Formulation and Quality – Chemical
2019 PharmSci 360
Bioavailability/Bioequivalence (BA/BE) studies play a major role through the development, regulatory approval and clinical application of both new drugs and their generic equivalents. BA/BE studies rely on the accurate measurement of drug concentrations in biological samples such as plasma, serum and tissue. To achieve this goal, a precise and robust bioanalytical method is pivotal. In recent years, the quality by design (QbD) approach has been adopted for analytical method development, which can help to identify and minimize sources of variability, enhance method robustness and best ensure the intended method performance. OTR scientists have developed and validated a bioanalytical platform with a simplified QbD approach. Four case studies are discussed here to demonstrate the success application of this platform for medical countermeasure formulation development, pediatric formulation optimization and formulation assessment of intravitreal implant in animal models to provide rapid response to regulatory issues and public health concerns.