Bioanalytical assay validation parameters re-visited: perspectives on stability studies.
Bioanalytical assay validation for plethora of parameters is considered vital for the reliable and accurate generation of raw analytical data used for pharmacokinetic characterization of analytes. Although the validation parameters have been widely accepted, the intent of this communication is to provide some perspectives on the commonly followed approaches for stability studies (i.e. freeze-thaw and long-term freezer stability studies). The proposed discussion is intended to stimulate the thinking process to cut down on the extra work and/or maximize the efficiency in the bioanalytical work. Additionally, the availability of new emerging technological know-hows and latest nuances in the field should provide the necessary impetus to innovate and articulate strategies for smart assay development/validation work for analytes.
Srinivas
Nuggehally R
NR
Integrated Drug Development, Suramus Biopharm, 77, 10th Cross, 29th Main, J.P. Nagar I Phase, Bangalore 560 078, India. srini.suramus@yahoo.com
D001709:Biotechnology / Q000379:methods* / Q000592:standards; D004355:Drug Stability; D005615:Freezing; D010599:Pharmacokinetics; D015203:Reproducibility of Results; D013048:Specimen Handling / Q000379:methods* / Q000592:standards