JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives

To learn the generic drug product development process, dosage form design and

development, analytical method development and dossier approval process.

Course Outcome

The knowledge of the students is enhanced with the clear information about the

generic product development.

UNIT - I

• a. Concept of generic drug product development, Hatch-Waxman act and its amendments.
• b. History of generic product development in US

UNIT - II

Design of dosage form to meet equivalence to reference listed drug, product development steps, formula optimization, process optimization and packaging selection.

UNIT - III

Analytical method development for verification and validation for active ingredient, in-process samples and finished dosage forms.

UNIT - IV

• a. Stability studies on active ingredient and finished dosage forms, accelerated stability studies, stability studies at different conditions, determination or expiration date.
• b. Scale up studies to optimize manufacturing process and execution of exhibit batches.

UNIT - V

• a. Bioequivalence studies, various designs of bioequivalence studies, bioequivalence criteria and in-vitro tests to ensure bioequivalence of test product.
• b. Introduction to electronic Common Technical Document (eCTD), various modules and the important information in each module.
• c. Drug product approval process in India and US.

REFERENCE BOOKS

• 1. Generic Drug product Development: Solid oral dosage forms-Leon Shargel.
• 2. ICH guidelines. R17 B. PHARMACY III YEAR