Phase 3b

Phase 3b

The period of time between submission for approval of a new drug and receipt of marketing authorisation.

Phase 3B

A subcategory of a Phase-3 clinical trial, performed near the time of approval to accumulate additional findings which and may be required as a condition of regulatory authority approval. Dossier review may continue while associated Phase-3B trials are conducted.
References in periodicals archive ?
Results from AWARD-10, a Phase 3b, double-blind, parallel-arm, placebo-controlled, 24-week study, show that Indianapolis, Indiana-based global pharmaceuticals specialist Eli Lilly and Company's (NYSE: LLY) Trulicity (dulaglutide) significantly improves A1C (average blood sugar concentration over two to three months) when added to ongoing treatment with a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, the company said.
DUAL VII was a Phase 3b randomised, open-label, multicentre trial that was conducted over the course of 26 weeks in 12 countries and involved 506 patients.
GENEVA -- The interleukin-17A inhibitor ixekizumab provided rapid clearance of genital psoriasis in a phase 3b clinical trial, with significant improvement seen as early as week 1, Caitriona Ryan, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
NYSE: DQ) (NYSE: DQ), a manufacturer of high-purity polysilicon for the global solar PV industry, has received approval from the board of directors for its Phase 3B expansion plan for its polysilicon facilities in Xinjiang.
The Australian Defence Force (ADF) has received its first medium and heavy-duty trucks in Brisbane, with coatings supplied by Axalta Coating Systems, under the Land 121 Phase 3B Defence program.
A phase 3b open-label expanded access program (EAP) provided patients with access to radium-223 prior to regulatory approval and evaluated its safety and efficacy in patients with progressive bone-predominant mCRPC.
Phase 3B is a collection of 48 homes including a range of three-bedroom semi and detached, and four-bedroom houses with prices ranging from PS137,995 to PS210,995.
While they do not find any statistically significant negative effects in Phases 1, 2, and 3A, in Phase 3B they find that trading activity in the affected bonds fell by 41.
Given we had good confidence in the assumptions, we used the same methodology and applied it against Phase 3B operations.
Construction continued on Phase 3B last year, Chevron said, and the project is now expected to be completed in 2016.
The application in the European Union includes data from a Phase 3b open-label, multicenter study, which evaluated the safety and efficacy of Avonex Pen.
Mr Wallace said that work on the final 2,500 sq ft of the scheme, known as phase 3B, would start immediately and was expected to be completed before Christmas.