There are no absolute
rules governing the size of the first dose
administered to humans. The FDA has recently
issued guidance on estimating Maximum Safe
Starting Dose (MRSD), which is assessed
from the NOAEL from pre-clinical studies.
The Human Equivalent Dose (HED) is calculated
using body surface area conversions, generally
MRSD is 1/10th HED. However there are occasions
when BSA conversions are not appropriate.
Each dose increment is typically two-fold,
but less aggressive regimens may be appropriate
for classes of drug that may cause life-threatening
toxicity, as is the case with anti-arrhythmic
compounds, for example.
The following are examples of Phase 1 studies
carried out IMPs/NCEs:
Tolerability
and pharmacokinetics of escalating
single doses
Tolerability and pharmacokinetics
of repeated doses (usually given for
12 weeks)
Pharmacodynamics of single doses
Pharmacodynamics of repeated doses
Relative bioavailability of simple
solution of drug compared with tablet,
capsule or other formation
Absolute bioavailability (only possible
if an intravenous formulation can be
given)
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