RESUMO
The use of quality control (QC) samples in bioanalysis is well established and consistent with regulatory guidance. However, a systematic evaluation of whether QC samples serve the intended purpose of improving data quality has not been undertaken. The Translational and ADME Sciences Leadership Group (TALG) of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) conducted an evaluation to assess whether closer agreement is observed when comparing pharmacokinetic data from two passed runs, than when comparing data from failed and passed (retest) runs. Analysis of data collected across organizations, molecular types and analytical platforms, revealed that bioanalytical methods are very reproducible; and that QC samples improve the overall quality of pharmacokinetic concentration data and justifies their continued use.
Assuntos
Técnicas Biossensoriais/métodos , Preparações Farmacêuticas/química , Humanos , Controle de QualidadeRESUMO
There are many ocular diseases still presenting unmet medical needs. Therefore, new ophthalmologic drugs are being developed. Bioanalysis of eye compartments (along with plasma and other tissues) is important to determine exposure of the target organ to the drug and to help interpret local pharmacological or toxic effects. This review article identifies several challenges that occur within ocular bioanalysis. They include sample collection and preparation, analytical issues, sourcing control matrix, data interpretation and regulatory requirements. It summarizes how these challenges have been recently addressed, how research has advanced and which questions remain unanswered. Recommendations are made based on the literature and our practical experience within ocular bioanalysis and future perspectives are discussed.