CRED Getting the CMC Dossier Right 2024

28/08/2024

3.2.P.2 Pharmaceutical Development

Drug Product

● Formulation development – extent depends on type of product/application.

● QC dissolution method and bioequivalence (when applicable)

Equivalence demonstration from quality perspective (solid oral dosage forms):

Acceptability biobatches + dissolution profiles + biowaiver of strength (when applicable)

Guideline on the investigation of bioequivalence: requirements in vitro dissolution tests, dissolution similarity, biowaivers & discriminatory power of QC dissolution method.

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

11

3.2.P.2 Pharmaceutical Development

CASE STUDY

QC dissolution method: 250 ml pH 6.8 Phosphate buffer + 4.0% SLS, paddle apparatus, 75 rpm, 37 ° C

No SLS

RSD values? Plateau reached?

Alejandro Montón Silva

The Organisation for Professionals in Regulatory Affairs

12