By Stefania Spada
Biopharmaceuticals, the time period for genetically engineered healing proteins, monoclonal antibodies, and nucleic acid-based items, became an expanding a part of the pharmaceutical armament. whereas this type of substances money owed for about 25% of all new medicines coming to industry, only a few references exist that evaluate those commercially to be had items. previously, having access to facts at the checklist of at the moment authorized biopharmaceuticals has been arduous and patchy.
Directory of licensed Biopharmaceutical items brings jointly key info on a variety of features of those compounds, featuring a short precis of every biopharmaceutical at present authorized for clinical use. every one precis contains the medical and alternate identify, yr and areas licensed, authorized symptoms, producer, advertising correct, approach to manufacture, medical evaluate, and healing houses. according to details amassed from regulatory businesses and pharmaceutical brands, the ebook offers the main accomplished information at the moment to be had in one, handy volume.
This complete and constant process will retailer pros within the pharmaceutical hours spent trawling the literature - and offers a novel source for destiny reference.
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Additional info for Directory of Approved Biopharmaceutical Products
North. , 24, 579–591, 1998. fm Page 46 Monday, July 19, 2004 8:43 AM Engerix-B Product Name: Engerix-B (trade name) Hepatitis B vaccine (recombinant) (international nonproprietary name) Description: Engerix-B is a vaccine against the hepatitis B virus. It contains the hepatitis B surface antigen (HBsAg) produced by recombinant DNA technology in Saccharomyces cerevisiae. Engerix-B is presented as a suspension in vials or in prefilled syringes for intramuscular administration. ) Therapeutic Indications: Engerix-B is indicated for immunization against hepatitis B.
6, 12–16, 2002. , Rasburicase: a potent uricolytic agent, Expert Opin. , 3, 433–452, 2002. H. , Recombinant urate oxidase for the prophylaxis or treatment of hyperuricemia in patients with leukemia or lymphoma, J. Clin. , 19, 697–704, 2001.
Enzyme replacement therapy in Fabry's disease: a randomized controlled trial, J. Am. Med. , 285, 2743–2749, 2001. ) Rasburicase (international nonproprietary name) Description: Fasturtec or Elitek is a recombinant form of the Aspergillus flavus urate oxidase, the enzyme that converts uric acid to allantoin. It is produced by recombinant DNA technology in yeast cells. The biologically active form of the enzyme is a tetramer, consisting of four identical (34-kDa, 301-amino acid) polypeptides. 5 mg/vial) to be reconstituted and diluted before use as an intravenous infusion.
Directory of Approved Biopharmaceutical Products by Stefania Spada