NEWSLETTER SUMMER 2017
In September we’ll say goodbye to the summer, but we have the perfect solution to admire color of the autumn in the park : come celebrate with us !
SAY HELLO TO ENOVAL V4.0 !
Arlenda is delighted to announce the release of Enoval V4.0, a software dedicated to the validation of analytical methods. Enoval allows you to generate an e-CTD compliant validation report within minutes, in full compliance with authority expectations (ICH, FDA and ISO)! This major release features a new Graphical User Interface as well as an incredible number of improvements. Extensive work has been carried out on the upgrading of the internal components of the software in order to ensure its future and fulfil your needs. Don’t waste your employee’s time and stay in the competition by using Enoval 4.0 ! Arlenda
ARLENDA AND BIOSIMILARS
Arlenda scientists are actively contributing to propose relevant and practical solutions to assess the analytical similarity of biologicals. Challenges are considerable from a statistical point of view. With several partners Arlenda is exploring and proposing solutions that are fit-for-purpose. These will be presented at next ASA-FDA Biopharmaceutical Section Regulatory-Industry Statistics Workshop in September (amstat meeting) and 4th Statistical and Data Management Approaches for Biotechnology Drug Development in November (IABS).
EMA DRAFT : WE WANT YOU TO COMMENT !
The EMA published the Draft reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development providing current regulatory considerations regarding statistical aspects for the comparative assessment of quality attributes in the settings of pre- and post-manufacturing change, biosimilar development as well as generics development. Bruno Boulanger (Bruno.Boulanger@arlenda.com) is collating comments on behalf of EFSPI, so please send any comments you have on the reflection paper to Bruno by February 28 2018.
A WORLD BEYOND P<0.05 !
Arlenda is already providing statistical methods for the 21st century. This is at the heart of Arlenda credo and action since its birth: advising companies to make appropriate decisions based on the valuable data they generated, mostly using Bayesian statistics. Arlenda repeatedly mentioned the risk of using blindly p-values particularly in the research and development activities. The major concerns raised by the misuse of p-values is now getting to the next stage with ASA and FDA with the conference on Statistical Inference (amstat meeting). Don’t miss this conference and meet Arlenda scientists.
LET’S MEET AND CHAT