to understand the process.
The mystery of biotechs and pharma explained.......2005-08-23
Very strong on detail and highly informative for the non-scientist interested in the pharmaceutical and bio-tech industry.
Although a slightly akward layout, it is well worth reading- and for the complete novice, infinitely rewarding the second time around.
Good Overview of Drug Approval Process.......2005-04-04
This book fills a needed hole in the books about the pharma/drug industry. It provides a concise review of the drugs from discovery to approval and details the various steps along the way, including discovery, clinical trials, manfacturing and approval. There is enough science to provide the necessary background but not so much that the non scientist would be overwhelmed. It is well illustrated with plenty of diagrams and outlines. Dr. Ng delivers on a summary which can be read by novice to intermediate who desires to know more about the process. I think this book is a must read for attorneys or business people who are looking to understand the drug approval process and are working in the industry. It is also up to date which is very important in this field, where regulations can change. Finally it covers both US and other countries, although its US coverage is better than its non US coverage. This is the only reason I did not give the book 5 stars.
I find this book a good personal reference in a short concise form and therefore recommend it.
Average customer rating:
|
Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healt
Manufacturer: Informa Healthcare
ProductGroup: Book
Binding: Hardcover
 General
| Science
| Subjects
| Books
General
| Algebra
| Pure Mathematics
| Mathematics
| Science
| Subjects
| Books
General & Reference
| Technology
| Science
| Subjects
| Books
Risks
| Technology
| Science
| Subjects
| Books
General
| Pharmacology
| Medicine
| Subjects
| Books
Pharmacy
| Pharmacology
| Medicine
| Subjects
| Books
General
| Pharmacology
| Medical
| Professional & Technical
| Subjects
| Books
Pharmacy
| Pharmacology
| Medical
| Professional & Technical
| Subjects
| Books
General
| Computers & Internet
| Subjects
| Books
General
| Industries & Professions
| Business & Investing
| Subjects
| Books
General
| Arts & Photography
| Subjects
| Books
All Titles
| Qualifying Textbooks - Fall 2007
| Stores
| Books
Arts & Photography
| Qualifying Textbooks - Fall 2007
| Stores
| Books
Business & Investing
| Qualifying Textbooks - Fall 2007
| Stores
| Books
Computers & Internet
| Qualifying Textbooks - Fall 2007
| Stores
| Books
Medicine
| Qualifying Textbooks - Fall 2007
| Stores
| Books
Professional
| Qualifying Textbooks - Fall 2007
| Stores
| Books
Science
| Qualifying Textbooks - Fall 2007
| Stores
| Books
Similar Items:
-
21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
ASIN: 0849318718 |
Book Description
The most comprehensive guide to computer validation currently available, this invaluable reference discusses good laboratory, clinical, manufacturing, and distribution practices and explains the latest regulatory developments for the US, European and other regulatory authorities. Practical examples and checklists appear throughout the book and the authors explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. He reviews over twenty case studies of different types of computer systems. Latest FDA and PIC/S developments concerning computer validation, electronic records and signatures, and process analytical technologies are included.
Amazon.com
Many Americans have wondered why prescription drugs have become so expensive while advertising for those drugs seems to grow exponentially. Former New England Journal of Medicine Editor Marcia Angell has some answers. The pharmaceutical industry, according to Angell, is fraught with corruption and doing a disservice to customers, the federal government, and to the medical establishment itself. In The Truth About the Drug Companies, Angell explains how a huge portion of the revenue generated by "Big Pharma" goes not into research and development but into aggressive marketing campaigns to sell their product. She describes how, even though the drug companies claim that it costs them an average of 802 million dollars per drug to develop new medicines, that figure is obscenely inflated since it factors in marketing as well as expected interest the company would have received had they invested the money in the open market. Meanwhile, Angell says, most of the R & D work is done by colleges and universities funded by the government. There are also problems with the drugs themselves, Angell indicates, since a majority are "me-too drugs", slightly modified versions of existing products which meant to address concerns of consumers most likely to spend money on pharmaceuticals. Thus, the market is filled with remarkably similar drugs to treat depression and high cholesterol while potentially life-saving medicines for diseases afflicting third-world countries are discontinued because they aren't profitable. In the books most damning passage, Angell tells of the high-priced junkets offered to doctors, ostensibly offered as educational opportunities that seem to constitute little more than bribes. The prognosis for reform is a grim one, Angell indicates, due to the massive cash reserves and lobbying efforts of "Big Pharma." Indeed, that lobby was hard at work trying to discredit her claims immediately upon the book's publication. But for anyone who's paid a pharmacy bill, The Truth About the Drug Companies is a fascinating read. --John Moe
Book Description
During her two decades at The New England Journal of Medicine, Dr. Marcia Angell had a front-row seat on the appalling spectacle of the pharmaceutical industry. She watched drug companies stray from their original mission of discovering and manufacturing useful drugs and instead become vast marketing machines with unprecedented control over their own fortunes. She saw them gain nearly limitless influence over medical research, education, and how doctors do their jobs. She sympathized as the American public, particularly the elderly, struggled and increasingly failed to meet spiraling prescription drug prices. Now, in this bold, hard-hitting new book, Dr. Angell exposes the shocking truth of what the pharmaceutical industry has become–and argues for essential, long-overdue change.
Currently Americans spend a staggering $200 billion each year on prescription drugs. As Dr. Angell powerfully demonstrates, claims that high drug prices are necessary to fund research and development are unfounded: The truth is that drug companies funnel the bulk of their resources into the marketing of products of dubious benefit. Meanwhile, as profits soar, the companies brazenly use their wealth and power to push their agenda through Congress, the FDA, and academic medical centers.
Zeroing in on hugely successful drugs like AZT (the first drug to treat HIV/AIDS), Taxol (the best-selling cancer drug in history), and the blockbuster allergy drug Claritin, Dr. Angell demonstrates exactly how new products are brought to market. Drug companies, she shows, routinely rely on publicly funded institutions for their basic research; they rig clinical trials to make their products look better than they are; and they use their legions of lawyers to stretch out government-granted exclusive marketing rights for years. They also flood the market with copycat drugs that cost a lot more than the drugs they mimic but are no more effective.
The American pharmaceutical industry needs to be saved, mainly from itself, and Dr. Angell proposes a program of vital reforms, which includes restoring impartiality to clinical research and severing the ties between drug companies and medical education. Written with fierce passion and substantiated with in-depth research, The Truth About the Drug Companies is a searing indictment of an industry that has spun out of control.
From the Hardcover edition.
Customer Reviews:
Your Life depends on this information.......2007-09-03
The media in general and the medical industry in particular do not want you (patient) to read and be informed about what you are being prescribed and the consequences. They also are dealing with symptoms instead of causes. Prevention is not in the medical dictionary terminology. Drugs do not heal! Drugs should be a short term interrupter and not a progression from one prescription to another and another. Pharmaceutical companies are gaining more political power through Federal legislation of Congress, which results show in company coffers. Read and be informed.
The truth isn't pretty.......2007-06-26
This excellent book which shines a bright spotlight on the industry. This is an industry which (mostly due to its actions) is ready to implode, and I fear that it may take us physicians right along with them.
a must read.......2007-05-13
The message is clearly spelled out in the first few chapters.American consumers need to be aware of how we are being ripped off by the drug industies.This is a must read and extremely well written
Careful what you put in your mouth!.......2007-05-06
At the same time people are dying from this disease, and that, Big Pharma maintains it's strangle hold on research in our Medical Schools, and the treatment of diseases. Why the Diabetes industry alone worldwide is a 4 billion dollar a day industry. Not to mention herpes, asthma, AIDS, cancer, and the like. The afore mentioned diorders are said to be incureable. Why? Well when research is geared to profit, and not a cure, one begins to understand why. No cures unless there is a profit to be made. So what if people die, it controls the population.
It has been more than 100 years or more since a real cure for a specific disease was discovered. There is more of a profit in making a crutch, than an actual cure. Because once that disease is cured there is then very little money to be made. We have diseases hanging around forever, and when they say there is no cure, they mean we have not made enough money from this disease. In short there is no profit in a cure. Profit is of main concern here. Not you or your family.
Ms. Angell has a blueprint or an inside look at the process of the how and why things are the way they are. Money, money, money. The Love of money is the root of all evil. Money before people. This book is an eye opener, and like the people who rang the bell before 9/11, if no one listens, no good can come from this book. Ms. Angell is giving us a look from the point of view of a former insider, and very well bares listening to. Read this book and become pro-active about the healthcare of you and your family.
She Bashes Pharma.......2007-03-09
This a an attck on big pharma and a well rounded one at that. In the end Angell proposes a plan to lessen the power of the pharma companies.
Book Description
The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
Average customer rating:
|
Introduction to Health Care Delivery: A Primer for Pharmacists
Manufacturer: Jones & Bartlett Publishers
ProductGroup: Book
Binding: Paperback
Health Care Delivery
| Administration & Policy
| Medicine
| Subjects
| Books
Hospital Administration
| Administration & Policy
| Medicine
| Subjects
| Books
Public Health
| Administration & Policy
| Medicine
| Subjects
| Books
Pharmacy
| Pharmacology
| Medicine
| Subjects
| Books
General
| Medicine
| Subjects
| Books
Health Care Delivery
| Administration & Medicine Economics
| Medical
| Professional & Technical
| Subjects
| Books
Hospital Administration
| Administration & Medicine Economics
| Medical
| Professional & Technical
| Subjects
| Books
Pharmacy
| Pharmacology
| Medical
| Professional & Technical
| Subjects
| Books
General
| Health, Mind & Body
| Subjects
| Books
All Titles
| Qualifying Textbooks - Fall 2007
| Stores
| Books
Medicine
| Qualifying Textbooks - Fall 2007
| Stores
| Books
Professional
| Qualifying Textbooks - Fall 2007
| Stores
| Books
ASIN: 0763732818 |
Book Description
Introduction to Health Care Delivery: A Primer for Pharmacists, Third Edition, offers a current and comprehensive picture of the U.S. health care delivery system while emphasizing the perspective of the pharmacy profession. Each chapter in the new edition of this practical text begins with a real-world case study that demonstrates the connection between the concepts reviewed and the pharmacist's role.
Book Description
At last! A real-world reference guide for clinical trial SAS programming, packed with solutions that programmers can apply to their day-to-day problems. Discover key techniques and tools available within Base SAS (including the macro language and PROC SQL), SAS/GRAPH, and SAS/STAT that can be used to resolve many common issues in working with clinical trial data. Organized to reflect the statistical programmer's work flow, this user-friendly text begins with an introduction to the working environment, then presents chapters on importing and massaging data into analysis data sets, producing clinical trial output, and exporting data. Valuable plug-and-play programming examples are provided throughout. Whether you're a novice seeking an introduction to SAS programming for the pharmaceutical industry or a junior-level programmer exploring new approaches to problem solving, you'll find a wealth of practical suggestions to help you sharpen your skills.
Customer Reviews:
Excellent book for a beginer.......2007-08-17
Excellent book.....explains in detail which could be understood very easily by any one with basic knowledge in SAS programming.....highly recommended for those who wants to pursue their SAS programming career in pharma industry
Excellent.......2007-05-25
This is the first time I personally bought a book from Amazon and found it extremly satisfying as far as the pricing, quality and the delivery of the product is concerned.
One of the very few good SAS Books.......2007-04-07
Just love the way this book is written! A must for every SAS user working in the Clinical Trials / Pharma industry!!!
The best book I ever bought..........2007-01-24
It is not easy to explain easy things easily, but this author is different. He knows how to say more in few words. I liked this book too much. It is easy to read, easy to understand, and easy to follow. Wish we had more writers like him.
Excellent Overview of Pharma Programming and Reporting.......2006-11-16
Based on input from someone who just got a job at a large pharma in Southern California, the material in the book is DIRECTLY relevant to programming and reporting in the industry. Future versions could be a bit more detailed, but again, as an overview it is excellent.
Average customer rating:
|
Analytical Chemistry in a GMP Environment: A Practical Guide
Jim Miller
Manufacturer: Wiley-Interscience
ProductGroup: Book
Binding: Hardcover
Analytic
| Chemistry
| Science
| Subjects
| Books
General
| Science
| Subjects
| Books
General
| Reference
| Science
| Subjects
| Books
Quality Control
| Industrial, Manufacturing & Operational Systems
| Engineering
| Professional & Technical
| Subjects
| Books
Analytic
| Chemistry
| Professional Science
| Professional & Technical
| Subjects
| Books
Clinical Chemistry
| Pathology
| Internal Medicine
| Medicine
| Medical
| Professional & Technical
| Subjects
| Books
General
| Pharmacology
| Medical
| Professional & Technical
| Subjects
| Books
Pharmacy
| Pharmacology
| Medical
| Professional & Technical
| Subjects
| Books
Chemistry
| Pharmacology
| Medical
| Professional & Technical
| Subjects
| Books
General
| Pharmacology
| Medicine
| Subjects
| Books
General
| Medicine
| Subjects
| Books
Clinical Chemistry
| Pathology
| Specialties
| Medicine
| Subjects
| Books
Reference
| Medicine
| New & Used Textbooks
| Stores
| Books
Nursing
| Medicine
| New & Used Textbooks
| Stores
| Books
Analytical
| Chemistry
| Sciences
| New & Used Textbooks
| Stores
| Books
All Titles
| Qualifying Textbooks - Fall 2007
| Stores
| Books
Medicine
| Qualifying Textbooks - Fall 2007
| Stores
| Books
Professional
| Qualifying Textbooks - Fall 2007
| Stores
| Books
Science
| Qualifying Textbooks - Fall 2007
| Stores
| Books
Similar Items:
-
Analytical Method Validation and Instrument Performance Verification
-
Analytical Method Development and Validation
-
Method Validation in Pharmaceutical Analysis: A Guide to Best Practice
-
Practical HPLC Method Development, 2nd Edition
-
Pharmaceutical Dissolution Testing
ASIN: 0471314315 |
Book Description
How to hone your analytical skills and obtain high-quality data in the era of GMP requirements
With increased regulatory pressures on the pharmaceutical industry, there is a growing need for capable analysts who can ensure appropriate scientific practices in laboratories and manufacturing sites worldwide. Based on Johnson & Johnson's acclaimed in-house training program, this practical guide provides guidance for laboratory analysts who must juggle the Food and Drug Administration's good manufacturing practices (GMP) rules with rapidly changing analytical technologies. Highly qualified industry experts walk readers step-by-step through the concepts, techniques, and tools necessary to perform analyses in an FDA-regulated environment, including clear instructions on all major analytical chemical methods-from spectroscopy to chromatography to dissolution. An ideal manual for formal training as well as an excellent self-study guide, Analytical Chemistry in a GMP Environment features:
* The drug development process in the pharmaceutical industry
* Uniform and consistent interpretation of GMP compliance issues
* A review of the role of statistics and basic topics in analytical chemistry
* An emphasis on high-performance liquid chromatographic (HPLC) methods
* Chapters on detectors and quantitative analysis as well as data systems
* Methods for ensuring that instruments meet standard operating procedures (SOP) requirements
* Extensive appendixes for unifying terms, symbols, and procedural information
Customer Reviews:
A "real" practical book.......2004-07-01
This is the book if you work in the analytical lab of pharmaceutical industry. The book covers a lot of practical and day to day problems faced by persons working in the analytical lab especially from a regulatory point of view. Different chapters have been written by area experts making it very useful and comprehensive. I strongly recommend this book.
Books:
- FEMININE MISTAKE, THE: ARE WE GIVING UP TOO MUCH?
- Financial Management: Theory and Practice with Thomson ONE
- Get More Money on Your Next Job: 25 Proven Strategies for Getting More Money, Better Benefits, and Greater Job Security
- Grand Avenues: The Story of the French Visionary Who Designed Washington, D.C.
- History: Fiction or Science? (Chronology, No. 1)
- How To Buy Your First Home, Second Edition
- Indispensable: How To Become The Company That Your Customers Can't Live Without
- Infinite Loop
- Information Technology Control and Audit, Second Edition
- Introduction to Hospitality (4th Edition)
Books Index
Books Home
Recommended Books
- The Elements of Resume Style: Essential Rules and Eye-Opening Advice for Writing Resumes and Cover L
- Getting Things Done: The Art of Stress-Free Productivity
- Weaving Music into Young Minds with Education
- Adam Smith's roles for government and contemporary U.S. government roles: is the welfare state crowd
- Configuring Juniper Networks NetScreen & SSG Firewalls
- Forever a Hustler's Wife: A Novel
- Grammar Practice Activities: A Practical Guide for Teachers
- Stellar Attractions: Pegboard Payroll Simulation
- Air Pollution and Regional Economic Performance: A Case Study
- Animal Invaders of the World: Nature Stories for Children
Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics and Medical Devices
Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation
Drugs-From Discovery to Approval
Research Ethics: A Reader
Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration
