Laboratory work

Biopharmaceutical summary

This step consists on gathering the essential information needed to understand the drug being studied.Deliverables of this step:A report on the drug substance and drug product properties.Predict the drug behaviour

Drug screening

HPLC method development

Deliverables

Equilibrium solubility

Dissolution

Objectives

Target "objective" media

Assess dissolution to 100% potential

Evaluate discrimination potential

Resources

Drug API

Enough drug for calibrators

2+ drug product formulations

Activities

Method development

Standard setup

Standard conditions

Analytical method

1 step method protocol