#يحدث_الآن
أقوى مادة علمية فى علم الــــ
Formulation and Developing Pharmaceutical generic product
Level I (Basic level)
Course Objectives:
The course intends to give valuable theoretical and practical insights about developing different dosage forms, assessment of these products, fulfillment regulatory affairs, exportation requirements and trouble shooting of different dosage forms.
Course Contents:
ICH Q8
Regulatory submission
API specification
Innovator selection and characterization
Pre-formulation steps including Phase I
Formulation development including Phase II and Phase III
Formulation assessment against innovator including Bio-equivalence & Bio-waiver studies
Level II (Advanced level)
Course Objectives:
Cover formulation development, package development, developing specifications, regulatory submission, scale up issues, trouble shooting for problems raised during development/scale up/production.
Course Contents:
Effective formulation development and package development
Quality by Design
Documentation including (IPC, Product development report, Sampling plan, TTR, PBPR, and Mater formula)
Formulation scale up
Technology Transfer from R&D to Production
Trouble shooting
MOH re-registration requirements