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 class of substances debts for about 25% of all new medications coming to marketplace, only a few references exist that overview those commercially on hand items. beforehand, having access to information at the checklist of presently licensed biopharmaceuticals has been exhausting and patchy.
Directory of authorized Biopharmaceutical items brings jointly key details on a variety of features of those compounds, proposing a short precis of every biopharmaceutical at present authorized for clinical use. every one precis comprises the clinical and alternate identify, 12 months and areas authorized, licensed symptoms, producer, advertising correct, approach to manufacture, clinical review, and healing houses. in response to details accrued from regulatory organizations and pharmaceutical brands, the e-book offers the main finished info at present on hand in one, handy volume.
This complete and constant procedure will keep pros within the pharmaceutical hours spent trawling the literature - and gives a unique source for destiny reference.
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Additional info for Directory of Approved Biopharmaceutical Products
Fabrazyme should not be administered with chloroquine, amiodarone, benoquin, or gentamicin. No safety and efficacy studies were carried out on patients under 16 or over 65 years old. Fabrazyme is contraindicated during pregnancy and lactation. M. , A phase 1/2 clinical trial of enzyme replacement in Fabry's disease: pharmacokinetic, substrate clearance, and safety studies, Am. J. Hum. , 68, 711–722, 2001. M. , Safety and efficacy of recombinant human alpha-galactosidase A — replacement therapy in Fabry's disease, N.
Chem. News, 64(1681), 19, 1995. Zadik, Z. , Effect of timing of growth hormone administration on plasma growth hormone binding activity, insulin like growth factor-1 and growth in children with a subonormal spontaneous secretion of growth hormone, Horm. , 39(56), 188–191, 1993. fm Page 31 Monday, July 19, 2004 8:43 AM Bioclate Product Name: Bioclate (trade name) Antihemophilic factor (recombinant) (international nonproprietary name) Description: Bioclate consists of a recombinant human coagulation factor VIII, the recombinant antihemophilic factor (rAHF).
Routine evaluative tests are carried out on the final product to ensure its quality and safety. Overview of Therapeutic Properties Multiple sclerosis (MS) is a chronic, disabling disease of the central nervous system. In the benign form (15% of cases) no disabilities occur, whereas primary progressive MS (10 to 15% of cases) brings minor loss of function. The majority of patients (70%) suffer from relapsing-remitting and secondary progressive disease and develop significant disabilities — either gradually or due to the relapsing-remitting, which involves a worsening of the disease followed by partial or complete recovery.