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 ?
14, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced new data from its ongoing Phase 3b TOPAZ-II study evaluating VIEKIRA PAK (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets), with or without ribavirin (RBV), in adult patients with genotype 1a (GT1a) or genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection.
Australia operations of Axalta Coating Systems has signed an agreement with Rheinmetall MAN Military Vehicles Australia (RMMVA) to provide coating products for more than 2,500 Australian military logistic vehicles being produced as part of the Australian government's LAND 121 Phase 3B Defence Project.
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.
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.
We are currently on site with Phase 3b and Phase 4, where we have already sold one unit to accountancy firm RMT, and we begin Phase 5 at the end of February ( a collection of smaller, self-contained offices for the SME market.
Research and development expenses incurred in 1998 primarily consisted of expenses relating to a Phase 3b clinical trial intended to support future marketing activities for Periostat(R), the company's recently approved drug for the treatment of periodontal disease, and expenses for pre-clinical studies for Nephrostat(TM), the company's compound for the treatment of diabetic complications.
Food and Drug Administration (FDA) approved the AVONEX PEN in February 2012 based on data from a Phase 3b study in which approximately nine out of 10 patients used the device successfully.
Phase 3 Is Divided Into 3 Phases: Phase 3a, Phase 3b And Phase 3c.
Presentations will highlight new data from Phase 3b studies of AbbVie's FDA-approved VIEKIRA PAK(TM) (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets), taken with or without ribavirin (RBV), for adults with genotype 1 (GT1) chronic HCV infection, including studies of GT1 patients with chronic kidney disease and genotype 1b (GT1b) patients with compensated cirrhosis.