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Erythro DPK Presentation
Erythro DPK Presentation
ERYTHROMYCIN USING
DERMATOPHARMACOKINETIC METHOD
Definition of Bioequivalence
Pharmacokinetic Clinical/PD
Dosage Form Measurement Measurement
Performance
Dose ln Dose
Model of Topical (Skin) Dosage
Form Performance
Clinical/PD Pharmacokinetic
Dosage Form Measurement Measurement
DPK
Performance
ln Dose Dose
Research Concern
Is the DPK method an appropriate approach for
establishing bioequivalence of topical drug
products?
Are results and conclusions derived from the DPK
method consistent within and between
laboratories?
Can DPK methodology be established in any
laboratory or CRO with a reasonable amount of
time, effort and expense?
Objective
To develop and validate simple, specific and sensitive analytical
method in vitro for the estimation of Erythromycin in human
Stratum corneum.
To assess the in vivo pharmacokinetics of two Erythromycin
Marketed formulations by Dermatopharmacokinetic methods
using Indian male subjects to meet the following sub-objectives:
Efficacy: To assess the pharmacokinetic profile of Erythromycin
Marketed formulations by Dermatopharmacokinetic methods.
Safety: To monitor the safety of the study formulations in subjects.
To investigate the in vitro penetration characteristics of the two
Erythromycin formulations and to check if any in vitro-in vivo
correlation could be established.
Study Design
Analytical Method for Sample
Analysis
For better sensitivity and accuracy, HPLC method
for analysis of Erythromycin from SC samples was
developed and validated.
Both the methods were developed using working
standard of Erythromycin and validated for
accuracy for Erythromycin estimation for the
formulations used in the study.
Comparative DPK Results
Comparative DPK Results
Ln(AUCINF_o
bs) A B
Ln(AUClast) A B
Ln(Cmax) A B
In vitro findings
IVIVC