Ebook The Generic Challenge Understanding Patents FDA and Pharmaceutical LifeCycle Management Fifth Edition 9781627346177 Medicine Health Science Books
Download As PDF : The Generic Challenge Understanding Patents FDA and Pharmaceutical LifeCycle Management Fifth Edition 9781627346177 Medicine Health Science Books
This Fifth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.
Ebook The Generic Challenge Understanding Patents FDA and Pharmaceutical LifeCycle Management Fifth Edition 9781627346177 Medicine Health Science Books
"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."
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Tags : The Generic Challenge Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth Edition) 9781627346177 Medicine Health Science Books @ ,Martin A Voet,The Generic Challenge Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth Edition),Brown Walker Press,1627346171,FDA,LAW / Intellectual Property / Patent,LAW / Medical Law Legislation,Law/Medical Law Legislation,MEDICAL / Pharmacology,Medical/Pharmacology,generic drugs,pharmaceutical law,pharmaceutical law; generic drugs; FDA; Hatch Waxman Act; patent law
The Generic Challenge Understanding Patents FDA and Pharmaceutical LifeCycle Management Fifth Edition 9781627346177 Medicine Health Science Books Reviews :
The Generic Challenge Understanding Patents FDA and Pharmaceutical LifeCycle Management Fifth Edition 9781627346177 Medicine Health Science Books Reviews
- 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. - I just started working for a generic pharmaceutical company. I came from working in the FDA. I thought this book provided an excellent overview into patent law and the need for refudling the generic pipeline. I learned a lot in the first read-through and expect to continue to learn from it as a reference. I recommend it.
- This is a condensed text regarding to what should we know about patents in the pharmaceutical business
- 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.
- Not a bad read considering the subject. The author inserts some funny statements I did not expect in this sort of book.
- I agree completely with B. Vendsel's review. The horrible formatting in the edition is very distracting.
This might be an excellent book but I can only wade through a few screens before having to set it aside out of sheer aggravation.
I hope the publishers would see fit to re-format this book and give those of us who purchased it a copy that is actually readable. - Good condition
- Condiciones perfecto. Detemir - brand name levemir - is a long-acting insulin preparation for injection. It has a 14 carbon fatty acid chain added at B-29 amino acid position that when given subcutaneously induces binding to albumin. This binding to albumin, and Levemir's tendency to form hexamer self-associations prolong absorption time. Type I diabetics, self-administering 0.2units/kg of insulin per day can simulate a basal insulin level for 14-16h after just one injection. However, those requiring 0.3units/kg of detemir can simulate a basal insulin level lasting up to 24h after just one injection. This latest dosage regimen may be most beneficial for type-II diabetics, as they typically require more units of insulin per day to reach normal glycemic blood levels, and thus would only require one self-administration of detemir daily. Back to the topic at hand... This book was recommended to me by Jeff Hayes Ph.D. who is the Intellectual Property Manager for Materials Science and Technology at P&G Cincinnati, OH. A fantastic book. Enjoyed every minute. Definitely something to keep on the bookshelves.
