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The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth Edition) - Tapa blanda
Sinopsis
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.
"Sinopsis" puede pertenecer a otra edición de este libro.
Críticas
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 School of Law, 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 managers 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
Reseña del editor
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.
"Sobre este título" puede pertenecer a otra edición de este libro.
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The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth Edition)
Publicado por
Brown Walker Press (FL), 2016
ISBN 10: 1627346171
ISBN 13: 9781627346177
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Tapa blanda
Librería: SecondSale, Montgomery, IL, Estados Unidos de America
Calificación del vendedor: 4 de 5 estrellas
Condición: Good. Item in good condition. Textbooks may not include supplemental items i.e. CDs, access codes etc. Nº de ref. del artículo: 00087319933
Cantidad disponible: 1 disponibles
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The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth Edition)
Publicado por
Brown Walker Press (FL), 2016
ISBN 10: 1627346171
ISBN 13: 9781627346177
Antiguo o usado
Tapa blanda
Librería: Bay State Book Company, North Smithfield, RI, Estados Unidos de America
Calificación del vendedor: 5 de 5 estrellas
Condición: good. The book is in good condition with all pages and cover intact, including the dust jacket if originally issued. The spine may show light wear. Pages may contain some notes or highlighting, and there might be a "From the library of" label. Boxed set packaging, shrink wrap, or included media like CDs may be missing. Nº de ref. del artículo: BSM.QH92
Cantidad disponible: 1 disponibles
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The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth Edition)
Publicado por
Brown Walker Press (FL), 2016
ISBN 10: 1627346171
ISBN 13: 9781627346177
Antiguo o usado
Paperback
Librería: ThriftBooks-Atlanta, AUSTELL, GA, Estados Unidos de America
Calificación del vendedor: 5 de 5 estrellas
Paperback. Condición: Very Good. No Jacket. May have limited writing in cover pages. Pages are unmarked. ~ ThriftBooks: Read More, Spend Less 0.95. Nº de ref. del artículo: G1627346171I4N00
Cantidad disponible: 1 disponibles
Imagen de archivo
The Generic Challenge: Understanding Patents, FDA and Pharmaceutical Life-Cycle Management (Fifth Edition)
Publicado por
Brown Walker Press (FL), 2016
ISBN 10: 1627346171
ISBN 13: 9781627346177
Antiguo o usado
paperback
Librería: Studibuch, Stuttgart, Alemania
Calificación del vendedor: 5 de 5 estrellas
paperback. Condición: Gut. 230 Seiten; 9781627346177.3 Gewicht in Gramm: 500. Nº de ref. del artículo: 847924
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