Safety program builds savings for contractor. (Baker Concrete Construction...

Business Insurance;  December 12, 1994 ;     370 words ......SHM) Thursday filed its response to clinical hold issues raised by the U.S. Food and...original IND was filed on Aug. 19. A clinical hold was placed on the application 30 days...company's application that details the clinical hold issues, said Kellman. Because of the...

Regional cerebral blood flow response to oral amphetamine challenge in...

The Journal of Nuclear Medicine;  April 1, 2001 ;     700+ words ......flow (rCBF) measured by SPECT in healthy volunteers to characterize the normal CNS response...rCBF induced by amphetamine in 16 healthy volunteers. Subjects received placebo and then...triple-head tomograph. Another six healthy volunteers received placebo at both times to...

Lift ED drug's clinical hold, Zonagen asks.(Brief Article)

Medical Marketing & Media;  June 1, 2000 ;     79 words ...* Hoping to have a clinical hold on development of its Vasomax and Vasofem lifted, Zonagen says...disorder. The Food and Drug Administration placed the programs on clinical hold last August because preliminary findings from the rat study...

Phase 1: Clinical development

Biopharm;  March 1, 2002 ;     700+ words ......000 Scale: grams of product (20-80 healthy volunteers) Success Rate: 15% A small-scale...About 20-80 subjects are involved (healthy volunteers or patients who are in relatively...poorly tolerated. Phase 1 studies use healthy volunteers who are paid for exposing themselves...

FDA Maintains Clinical Hold on Alteon's ED Study of Alagebrium.

PR Newswire;  September 30, 2005 ;     700+ words ......Division that it is maintaining the clinical hold previously placed on the Company's...and Urologic Drug Products placed on clinical hold further enrollment in the EMERALD study...data, it has decided to maintain the clinical hold pending further preclinical testing...

Telik Announces Clinical Hold on TELCYTA Trials.

PR Newswire;  June 5, 2007 ;     598 words ......Drug Administration (FDA) has placed a clinical hold on the Investigational New Drug (IND...TELCYTA(R) (canfosfamide HCl). The clinical hold was initiated by FDA following the...treatment until the FDA releases the clinical hold. Telik plans to submit to the FDA additional...

Inhalation scintigraphy with iodine-123-labeled interferon gamma-1b:...

The Journal of Nuclear Medicine;  September 1, 1997 ;     700+ words ......biodistribution and radiation absorbed doses in healthy volunteers. Methods: IFNg was labeled with...various functional in vitro tests. Ten healthy volunteers were enrolled in the in vivo dose...and shows no systemic effects in healthy volunteers. Key Words: iodine-123-IFNg; ...

Insulin Resistance and Adiponectin Levels in Drug-Free Patients With...

Canadian Journal of Psychiatry;  May 1, 2006 ;     700+ words ......schizoaffective disorder with that of matched healthy volunteers. Method: We evaluated 9 nondiabetic...patients was 42% lower than that of the healthy volunteers (P = 0.026), with inadequate compensation...patients with schizophrenia and matched healthy volunteers. Methods We studied ...

AVAX Provides Regulatory Update.

PR Newswire;  April 23, 2001 ;     700+ words ......confirming the previously-reported clinical hold of AVAX's M-Vax and O-Vax autologous...prepare a comprehensive response to the clinical hold inquiries received from the FDA. Given...from the Company. Accordingly, the clinical hold cannot presently be characterized as...

SPECT of Serotonin Transporters Using ^sup 123^I-ADAM: Optimal Imaging...

The Journal of Nuclear Medicine;  August 1, 2005 ;     700+ words ......to characterize ^sup 123^I-ADAM in healthy volunteers. ^sup 123^I-ADAM distribution in...reliability were investigated. Methods: Ten healthy volunteers underwent 2 SPECT sessions under...dosimetry data of ^sup 123^I-ADAM in healthy volunteers support its use in humans (4,5...

Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics...

PR Newswire;  November 1, 2008 ;     700+ words ......Phase I clinical trial of ANA598 in healthy volunteers and additional preclinical data that...Study Results In the Phase I study in healthy volunteers, ANA598 was administered as capsules...Non-Nucleoside NS5B Polymerase Inhibitor, in Healthy Volunteers , at 1:00 p.m. PST on Monday, ...

Ribozyme Pharmaceuticals Initiates Angiozyme(TM) Trial in Healthy...

PR Newswire;  November 4, 1998 ;     700+ words ......initiate a Phase I clinical trial in healthy volunteers. The Investigational New Drug (IND...single doses of ANGIOZYME(TM) in healthy volunteers. It will also define the pharmacokinetics...us to conduct our initial trial in healthy volunteers, which is quite unusual for an ...

FDA Maintains Clinical Hold on VaxGen's Anthrax Vaccine Trial.

PR Newswire;  December 18, 2006 ;     555 words ......company that it is maintaining its clinical hold on the company's second Phase II trial...formulation development. However, the clinical hold will remain in place until sufficient...over vaccine stability, to resolve the clinical hold imposed by FDA/CBER and to perform...

ViaCell Announces Clinical Hold Formalizing Suspension of Enrollment in...

PR Newswire;  September 21, 2005 ;     622 words ...-- Clinical Hold Not in Response to New Events...Administration (FDA) has placed a clinical hold on the Company's Phase I clinical...affected by a variety of cancers. The clinical hold is not in response to any new events...

Characterization of the SPECT 5-HT^sub 2A^ Receptor Ligand ^sup...

The Journal of Nuclear Medicine;  June 1, 2006 ;     700+ words ......ketanserin challenges were performed on healthy volunteers with the aim of assessing the specificity...quantification methods have been reported in healthy volunteers for subtype 2A of the 5-hydroxytryptamine...effect on cerebellar uptake in 3 healthy volunteers at a ketanserin dose ...