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Drug, Medicine, Clinical Trail, Drug Regulator

Roger Nicholas, Ann Roche, Malcolm Dobbin, Nicole Lee
OBJECTIVE: The paper highlights the extent of pharmaceutical drug misuse problems in Australia and explores how pharmaceutical opioid misuse could be reduced by implementation of a technological tool: a prescription co-ordination program (PCP). The paper explores how enhancements to existing computer-assisted clinical decision support systems through real-time, on-line information to prescribers, pharmacists and regulators could address drug-seeking and improve the quality use of medicines...
April 2013: Australian and New Zealand Journal of Public Health
Frederick A Ofosu
The Food and Drug Administration (FDA) approved on July 23, 2010, the abbreviated new drug application (ANDA) by Sandoz Inc for a generic enoxaparin (Lovenox) as the FDA is satisfied with the active ingredient ''sameness'' and the interchangeability of Lovenox with this generic version. Regulatory authorities that consider low-molecular-weight heparins (LMWHs) as drugs approve generic LMWHs via an ANDA pathway, whereas EMEA views them as biological medicines and will therefore regulate copies of LMWHs via a biosimilar pathway because only similar copies can be manufactured...
February 2011: Clinical and Applied Thrombosis/hemostasis
Lila Adnane, Pamela A Trail, Ian Taylor, Scott M Wilhelm
Activating mutations in Ras and B-RAF were identified in several human cancers. In addition, several receptor tyrosine kinases, acting upstream of Ras, were found either mutated or overexpressed in human tumors. Because oncogenic activation of the Ras/RAF pathway may lead to a sustained proliferative signal resulting in tumor growth and progression, inhibition of this pathway represents an attractive approach for cancer drug discovery. A novel class of biaryl urea that inhibits C-RAF kinase was discovered using a combination of medicinal and combinatorial chemistry approaches...
2006: Methods in Enzymology
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