Regulatory Experience with Continuous Manufacturing and Real Time Release Testing for Dissolution in New Drug Applications
Maziar Kakhi, Jing Li, Angelica Dorantes
Topics & Concepts
BiopharmaceuticsDocumentationDrugFood and drug administrationDissolution testingComputer sciencePharmacologyBusinessProcess managementRisk analysis (engineering)MedicineBiopharmaceutics Classification SystemChemistryBiological activityPharmacognosyProgramming languageIn vitroBiochemistryCrystallization and Solubility StudiesDrug Solubulity and Delivery SystemsInnovative Microfluidic and Catalytic Techniques Innovation