success-story
EMEA granted MA to client with single BE study for oncological product, saving Millions of pounds.

Challenge

Diethylstilbestrol is an anticancer drug and no specific guidance is available from neither EU EMEA nor US FDA to conduct BE study.

Solution

Challenge

Using scientific literature and control correspondence we convinced the agency on the risk benefit ratio to conduct biostudy on healthy subjects. Our scientific rationale captured in the protocol for conduct of study in healthy volunteers was well accepted by regulatory authority.
A dose of 1 mg was estimated to be safe dose in healthy subjects for biostudy based on scientific discussion and animal studies. This dose ensured that no adverse effects will be there in the participating volunteers.

Service used for this solution

Challenge

Approval from DCGI and IEC for biostudy.

Solution

Challenge

Scientific discussion, rationale for study in healthy subjects and supportive animal data was shared with DCGI and IEC during application.

Service used for this solution

Challenge

Estimating appropriate sampling time points as no pharmacokinetic data available in the public domain

Solution

Challenge

Based on our understanding and expertise, we predicted the sampling time points for pilot study.

Service used for this solution

Challenge

Designing bioequivalence study as no pharmacokinetic data available in the public domain.

Solution

Challenge

Pilot study was designed using a normal and standard method and based on our understanding and expertise, we predicted the sampling time points for pilot study.

Service used for this solution

Challenge

Execution of study in hospital setup considering threat of adverse events.

Solution

Challenge

Subjects were dosed in hospital setup with proper safety monitoring using cardiac monitors, intenvists available for dosing, frequent vital signs measurements, ECG recording etc.   We have approached and consulted national as well as international oncologists and obtained their opinion on risk analysis and applied the same for design and conduct of this biostudy.

Service used for this solution

Benefits

  • Successfully completed one pilot and one pivotal study on healthy subjects which further received approval from EMEA. with one query from EMEA requesting justification for conducting biostudy on healthy subjects. A scientific justification was provided with relevant data from the public domain which was accepted and currently the product is in EU market.
  • None of the enrolled subjects were reported to have any adverse effects nor there were any dropouts.
  • No serious adverse events were reported as proper precautionary measures were taken while conducting the study in ICU setup.
  • Scientific discussion, rationale for study in healthy subjects, study design and supportive animal data was also shared with DCGI and IEC. Based on presented data and safety precautions, DCGI and IEC allowed us to conduct pilot BE study in healthy volunteer and based on safety results of pilot study, further approval to conduct pivotal BE study in greater population was obtained.
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