FDA Views Clinical Linkages as Key QbD Implementation Gap

As quality-by-design (QbD) implementation progresses, FDA is becoming aware of the scientific gaps that still need to be filled in. One area in particular that has generated considerable attention among industry and regulators is “understanding the link between what that product is and how it works in the patient – that is, integrating the field of biopharmaceutics into QbD,” ONDQA Acting Deputy Director Christine Moore stressed at a recent conference.


The importance of the issue and the challenges around addressing it were brought to the fore as CDER moved the spotlight onto QbD for large molecules and what OBP needed to achieve in its biotech pilot (IPQ, Sept./Oct. 2007 and Sept./Oct. 2008).


Understanding complex products and processes and the quality/safety/efficacy linkages is a place where FDA has more to learn, Moore acknowledged. ONDQA faces similar complexities to those in the biotech arena in terms of complex dosage forms such as transdermal patches, the deputy director noted. The use of models and statistical approaches such as Bayesian analysis in understanding design space is another step on the learning curve, she pointed out.


[Editor’s Note:  The May issue of IPQ includes comments by CDER’s Moore on biopharmaceutics linkages as part of the issue’s in-depth analysis of the impact the new QbD paradigm is having on the initiatives and dialogue around reshaping the CMC review process.]