Module 3 2019

Comparison Traditional vs RTR(t) Control Strategy

Background 1: UK-xxxxxx, wet granulated tablet product, high dose (500 mg +), high drug loading (60%) ● Formulation containing Avicel, Lactose, PVP, Croscarmellose Sodium and Magnesium Stearate ● Compound entering Development Phase

Background 2: UK-yyyyyy, direct fill capsule, low dose (5-10 mg), standard / low drug loading (5%) ● Formulation containing Avicel, Lactose, Maize Starch, Talc ● Compound in production

The Organisation for Professionals in Regulatory Affairs

Made with FlippingBook - Online Brochure Maker