Beclometasone Dipropionate/Formoterol Fumarate is Similarly Effective to Budesonide/Formoterol Fumarate in Chinese Patients with COPD: The FORSYYN Double-Blind, Randomised Study.

Unlabelled: The fixed-dose combination of beclometasone dipropionate/formoterol fumarate (BDP/FF) delivered pressurised metered-dose inhaler (pMDI) has demonstrated efficacy in chronic obstructive pulmonary disease (COPD), in studies predominantly conducted in Caucasian adults. The current study evaluated the efficacy and safety of BDP/FF pMDI in Chinese patients with COPD, as part of registration for COPD in China. This double-blind, double-dummy, randomised, parallel-group study was conducted in patients with COPD of Chinese ethnicity aged ≥40 years.

Tolerance and Safety of an Anti-Regurgitation Formula Containing Locust Bean Gum, Pre-, and Postbiotics: A Multi-Country Multi-Center Prospective Randomized Controlled Study in Infants with Regurgitation.

This multi-center prospective randomized controlled trial was a tolerance and safety study investigating the thickener locust bean gum (LBG) in infants with regurgitation, to support the re-evaluation of the safety of LBG in infant formula. The primary objective was to demonstrate that after an 8-week intervention, stool consistency was not inferior (i.e.

An Overview of Current Statistical Methods for Implementing Quality Tolerance Limits.

Background: In 2016, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use updated its efficacy guideline for good clinical practice and introduced predefined quality tolerance limits (QTLs) as a quality control in clinical trials. QTLs are complementary to Quality by Design (QbD) principles (ICH-E8) and are one of the components of the risk-based clinical trial quality management system.

Methods: Currently the framework for QTLs process is well established, extensively describing the operational aspects of Defining, Monitoring and Reporting, but a single source of commonly used methods to establish QTLs and secondary limits is lacking.

The composite dataset of the present-day Infralittoral Prograding Wedges (IPWs) in the inner continental shelf of the Campania region (Central-Eastern Tyrrhenian Sea).

This article reports on the dataset gathered following the census of 83 present-day Infralittoral Prograding Wedges (IPWs), surveyed on the inner continental shelf of the Central-Eastern Tyrrhenian Sea. The purpose of the census was to explore their bathymetric range and assess the observational laws governing this variability. The ensued dataset (Campania Region IPW Dataset, CRID) includes geographic, topographic and morpho-bathymetric indices, descriptive of each IPW and more, the exposure of each IPW to wave forcing (Geographical fetch, Effective fetch and extreme significant wave height, H ).