Journal of Pharmaceutical Care & Health Systems
Open Access
ISSN: 2376-0419
ISSN: 2376-0419
Michael Zhou
Posters-Accepted Abstracts: J Pharma Care Health Sys
Pharmaceutical and biopharmaceutical industries have led global initiatives to develop consensus around acceptable benchmark practices applicable to standardizing laboratory and good management systems for analytical and bioanalytical studies and data management in support of discovery, preclinical and clinical trials. Recent issues with analytical and bioanalytical support (novel technologies, LBAs, chromatographic based assays and so on) demonstrate the additional need for a robust quality standard for analysis and bioanalysis of biotherapeutics. Industry-wide acceptance and application of a new quality standard would assure the consistency and quality of data, applications, and products approved for public use by regulatory agencies. In addition, common issues encountered in analytical and bioanalytical assays such as selection of the reference standard curve and appropriate QC materials, fit-for-purpose assay acceptance criteria, and the pros and cons of utilizing commercial assay kits will also be discussed. The presentation will rely heavily on real life case study examples to illustrate the concepts of fit-for-purpose assay development and validation, and successful implementation of new techniques and platforms in drug development. Topic would include talks on special considerations when developing and validating assays for quantitation of analyte(s) of interest. Additional discussion points would be handling data analysis and reduction / integration to simulate PK/PD modeling for statistic evaluation. Regulatory perspectives on emerging techniques and platforms will be also discussed accordingly.