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The Generic Challenge is a must-read for pharmaceutical executives and managers, and regulatory, legal, business development, R&D and strategic marketing professionals and anyone who has an interest in the future of the leading American pharmaceutical and biotechnology industries and the high value jobs they provide. It explains clearly and understandably the role of patents, FDA regulation of generic drugs and the Hatch Waxman Act on drug development today and how improvements in innovative drug products provide enhanced benefits to patients while extending the commercial lives of the drugs.There is simply no other book of its kind available on this important subject. REVIEWS "I read The Generic Challenge in one evening. It is easy to read, anecdotal and short. It is hard to believe that so much information and seasoned advice is packed into this little book. Patents and FDA Exclusivity form the bedrock foundation of today's pharmaceutical and biotechnology industries. I would recommend this book to virtually everyone working in those industries -- from the CEO down to the drug reps and lab techs -- regardless of whether they will deal directly with patents." -Dennis Crouch, Associate Professor of Law, University of Missouri, Editor of Patently-O.com "An extraordinary book full of practical, strategic information on the interaction of drug creation, law and regulatory approval. Provides a perceptive and insightful analysis of patent and regulatory laws affecting drug development. A must-read for anyone associated with a pharmaceutical company, from mangers and CEOs to CFOs and regulatory professionals, The Generic Challenge will guide readers through the many legal and business pitfalls that arise at every stage of their business." -Stephen R. Albainy-Jenei, Attorney at Law, Editor of PatentBaristas.com

• Sales Rank: #1775358 in Books
• Published on: 2011-03-05
• Original language: English
• Number of items: 1
• Dimensions: 8.50" h x .42" w x 5.51" l, .52 pounds
• Binding: Paperback
• 198 pages

Most helpful customer reviews

9 of 10 people found the following review helpful.
Accessible Primer on Patents & Exclusivity in the Pharma Industry
By Jeffrey S
As a consultant in the pharmaceutical/biotech industry, I found this reading to be pleasantly illuminating and gently absorbing (took only 2 leisurely days to read). Although having some exposure to law school pedagogy and lingo myself, Mr. Voet explains the legal underpinnings of patent law with a simplistic and logical exposition interlaced with sufficient detail, precision and nuance (as is expected in any effective discussion on law). He begins his tour from the basic definition of a patent, and guides the reader through important matters like patent claims, interference, "doctrine of equivalents", and some noteworthy legal precedents that guide current interpretations of patent law (for example, how the Merck v. Integra decision provides "safe harbor exemption" for infringements that pertain to preclinical and clinical research pursuant to FDA submission). Not lost in Voet's description is the distinctive legal environments and dynamics in other key pharmaceutical markets like the E.U., Canada and Japan, and those variations are aptly examined. While there is indeed a distinction between patent rights and market exclusivities, Voet describes the interplay between the two in the ever critical task of product life-cycle management. His own pharma industry experience enriches his exposition by revealing industry-specific patterns (like the propensity for innovator companies to file broad drug compound patents and padding with narrow patents on formulation, new indications, etc.), and walking through illustrative examples and case studies (like Syntex's life-cycle strategy on Acular 0.5% against generic threats by the notorious Apotex). Despite the admittedly dynamic nature of patent law and market exclusivities, Voet's material is refreshingly up-to-date (referring to events/considerations as recent as 2007-08). Key takeaways are neatly summed up at the end of each chapter, and an exhaustive glossary is available to keep the reader reminded of key terminology. Overall, an easy and necessary read for anyone wanting to delve in the complex arena of pharmaceutical product life-cycle management.

2 of 2 people found the following review helpful.
Good and comprehensive overview
By Greg
This is a fairly well written overview of generic gaming. While intellectual property and regulatory affairs are central themes of this industry, the author keeps the reader interested with relevant illustrations and a light writting style. All aspects of pIVs, litigations, and LCM are covered in a way that is accessible to the neophyte while preserving details and nuances for the pharma professional. As far as I remember, this was the only book available on the topic that I was able to find. However I would recommend it for both its content and conciseness.
Good for students/policy makers researching the topic, portfolio managers at innovator pharmas, job seekers in the generic industry, and the general audience.

4 of 4 people found the following review helpful.
For all pharma managers
By Anita
Best book on understanding patents for business managers. Good for generics and branded alike. But it's heavy on the patent piece so grab a big mug o' joe because you will nod off a few times.

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Espressif’s ESP8266 is among the most integrated WiFi chips in the industry; it integrates the antenna switches, RF balun, power amplifier, low noise receive amplifier, filters, power management modules, it requires minimal external circuitry, and the entire solution, including front-end module, is designed to occupy minimal PCB area.
The ESP8266 also integrates an enhanced version of Tensilica’s L106 Diamond series 32-bit processor, with on-chip SRAM, besides the Wi-Fi functionalities.
The ESP8266 is the base for several ESP modules some of them will be introduced here.
The ESP8266 is RoHS-conform and has all required certificates, as FCC & CE. Therefore, no restrictions for its use in applications will be expected.
NodeMCU is an open source IoT platform. It uses the Lua scripting language. It is based on the eLua project, and built on the ESP8266 SDK 0.9.5. It includes firmware which runs on the ESP8266 and hardware which is based on the ESP-12 module.
A few lines of Lua are sufficant to build a web server or client, a MQTT publisher or subcriber or connecting peripherals. This kind of applications are in focus here.

• Sales Rank: #99166 in eBooks
• Published on: 2015-11-24
• Released on: 2015-11-24
• Format: Kindle eBook

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5 of 5 people found the following review helpful.
The perfect book for getting started with ESP8266, nodemcu, and lua
By dudefromFL
I've been very curious about the ESP8266, and I started looking at it over Thanksgiving week. I scoured the internet for information on getting started, but the content is all over the place in bits and pieces and in some cases out-of-date. I took a gamble on this book, and it was exactly what I needed to get started with EsP8266, nodemcu, and lua with a minimal amount of fuss. The explanations were thorough enough, and the example code helps you be productive faster. If you are getting started with ESP8266, I would strongly recommend this book.

3 of 3 people found the following review helpful.
Perfect introduction to ESP8266 and NodeMCU
By my2cents
Please find my complete review at [...]

“Building an IoT Node for less than 15 $” is the book I wish I had had when I started my endeavor into the IoT/ESP8266/NodeMCU world in May 2015. I covers everything you need to know to get you started even if you don’t have a any prior experience in electronics or low-level programming (firmware, C/C++ etc.). It teaches you a bit about the chip and modules equipped with it, gives you a Lua primer and contains lots of helpful examples.

0 of 0 people found the following review helpful.
Five Stars
By ryan
I found it informative and it helped with my project.

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[U911.Ebook] Free Ebook Pesticide Application Methods, by Graham Matthews

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Detailed information is provided on the role of chemical control in crop protection: targets, formulations and droplets, spray quality and the choice of nozzles are discussed, as are improvements in the design of new equipment, safety precautions and maintenance issues. Two new chapters highlight the application of biological pesticides and equipment used in the evaluation of pesticides.

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• Sales Rank: #4755240 in Books
• Brand: Brand: Wiley-Blackwell
• Published on: 2000-12-19
• Original language: English
• Number of items: 1
• Dimensions: 9.40" h x 1.10" w x 6.40" l, 2.12 pounds
• Binding: Hardcover
• 452 pages

Features

• Used Book in Good Condition

Review
Aslib Book Guide, Nov 2001:
"Of major value to those involved in crop protection in all parts of the world, as an overview and to assist in training in the safe and efficient use of agrochemicals."

From the Back Cover
Pesticide Application Methods is the standard work for all those involved in crop protection. This fully revised edition provides up-to-date information on the different types of application techniques and how they should be used to ensure efficient and effective pest control.

Detailed information is provided on the role of chemical control to crop protection: targets, formulations and droplets, spray quality and the choice of nozzles are discussed, as are improvements in the design of new equipment, safety precautions and maintenance issues. Two new chapters highlight the application of biological pesticides and equipment used in the evaluation of pesticides.

This important new edition is a commercially important reference tool and will be of great use and interest to all those working in crop protection, including agricultural entomologists and plant pathologists, pesticide scientists, advisors and consultants, large-scale growers, agricultural and horticultural scientists, agrochemical industry personnel including those involved in equipment supply and product formulation. Libraries in government and commercial research establishments, universities and agricultural colleges and anywhere the subject is taught or studied should have multiple copies of this definitive book on their shelves.

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The gold-standard of pharmacology texts – updated to reflect the latest developments and breakthroughs

Goodman & Gilman’s: The Pharmacological Basis of Therapeutics, Thirteenth Edition represents the pinnacle of authority and accuracy in describing the actions and uses of therapeutic agents in relation to physiology and pathophysiology. Goodman & Gilman’s careful balance of basic science and clinical application has guided thousands of practitioners and students to a clear understanding of the drugs essential to preventing, diagnosing, and treating disease.

Enhanced by a full-color presentation and updated to reflect all critical new developments in drug action and drug-disease interaction, the Thirteenth Edition includes more than 440 color illustrations depicting key principles and actions of specific pathways and therapeutic agents. This edition also includes new chapters on hypertension therapy, myocardial ischemia therapy, treatment of pulmonary arterial hypertension, immunostimulants and vaccines, and treatment of viral hepatitis, along with appendices on prescription order writing, patient compliance, and pharmacokinetics

Goodman & Gilman’s The Pharmacological Basis of Therapeutics, Thirteenth Edition is divided into nine sections, covering:

•�General Principles
•�Neuropharmacology
•�Modulation of Pulmonary, Renal, and Cardiovascular Function
•�Inflammation, Immunomodulation, and Hematopoiesis
•�Endocrine Pharmacology
•�Gastrointestinal Pharmacology
•�Chemotherapy of Infectious Disease
•�Chemotherapy of Neoplastic Diseases
•�Special Systems Pharmacology

�

• Sales Rank: #123798 in Books
• Published on: 2017-10-26
• Original language: English
• Binding: Hardcover
• 1808 pages

About the Author

Laurence L. Brunton, PhD is Professor of Pharmacology and Medicine, University of California-San Diego School of Medicine.
Bjorn C. Knollmann, MD, PhD is Professor of Medicine and Pharmacology, Vanderbilt University School of Medicine.
Randa Hilal-Dandan, PhD is Lecturer in Pharmacology, University of California-San Diego School of Medicine.

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• Sales Rank: #1115869 in Books
• Published on: 2012-01-01
• Original language: English
• Number of items: 1
• Dimensions: 11.22" h x .71" w x 8.98" l, 3.17 pounds
• Binding: Paperback
• 288 pages

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• Sales Rank: #1908272 in Books
• Published on: 2006-09-01
• Released on: 2006-09-01
• Original language: English
• Number of items: 1
• Dimensions: 6.78" h x 1.08" w x 4.22" l,
• Binding: Mass Market Paperback
• 384 pages

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