Applications of IVIVC in Formulation Development - PQRI
Applications of IVIVC in Formulation Development - PQRI
Applications of IVIVC in Formulation Development - PQRI
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Controlled Release <strong>Formulation</strong> – IR or MR<br />
PK and PD pr<strong>of</strong>ile is that <strong>of</strong> an IR drug product<br />
Cl<strong>in</strong>ical safety and efficacy pr<strong>of</strong>ile is that <strong>of</strong> an IR drug<br />
product<br />
Product does not meet requirements <strong>of</strong> MR dosage<br />
formulation<br />
No reduction <strong>in</strong> dos<strong>in</strong>g frequency<br />
No reduction <strong>in</strong> plasma concentration fluctuations<br />
No modified release characteristics exhibited <strong>in</strong> plasma concentration-time<br />
pr<strong>of</strong>ile<br />
Are changes to formulation subject to SUPAC-IR<br />
guidance or SUPAC-MR guidance
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