Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
|Articles|May 26, 2011
PharmaNet and Maisonneuve-Rosemont Hospital Collaborate to Evaluate Innovative Drugs
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At PharmaNet's clinical pharmacology unit in Canada, new drugs are evaluated in Phase I clinical studies for PharmaNet's clients. Under the current FDA draft guidance, certain of these studies require the evaluation of drug products in study participants that have impaired renal function. The collaboration with HMR will provide PharmaNet enhanced access to potential study participants with mild, moderate, or severe impaired renal function.
"We are very pleased to partner with HMR," commented Riaz Bandali, President, Early Stage Development. "Demand for the conduct of pharmacokinetic studies in patients with impaired renal function is increasing. By partnering with HMR we can efficiently conduct trials in patients with various levels of renal impairment, while assuring the patients' safety and well-being."
Mr. Bandali added, "We view this partnership with HMR as an important first step in PharmaNet's strategy to expand our academic expertise and the number of first-in-person and patient studies that we conduct in hospital settings."
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