MLM Medical Labs Logo Fax Symbol Envelope Symbol Phone Symbol Search Symbol Account Symbol Done Symbol Close Symbol Arrows pointing left and right symbol Calendar symbol Calendar checked symbol Book symbol Phone symbol Desktop symbol Unit conversion Symbol User symbol Arrow top symbol Arrow right symbol Arrow bottom symbol Arrow left symbol Sample analysis Symbol Method development Symbol Data management Symbol Study preparation Symbol Sample storage Symbol Logistics Symbol Availability Symbol Address Symbol Clients Symbol Corporate Profile Symbol Feedback Symbol Customer Request Form Symbol Customised Solutions symbol Compliance Symbol Careers Symbol Community Symbol News Archive Symbol News Symbol Publications Symbol Quality Symbol Scientific Excellence symbol Management Team Symbol Web-Access Symbol 365-day service Symbol Personal Accountability Symbol Twitter symbol LinkedIn symbol Kit Building Symbol Safe Guard Box Symbol Archiving Symbol MLM in Motion Partner Assay Development Assay Development Blau Biomarker Services Biomarker Services Blau Histology Histology Blau Implantable Device Implantable Device Blau Preclinical Preclinical Blau Newsletter Genetik

Compliance

Essential and relevant international guidelines

Method Validation

Guidelines from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are applied in the validation of bioanalytical methods for pharmacokinetic and bioequivalence studies as well as many pharmacodynamic parameters. They define the requirements with respect to response function, precision, accuracy and stability. As an organization following Good Clinical Laboratory Pratice, we follow these guidelines in our validation studies for bioanalytical methods.

The most recent versions of these guidelines can be downloaded here.

EMA Reflection Paper for Laboratories involved in Clinical Studies

The European Medicines Agency (EMA) has issued a reflection paper for laboratories that contribute to clinical studies. It details tighter requirements for the conduct of laboratory analyses for clinical studies and for the quality systems of the laboratories involved. Interestingly, standard clinical chemistry and hematology are also subject to these requirements to the same extent as sophisticated biomarker assays.

The reflection paper can be downloaded here.