Product Development Books

Drugs-From Discovery to Approval

Rick Ng

Amazon Price: $66.36 List Price: $82.95 Usually ships in 24 hours By: Wiley-Liss Amazon Marketplace: 39 new & used starting at $29.95

Buy at Amazon.com

Browse similar items by category:
Subjects -> Medicine -> Pharmacology -> General
Subjects -> Medicine -> Pharmacology -> General AAS
Subjects -> Medicine -> General

Customer Reviews:
Total reviews: 8 Average rating: 4.0 of 5

Editorial Review:

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.

Poison Pills: The Untold Story of the Vioxx Drug Scandal

Tom Nesi

Amazon Price: $15.33 List Price: $25.95 Usually ships in 24 hours By: Thomas Dunne Books Amazon Marketplace: 49 new & used starting at $8.51

Buy at Amazon.com

Browse similar items by category:
Subjects -> Medicine -> Administration & Policy -> Public Health
Subjects -> Medicine -> Pharmacology -> General
Subjects -> Medicine -> Pharmacology -> General AAS

Customer Reviews:
Total reviews: 10 Average rating: 3.5 of 5

Editorial Review:

To the millions of Americans who suffer from chronic pain and arthritis, Vioxx seemed like a miracle. One of the most widely promoted and prescribed pain medications in the world -- used by more than twenty million people -- it was endorsed by the medical establishment and celebrities such as Olympic champion figure skater Dorothy Hamill. With annual sales of $2.5 billion, Vioxx became a pharmaceutical bonanza before being abruptly taken off the market in September 2004, after it was revealed that it led to an increased risk of heart-related disease and death.

Drawing on internal documents, video footage, court testimony, and exclusive interviews, as well as three decades of experience inside the medical industry, Tom Nesi tells the dramatic story of what the drug’s manufacturer, Merck, knew and when. It is a compelling narrative of business and medical science run amok, with a cast of characters ranging from those at the highest levels of the multibillion-dollar pharmaceutical industry to research scientists, marketers, and drug company sales reps. Here also are accounts from physicians, lawyers, financial analysts, and patients and their families whose lives have been forever altered by Vioxx.

Set against a fascinating history of the origins of the modern pharmaceutical industry, POISON PILLS is a shocking tale that involves the breakdown of the United States medical system, the failures of the Food and Drug Administration, and enormous profits made by a large pharmaceutical corporation at the potential cost of thousands of lives.

Guide to Drug Development: A Comprehensive Review & Assessment

Bert Spilker

Amazon Price: $159.20 List Price: $199.00 Usually ships in 24 hours By: Lippincott Williams & Wilkins Amazon Marketplace: 28 new & used starting at $153.11

Buy at Amazon.com

Browse similar items by category:
Subjects -> Medicine -> Pharmacology -> Pharmacy
Subjects -> Medicine -> Pharmacology -> General
Subjects -> Medicine -> Pharmacology -> General AAS

Editorial Review:

Written by one of the foremost authorities on clinical trials, drug development, and regulatory affairs, Guide to Drug Development is a comprehensive review of the principles and activities involved in developing new drugs, devices, and other medical products. The book covers many topics not discussed in any other textbook and includes timely discussions on electronic clinical trials, registries of clinical trials, data mining, computer simulations and modeling, and changing regulatory standards. Each chapter includes practical tips, lessons, guides, firsthand stories, quotes from experts, and three to six questions for group discussion. The last three chapters present twelve case studies each on clinical trials, regulatory affairs, and management of drug development. Spilker's Guide to Drug Development will be the standard reference text for everyone working on or studying drug discovery or development, in industry, academia, hospitals, government, and independent laboratories.

Crab Wars: A Tale of Horseshoe Crabs, Bioterrorism, and Human Health

William Sargent

List Price: $24.95 By: UPNE Amazon Marketplace: 15 new & used starting at $1.72

Buy at Amazon.com

Browse similar items by category:
Subjects -> Medicine -> Pharmacology -> General
Subjects -> Medicine -> Pharmacology -> General AAS
Subjects -> Outdoors & Nature -> Ecology -> General AAS

Customer Reviews:
Total reviews: 3 Average rating: 3.0 of 5

Editorial Review:

Surviving almost unmolested for 300 million years, the horseshoe crab is now the object of an intense legal and ethical struggle involving marine biologists, environmentalists, US government officials, biotechnologists, and international corporations. The source of this friction is the discovery 25 years ago that the blood of these ancient creatures serves as the basis for the most reliable test for the deadly and ubiquitous gram-negative bacteria. These bacteria are responsible for life-threatening diseases like menengitis, typhoid, E. coli, Legionnaire's Disease and toxic shock syndrome. Because every drug certified by the FDA must be tested using the horseshoe crab derivative known as Limulus lysate, a multimillion dollar industry has emerged involving the license to "bleed" horseshoe crabs and the rights to their breeding grounds. Since his youthful fascination with these ancient creatures, William Sargent has spent much of his life observing, studying, and collecting horseshoe crabs. As a result, he presents a thoroughly accessible insider's guide to the discovery of the lysate test, the exploitation of the crabs at the hands of multinational pharmaceutical conglomerates, local fishing interests, and the legal and governmental wrangling over the creatures' ultimate fate. In the end, the story of the horseshoe crab is a sobering reflection on the unintended consequences of scientific progress and the danger of self-regulated industries controlling a limited natural resource.

Pharmaceutical Process Validation (Drugs and the Pharmaceutical Sciences)

List Price: $85.00 By: Marcel Dekker Inc Amazon Marketplace: 4 new & used starting at $116.75

Buy at Amazon.com

Browse similar items by category:
Subjects -> Business & Investing -> Economics -> General AAS
Subjects -> Medicine -> Pharmacology -> General
Subjects -> Medicine -> Pharmacology -> General AAS

Customer Reviews:
Total reviews: 1 Average rating: 5.0 of 5

bud loftus shines in his introduction 5 out of 5 stars.
0 of 6 people found this review helpful.

3. Gibbon's Decline and Fall....
2. King James Bible
1. Pharmeceutical Process Validation-Chapter 1

Editorial Review:

The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.

High Throughput Screening: Methods and Protocols (Methods in Molecular Biology) (Methods in Molecular Biology)

Amazon Price: $140.00 List Price: $140.00 In stock soon. Order now to get in line. First come, first served. By: Humana Press Amazon Marketplace: 9 new & used starting at $80.84

Buy at Amazon.com

Browse similar items by category:
Subjects -> Medicine -> Basic Science -> Microbiology
Subjects -> Medicine -> Basic Science -> General
Subjects -> Medicine -> Basic Science -> General AAS

Editorial Review:

In High Throughput Screening, leading scientists and researchers expert in molecular discovery explain the diverse technologies and key techniques used in HTS and demonstrate how they can be applied generically. Writing to create precisely the introductory guidebook they wish had been available when they started in HTS, these expert seasoned authors illuminate the HTS process with richly detailed tutorials on the biological techniques involved, the management of compound libraries, and the automation and engineering approaches needed. Extensive discussions provide readers with all those key elements of pharmacology, molecular biology, enzymology, and biochemistry that will ensure the identification of suitable targets and screens, and detail the technology necessary to mine millions of data points for meaningful knowledge.

Preclinical Development Handbook: ADME and Biopharmaceutical Properties (Pharmaceutical Development Series)

Amazon Price: $156.00 List Price: $195.00 Usually ships in 24 hours By: Wiley-Interscience Amazon Marketplace: 21 new & used starting at $148.20

Buy at Amazon.com

Browse similar items by category:
Subjects -> Medicine -> Pharmacology -> Pharmacy
Subjects -> Medicine -> Pharmacology -> Toxicology
Subjects -> Medicine -> Pharmacology -> General

Editorial Review:

A clear, straightforward resource to guide you through preclinical drug development

Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques.

Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Among the key topics covered are:
*

Modeling and informatics in drug design
*

Bioanalytical chemistry
*

Absorption of drugs after oral administration
*

Transporter interactions in the ADME pathway of drugs
*

Metabolism kinetics
*

Mechanisms and consequences of drug-drug interactions

Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage.

This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.

Miracle Medicines: Seven Lifesaving Drugs and the People Who Created Them

Robert L. Shook

Amazon Price: $20.48 List Price: $26.95 In stock soon. Order now to get in line. First come, first served. By: Portfolio Hardcover Amazon Marketplace: 28 new & used starting at $2.90

Buy at Amazon.com

Browse similar items by category:
Subjects -> Business & Investing -> Management & Leadership -> Management
Subjects -> Medicine -> Pharmacology -> General
Subjects -> Medicine -> Pharmacology -> General AAS

Customer Reviews:
Total reviews: 9 Average rating: 5.0 of 5

Editorial Review:

It’s the business of saving lives.

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 nature
* Lipitor: 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.

Marketing Planning for the Pharmaceutical Industry

John Lidstone, Terry Collier

List Price: $145.00 By: Gower Pub Co Amazon Marketplace: 4 new & used starting at $135.99

Buy at Amazon.com

Browse similar items by category:
Subjects -> Business & Investing -> Economics -> General AAS
Subjects -> Business & Investing -> Management & Leadership -> Management
Subjects -> Business & Investing -> Marketing & Sales -> Marketing -> General

Customer Reviews:
Total reviews: 4 Average rating: 3.5 of 5

It's actually more general than specific to Pharmaceuticals 3 out of 5 stars.
50 of 50 people found this review helpful.

This book is an elegant and agreeable summary of Kotler's marketing management and Porter's competitive strategy. This is half of what I was expecting. However I was also expecting that these broad marketing concepts would be adapted and tailored to the specifics of The Pharmaceutical Industry. Unfortunately and unlike what is suggested by the title, the book has the rhetoric and the feel of a general marketing textbook rather than a Pharmaceutical oriented manual. At a macro level the words "product" or "person-to-person" are far more common than "drug" or "sales representative-to physician". At a micro level the book also favors generalities instead of important Pharmaceutical details. For instance, in the Chapter about Communications (8) the authors extensively discuss the elements of the promotional mix and the relationships with an advertising agency (something important for any industry). However, even in that chapter's section about other considerations, they totally ignore the interaction with regulatory agencies such as the FDA's Division of Drug Marketing, Advertising and Communications. This, as any Product Manager in Pharmaceuticals knows, is crucial for the success of the promotional message. Another similar example can be found in the Chapter about Sales Strategy (7). In here general management consulting matrixes (of the BCG 2X2 type common to any industry) are discussed in detail but the actual industry-specific strategy issues, such as sales force rotation and segmentation of calls to health care professionals, are avoid. Finally I believe that the price of the book ... is meant to be elitist so that is bought only by top management (the potential clients of the authors which are consultants). This is a pity because despite its flaws the books present handy general marketing information in an easy-to-read, friendly format, that emphasizes tables and bullet lists rather than extensive text. It will be useful for non-marketing Pharmaceutical Industry Professionals that interact with Marketing and by Product Managers with no academic business background. For those PM out of business school the book is too basic and contains a relatively small amount of data pertaining to the pharmaceutical industry. Such data can be found elsewhere. For instance the 27 pages of Chapter 2 (marketing Pharmaceuticals) of Schweitzer's book on Pharmaceutical economics and policy contain much more data than this entire Pharmaceutical marketing planning book.

Editorial Review:

The marketing planning system described in the second edition of this book has been designed to enable marketing and product executives in the pharmaceutical industry to produce a plan which serves as a dynamic management tool. A further orientation to external analysis and a reworking of the application of SWOT analysis, along with extra material on sales forecasting and strategy implementation are included.

Patient Number One: A True Story of How One CEO Took on Cancer and Big Business in the Fight of His Life

Rick Murdock, David Fisher

List Price: $24.00 By: Crown Amazon Marketplace: 67 new & used starting at $0.01

Buy at Amazon.com

Browse similar items by category:
Subjects -> Business & Investing -> Business Life -> Ethics
Subjects -> Health, Mind & Body -> Disorders & Diseases -> Cancer -> Lymphatic
Subjects -> Health, Mind & Body -> Disorders & Diseases -> Cancer -> General

Customer Reviews:
Total reviews: 7 Average rating: 4.5 of 5

Editorial Review:

How many victims of cancer have thought, "If only I could order up a cure"?

Rick Murdock could.

In an extraordinary book that proves that truth can be stranger than fiction, Rick Murdock tells the dramatic story of his fight against a deadly lymphoma that could only be treated with technology developed by his own biotech company, and the equally harrowing battle for the survival of his company in a bruising legal dispute with a multibillion-dollar medical products giant.

Rick Murdock was forty-four years old when he was named CEO of CellPro, a thriving biotech company in Seattle that was reaping the benefits of the biotech boom in the late 1980s and early '90s. Wall Street money fueled the flame of cutting-edge research at start-up companies like CellPro, where dedicated scientists were researching treatments that showed great promise in the fight against cancer and other diseases. But then Rick found a lump in his neck, evidence of the acute mantle cell lymphoma raging through his system. This rare form of cancer had no cure: Without a miracle, Rick would die.

At CellPro, Rick found his miracle workers. In a stunning twist of fate, Rick's staff was experimenting with a radical new treatment for advanced lymphomas, though the scientists were months, if not years, away from success. Knowing they were their boss's last hope, these researchers went to work on the experiment that could save Rick's life. If they were successful, Rick would become "patient number one," the guinea pig for a technology that had never been used on humans.
        
The thrilling race against time to save Rick's life is only part of this remarkable story. For while Rick was fighting for his own life, he was also battling a medical products behemoth named Baxter Healthcare and archaic patent laws that threatened CellPro. If CellPro was put out of business, the promising therapies it had been developing for victims of breast cancer, leukemia, lymphoma, and other deadly cancers could disappear. Patient Number One shares the intriguing story of how entrepreneurs and scientists came together to form CellPro, painting a vivid picture of how researchers work tirelessly to come up with new and better treatments for disease, while their financiers play a high-stakes financial game to make money from these medical endeavors. However, in the tradition of books like A Civil Action, Patient Number One is also an illuminating, often scathing look at how medical research is conducted in America today as the bottom line can get in the way of saving lives. Lawyers, politicians, researchers, executives, and investors all want a piece of the biotech pie and will stop at nothing to preserve their special interests, even if it means keeping life-saving treatments from the people who need them.

From tense courtroom scenes between the Goliath-like Baxter and tiny CellPro to anxious moments in the laboratory with Rick's staff and Rick's own agonizing cancer treatments, Patient Number One takes readers into the fascinating, frustrating world of medical research and how it directly affects us all.