A narrative for bioanalytical method development

Bioanalytical Method Development Strategy for Therapeutic Peptides

High-throughput method development approaches for bioanalytical mass spectrometry.

A rational approach to the development and optimization of solid-phase extraction (SPE) methods is described. The semiautomated scheme allows for the simultaneous testing of multiple chemistries using a custom multiple-sorbent 96-well method development plate. Optimized extraction conditions for up to five analytes are determined in a single 2.5-h experiment. The experiment can be tailored to d...

Bioanalytical method validation

A syntetic discussion on bioanalytical methods validation is presented from the point of view of regulatory documents, scientific articles and books. The validation parameters are described, together with an example of validation methodology applied in the case of chromatographic methods used in bioanalysis, taking in account to the recent Food and Drug Administration (FDA) guidelines and docum...

Theoretical models in LC based bioanalytical method development.

Bioanalytical method development largely depends on the experience and the preference of the developer. Mathematical models could help in selecting the proper conditions to develop a selective and robust method, using liquid chromatography, liquid-liquid extraction, solid phase extraction and protein precipitation. This paper reviews the literature providing relevant equations and algorithms to...

Bioanalytical Method Development and Validation of Biosimilars: Lessons Learned

[1]. In order to evaluate biosimilarity between an innovator and biosimilar product, the FDA recommended a stepwise, riskbased totality of evidence approach. In addition to extensive structural and functional characterization, effort must also be made on preclinical development in terms of animal toxicity studies and the assessment of pharmacokinetics (PK) and immunogenicity. Although there are...