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...

Bioanalysis is determining the concentration of drugs and metabolites in biological fluids (i.e. plasma and urine). During the past 15 years tremendous advances in bioanalysis, for example HPLC, auto injectors, data collection systems and robotics has enabled the productivity of the bioanalyst to increase but it still requires considerable manual intervention. This paper describes the rationale...

On the basis of the bond-valence model (BVM) and structure-map technology, the structural stability and formability of ABO(3)-type perovskite compounds were investigated in 376 ABO(3)-type compounds. A new criterion of structural stability for ABO(3)-type perovskite compounds has been established by the bond-valence calculated tolerance factors, which are in the range 0.822-1.139. All global in...

[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...

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...

The 2001 US FDA Bioanalytical Method Validation (BMV) guidance document has been widely accepted and adopted by the bioanalytical community worldwide. As such, it has become the cornerstone of regulated bioanalytical laboratory procedure. In recent years, clarifications to these FDA guidelines and subsequent enhancements were discussed at North American-and European-hosted meetings and conferen...

Lyme disease is a common disease that is faced by the physician but also acts a mimicker of many other disease processes. Facial palsies, especially bilateral, are a relatively rare presenting symptom of Lyme disease and may warrant further investigation. A thorough history and physical examination coupled with precision testing may aid the physician when faced with a patient with the diagnosti...