final drug product / food effect / pharmaceutical development / improved processing efficiency / drug product / particular product / example pharmaceutical development report / pharmaceutical development approaches / pharmaceutical development report / manufacturing process / /
MedicalCondition
hepatic insufficiency / /
Organization
FDA / N/A Lab / Scale N/A N/A N/A Lab / /
Person
Each / Tablet Module / /
Position
Executive / /
Product
Water Half tablet / HCl Half tablet / The tablet / Prototype tablet / F-2 / Whole tablet / F-3 / Brand IR Tablets / F-1 / Brand MR Tablets / Water Whole tablet / Pilot / pH 6.8 / F-1 Development / Example QbD MR Tablet / White capsule / HCl Whole tablet / pH 4.5 / Example IR Tablets / Example MR Tablets / Half tablet / Brand MR Tablet / F-3 Development / MR Tablets / /
Example QbD MR Tablet Module 3 Quality 3.2.P.2 Pharmaceutical Development Quality by Design for ANDAs: An Example for Modified Release Dosage Forms Introduction to the Example