Success Story1 - Pharmadesk has delivered first file iron sucrose study to USFDA for its client

Challenge

Analysis of endogenous molecule, Iron Sucrose which is an element and required thorough understanding of various pathways and cycles.

Solution

We were working on this molecule since last 10 years and our experience has helped us in gaining the essential skills and knowledge required to understand the subject deeply and handle challenges associated with this molecule. We were familiar with the behaviour of Iron in systemic circulation. Strategical incorporation of positive control and negative control during analysis ensured the correctness of data obtained.

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Challenge

Iron is not available in single form for analysis, it is always present in either complex or bind or free form.

Solution

We understood the pathway / cycle of iron circulation in human body which helped us to measure the total iron and transferrin bound iron analyte to prove bioequivalence.

Service used for this solution

Challenge

Widely used technique in bioanalysis like LCMS cannot be used as tool to quantitate iron. ICPMS also has its own challenge in quantifying transferrin bound iron is not acceptable to agencies.

Solution

We had developed a scientific method was capable to estimate different complexes of iron present in the circulatory system individually and this was used throughout our experience of iron sucrose biostudies. Our experience with iron sucrose molecule especially with pharmacokinetic profile had helped us in predicting the exact sample size to prove bioequivalence.

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Challenge

Dosing of large number of subjects with proper execution of clinical part is a challenge.

Solution

Mobilising and handling of large number of subjects for a single biostudy was a difficult task and required a lot of planning and management. We were fully aware of this and had executed such studies with proper action plan.

Service used for this solution

Challenge

Due to lack of PK data available in public domain, predicting exact sampling time points to meet the bioequivalence is itself a great task.

Solution

We used specialised dosing procedure (intravenous dosing) which helped us to administered accurate dose with precise rate to get an accurate Cmax.

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Challenge

Effect of haemolysed samples and turbidity of serum sample needs to be addressed as this may have potential effect on analyte detection ability of analytical method.

Solution

We faced this issue during our early stages, for which we performed experiments with certain criteria and acceptable limits. However, slowly and steadily, we have currently overcome this issue by designing and performing additional experiments as an addendum to the method validation.

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Challenge

Regulatory queries on the submitted ANDA application.

Solution

Our responses to the observations/queries were very clear and precise with proper supporting evidences.

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Benefits

Our planning in the volunteer recruitment and management helped our client to achieve sufficient evidence to prove bioequivalence. The colorimetric method developed by us was acceptable to the regulatory authorities with whom the ANDA dossier is under review process. The dosing schedule with selection of accurate sampling time points has helped in getting desirable pharmacokinetic profile for both the analytes - total iron and transferrin bound iron. If any haemolysed samples were reported, based on the experiment accuracy and recovery results, they were excluded from statistical calculations resulting the bioequivalence study to meet the acceptance criteria.
For the every response we shared with regulatory agencies, we received positive feedback since we were able to explain them how iron behaves in the systemic circulation and how we performed the study.
In every study, based on what we understand and learn, we were able to pre-define and predict potential hurdles in the study which helped us to provide complete solution to our existing client and future clients enabling them to obtain marketing authorisation and minimise rejection of formulation.

Pharmadesk delivered first to file iron sucrose study to USFDA for its client.

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