MARC Record from Library of Congress

LEADER: 01904cam a22002898a 4500
001 2012015100
003 DLC
005 20131030075259.0
008 120412s2013 vau b 001 0 eng
010 $a 2012015100
020 $a9781617460081 (alk. paper)
040 $aDLC$cDLC$dDLC
043 $an-us---
050 00 $aKF3133.D78$bB56 2013
082 00 $a346.7304/86$223
245 00 $aBiologic patent law and regulation /$cWilliam J. Simmons, editor-in-chief.
260 $aArlington, VA :$bBloomberg BNA,$cc2013.
263 $a1412
300 $ap. cm.
504 $aIncludes bibliographical references and index.
505 0 $aIssues and perspectives on patenting of biologics -- Biologic patent law in the U.S. -- Biologic patenting beyond the U.S. -- Philosophy of patenting of biologics -- Economics of patenting of biologics -- The origins of regulation of biologics as drugs -- Understanding how biologics are regulated in the U.S. --Regulatory authority and organizations in the U.S. -- Types of biologics and associated regulatory approaches : human cells, tissues, and cellular and tissue-based products -- Blood and blood components -- General requirements for biologic products : vaccines, viruses, and spores -- Drugs -- Gene therapy and cellular therapy -- WJS February 28, 2012 -- Human organs for transplantation -- Xenotransplantation -- Combination products -- Stem cells -- Emerging issues in biologic regulation -- Fundamentals of biologic discovery and production and issues in making and using biosimilar biologics -- Small molecules, energy, and biosynthesis -- Macromolecules -- Protein function -- Basic genetic mechanisms.
650 0 $aDrugs$zUnited States$vPatents.
650 0 $aPatent laws and legislation$zUnited States.
650 0 $aBiotechnology$zUnited States$vPatents.
650 0 $aDrugs$vPatents.
650 0 $aBiotechnology$vPatents.
700 1 $aSimmons, William J.