The European Directorate for the Quality of Medicines & Healthcare announces the publication of a chemometric methods chapter in the European Pharmacopoeia.
The European Directorate for the Quality of Medicines & Healthcare (EDQM) announced on Jan. 25, 2016 the publication of a new chapter in the European Pharmacopoeia Supplement 8.7. “Chemometric methods applied to analytical data” (5.21) introduces the use of chemometric techniques for processing analytical data sets.
The chapter provides good chemometric practice guidelines and requirements and offers a selection of established, most used chemometric methods. Included in chapter 5.21 are an introduction to chemometric methods; good chemometric practice including figures of merit, implementation steps, data considerations, and maintenance; an assessment and validation of chemometric methods; a description of important chemometric techniques; and a glossary.
The agency defines chemometrics, in a press release, “as the chemical discipline that uses mathematical and statistical methods to design optimal measurement procedures and to provide maximum chemical information by analyzing chemical data. It mainly consists of multivariate modeling techniques that result in empirical mathematical models used for the prediction of properties. It helps to structure data sets and to recognize hidden relationships within the system.” EDQM hopes the chapter will encourage the use of chemometric methods for evaluating data generated by near-infrared, Raman, mass, and other spectroscopic methods, as well as data from liquid chromatography–mass spectrometry.
Source:
EDQMRegeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.