The partnership agreement covers the lead investigational drug
candidate EB8018 in patients with Crohn's disease, with the potential to expand to other gastrointestinal (GI) disorders and liver diseases.
Our Investigational Drug
Repository offers various storage conditions including ICH stability storage conditions and secure DEA Vault.
Act 345 of 2014), a clear identification of the specific proposed investigational drug
is required in the informed consent document.
In November, Arizona voters will consider a ballot initiative that would likewise give terminally ill patients access to non-FDA-approved investigational drugs
. The Goldwater Institute, a libertarian-leaning nonprofit organization, has drafted model right-to-try legislation and purportedly has met with lawmakers in Florida, Massachusetts, Michigan, Oklahoma, Texas, and Utah who are interested in introducing such bills in their legislatures.
In a 2010 peer-reviewed publication, "NX-1207: a novel investigational drug
for the treatment of benign prostatic hyperplasia" in Expert Opinion on Investigational Drugs
(2010 Feb;19(2):305-10), the author, Neal Shore MD FACS, Medical Director of the Carolina Urologic Research Center, Myrtle Beach, SC, wrote, "Regarding existing oral drug therapies, the use of NX-1207 would obviate daily and lifelong compliance issues as well as the ongoing concerns of polypharmacy facing the elderly and the attendant risk for drug--drug interactions.
The study, a Phase 2 clinical trial, used two doses of the investigational drug
. Its safety already had been tested in healthy volunteers.
(62) According to the court, because the Alliance seeks a right to take drugs with significant risks and no proven therapeutic effect, taking an investigational drug
prior to Phase II trials does not involve the use of reasonable force in self-defense.
In vitro studies are followed by animal studies designed to provide information about toxic effects and the pharmacologic nature and behavior of the investigational drug
. Following successful preclinical research, clinical research may be initiated.
Cardiome said its loss was due to lower licensing and research collaboration fees and increased research and development spending for its lead investigational drug
Kynapid to treat abnormal heart rhythm.
announced on December 15, 2007 that Roche will terminate the License Agreement on Nippon Shinyaku's new investigational drug
, NS-220, for the treatment of dyslipidemia.
Food and Drug Administration has granted priority review status to the company's New Drug Application (NDA) for the investigational drug
The majority's understanding of investigational drug
testing is deficient in several ways.