QPS offers fully integrated front-to-end clinical and bioanalytical services for iron sucrose studies based on a vast track record.

1. Iron Sucrose
iron.sucrose@qps.com | www.qps.com | +1.417.831.2048 | +31.50.304.8000
Full-service bioequivalence studies
Iron is primarily important to the human body because it is the main constituent of
Hemoglobin, Cytochrome, and other components of respiratory enzyme systems.
Iron sucrose is a complex of ferric hydroxide, Fe(OH)3, in sucrose, used intravenously to treat
iron deficiency anemia in hemodialysis patients receiving supplemental erythropoietin therapy.
QPS offers fully integrated front-to-end clinical and bioanalytical services for iron sucrose
studies based on a vast track record.
Clinical conduct
QPS’ standard study is designed to
assess bioequivalence between 2
two products through PK
endpoints of AUC and Cmax for
Baseline-adjusted total iron (BATI)
and Baseline-adjusted Transferrin-
bound iron (BATBI) following a
dose administered undiluted as a
slow IV injection over 2 minutes.
The design is a randomized,
parallel, single-dose, single center,
open-label study in adult healthy
male and female subjects, who will
stay in the clinical unit for 2 nights.
The investigator will screen to
enroll 60 subjects to obtain at
least 56 evaluable subjects upon
study completion (including
replacement of dropped subjects).
Front and back-end services
In addition to clinical and
bioanalytical conduct, QPS’
package also includes the pre-
study and post study activities,
including clinical study protocol,
IRB submission, regulatory
authorities notification, data
management, biostatistics and
medical writing.
The package is ready for use
before study conduct, which
guarantees fast database lock and
clinical study report generation.
Bioanalytical services
The primary PK assessments are
total iron and transferring-bound
iron, for which QPS has validated
bioanalytical methods available.
The methods, applying ICP-MS and
spectrophotometry, respectively,
comply with current FDA and EMA
validation guidelines. Certified sera
are used for Quality Control.
The methods have been designed
for high-throughput bioanalysis to
minimize reporting times.
The bioanalytical results from 3
pre-dose and 17 post-dose
samples enable the calculation of
BATI and BATBI and PK
parameters based on these data.
Differentiating expertise
QPS’ unmatched combination of
an experienced clinical site and an
ICP-MS based bioanalytical facility
provides our customers the best
conditions for reliable study
conduct and best clinical outcome.
This is linked with optimized
planning by seamlessly connecting
bioanalysis and clinical research
services to clinical conduct, as all
services will be done in-house.
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Concentration(ng/mL)
Time (hr)
Iron Sucrose BE study
Formulation 1
Formulation 2