Success stories
Partnerships to success
Ghana FDA training
-A five-day training of the clinical assessors of Ghana FDA
- Topics covered included basis of bioequivalence, assessment of the modified-release dosage forms, bioanalysis and bioanalytical method validation, narrow therapeutic index drugs, highly variable drugs.
-Comparison of EMA and US FDA practices
- Training included case studies and assessment of the dossiers
Justification of Tmax bioinequivalence
-Product-specific bioequivalence guideline in place for the molecule in question
- Tmax bioinequivalence raised as a major objection during the procedure
- Justification was based on clinical irrelevance and lack of PK/PD correlation
-Justification was accepted and the product was registered
Audit of a non-EU dossier of a complex formulation
- The dossier audit was ordered by an EU client for the purpose of in-licensing
- Reference product was not from EU, comparative PK study was performed in non-EU population
-Solution for a bridging strategy from non-EU to EU reference was recommended
- Extrapolation of the PK study results to Caucasian population was done to exclude the influence of genetic differences on the PK of the active substance
- The product was successfully registered
CMDh referral for modified-release dosage form
-In vitro dose dumping tested, release in alcohol different to the reference product. Major objection raised.
- Justification was based on the clinical significance of the dose dumping test findings.
- Clinical effects of the concomitant administration of a drug with alcohol were summarized in the response
- Additional in vitro data generated
-Referral successfully resolved, product obtained marketing authorisation
Medical writing for gastroresistant formulation
-Legal basis is well-established use, no PK or clinical data generated. Evidence on the PK, efficacy and safety of the product are based on the published literature
-The critical part of the Clinical Overview is bridging of the to-be-marketed product to the published evidence
- Comprehensive search of EU market for similar products performed
- Qualitative composition of marketed products was compared to the to-be-registered product
-Clinical consequences of bioinequivalence assessed
-No major objection raised on the bridging strategy