A Randomized Phase I Study Comparing the Pharmacokinetics of HD201, a Trastuzumab Biosimilar, With European Union-sourced Herceptin.

Purpose: This first-in-human study of HD201 was designed to evaluate the pharmacokinetic (PK) equivalence between this biosimilar candidate and trastuzumab sourced in the European Union (EU-trastuzumab)*.

Methods: In this randomized, blinded, single-dose comparative PK study, healthy male subjects were randomized to receive a single 6 mg/kg IV dose of HD201 or EU-trastuzumab. The primary PK end point was AUC.

Core competencies for pharmaceutical physicians and drug development scientists.

Professional groups, such as IFAPP (International Federation of Pharmaceutical Physicians and Pharmaceutical Medicine), are expected to produce the defined core competencies to orient the discipline and the academic programs for the development of future competent professionals and to advance the profession. On the other hand, PharmaTrain, an Innovative Medicines Initiative project, has become the largest public-private partnership in biomedicine in the European Continent and aims to provide postgraduate courses that are designed to meet the needs of professionals working in medicines development. A working group was formed within IFAPP including representatives from PharmaTrain, academic institutions and national member associations, with special interest and experience on Quality Improvement through education.

Accuracy of a Novel Non-Invasive technology based EZSCAN system for the diagnosis of diabetes mellitus in Chinese.

Background: A new simple technique based on iontophoresis technology (EZSCAN, Impeto Medical, Paris, France) has recently been developed for the screening of diabetes. In the present study, we investigated the accuracy of this system for the diagnosis of diabetes mellitus in Chinese.

Methods: We performed the EZSCAN test in diabetic and non-diabetic subjects.

A new tool to detect kidney disease in Chinese type 2 diabetes patients: comparison of EZSCAN with standard screening methods.

Background: EZSCAN(®) (Impeto Medical, Paris, France), a noninvasive device that assesses sweat gland dysfunction using reverse iontophoresis, also detects early dysglycemia. Given the interrelationships among dysglycemia, vasculopathy, and neuropathy, EZSCAN may detect kidney disease in diabetes (DKD).

Methods: An EZSCAN score (0-100) was calculated using a proprietary algorithm based on the chronoamperometry analysis.

A new non-invasive technology to screen for dysglycaemia including diabetes.

Objective: Assess the ability of a new device based on electrochemical principles using iontophoresis (the EZSCAN) to detect impaired glucose tolerance (IGT) and type 2 diabetes mellitus (DM).

Methods: Eligible Asian Indian subjects, n=212, had anthropometric and blood pressure measurements, followed by an OGTT, HbA1c, serum lipids tests and EZSCAN measurement.

Results: Biochemically, 24 subjects were diagnosed with DM, 30 with IGT, 57 subjects had normal glucose tolerance (NGT) with metabolic syndrome (MS) and 101 had NGT without MS.