Generic Product Development Detailed Syllabus for B.Tech third year second sem is covered here. This gives the details about credits, number of hours and other details along with reference books for the course.
The detailed syllabus for Generic Product Development B.Tech 2016-2017 (R16) third year second sem is as follows.
B.Tech. III Year II Sem. L/T/P/C
Course Code:PS605 3/0/0/3
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:
- Concept of generic drug product development, Hatch-Waxman act and its amendments.
- 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.
REFERENCE
- Generic Drug product Development: Solid oral dosage forms-Leon Shargel.
- ICH guidelines.
For all other B.Tech 3rd Year 2nd Sem syllabus go to JNTUH B.Tech B. Pharm 3rd Year 2nd Sem Course Structure for (R16) Batch.
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