Module 9 2021

24/03/2021

Reference requirements

In-House reference standard (ICH Q6B) • Needed at early stage of development (both of product and assay) • Better continuity of data when same standard used • More likely that early batches differ… so may need to replace initial in-house reference with representative production/clinical material (ICH Q5E)

The Organisation for Professionals in Regulatory Affairs

9

9

Bioassays – life cycle I

Preclinical (early batch material)

Research Development

The Organisation for Professionals in Regulatory Affairs

10

10

5