Cardiovascular Toxicity (QT prolongation) in Drug Development Overview
Filed in clinical, pre-clinical, regulatory, March 31, 2009, 5:48 pmQT prolongation, however some people are finding they need a little more information if they are going to tackle and plan for it within their drug development programmes.
Inclusion of Women of Child Bearing Potential- new ICH guidance
Filed in clinical, regulatory, March 30, 2009, 3:28 pmThere has been a major revision of the ICH guidance regarding the use of women of child bearing potential in clinical trials.
Bioequivalence of Therapeutic Proteins
Filed in biotechnology, clinical, regulatory, March 25, 2009, 10:37 amThe EMEA is the only regulator to introduce regulations, these regulations make it clear that biosimilars are not the same and are not regulated in the same was as generic drugs
New Microdosing / Expolaratory drug studies – Phase I clinical Trials.
Filed in clinical, regulatory, March 19, 2009, 3:49 pmOne of my Colleagues Dr Anthony Lockett recently attended a presentation by David R. Jones an expert scientific assessor (Pharmacotoxicologist) at the MHRA who gave a very useful update on the area of safety testing with regard to Phase I studies.
One of the topics under discussion was Microdosing in Phase 1 clinical trials.
There is a [...]
Clinical Trials in Eastern Europe
Filed in clinical, regulatory, March 12, 2009, 12:14 pmThere has been allot of talk about running clinical trials in Eastern Europe, but what are the statistics and the feasibility, I have been looking at this and have some information to share.I have had a quick look at the following areas:
Hungary
Poland
Czech Republic
Slovenia
Slovakia
and some Baltic states
All the above appear to be great with clear and [...]
Access to Finance – New Yorkshire Forward Initative
Filed in Fund raising, licensing, March 4, 2009, 4:42 pmJust a breif note on a new Yorkshire Forward initiative, Access to Finance for Healthcare.
It is a programme designed to assist healthcare technology companies prepare for and go out on fund raising programmes, right up to being introduced to investors.
The programme is being run by Grant Thornton in Leeds and is on the back of [...]
