The 505(b)(2) drug development path, in contrast to traditional development of a new,
Tissue and tumor sample testing are valuable matrix to test for drug levels (PK) and biomarkers (PD).
Designing a tissue assay in accordance to the FDA bioanalytical method validation (BMV) guidance involves three key questions.
Measuring new biotherapeutic modalities such as cellular therapies are not well defined in the regulatory landscape.
In pursuit of KCAS’ Mission to provide reliable and defendable data,
Immunogenicity, why do we keep talking about it? Immunogenicity can,