BIOT1400
DRUG DEV PROCESS & REGULATIONS
- Department
- Biotechnology
- Terms offered
- 1
- Data refreshed
- Jun 27, 2026
Description
This course will provide the milestones of the scientific and regulatory aspects in drug development. It will emphasize the quality controls and processes, including Good Documentation Practices (GDP), that are needed in this highly regulated endeavor, for small molecules, bio-therapeutics, and new technology such as gene therapy. Furthermore, the use of sensors, omics information, and other new approaches in drug development will be discussed.
Syllabi
Sign in with your @clarku.edu email to view syllabi.
Offering history & forecast 2025
2025
| Year | Fall | Spring | Summer | Intersession |
|---|---|---|---|---|
| 2030 | 2030 Fall: not enough history to forecast. | 2030 Spring: not enough history to forecast. | 2030 Summer: not enough history to forecast. | 2030 Intersession: not enough history to forecast. |
| 2029 | 2029 Fall: not enough history to forecast. | 2029 Spring: not enough history to forecast. | 2029 Summer: not enough history to forecast. | 2029 Intersession: not enough history to forecast. |
| 2028 | 2028 Fall: not enough history to forecast. | 2028 Spring: not enough history to forecast. | 2028 Summer: not enough history to forecast. | 2028 Intersession: not enough history to forecast. |
| 2027 | 2027 Fall: not enough history to forecast. | 2027 Spring: not enough history to forecast. | 2027 Summer: not enough history to forecast. | 2027 Intersession: not enough history to forecast. |
| 2025 | Not offered | 1 section | Not offered | Not offered |
Forecast Under 15% 15–39% 40–69% 70–89% 90%+ Not enough history
Fall Spring Summer Intersession Darker means more sections Not offered No data for term
Future estimates combine recent offering frequency with detected multi-year cycles. Hover a cell for confidence and evidence; low-confidence estimates are marked with ~.
Meeting times
Most recent first- Wed, 6:30 PM–9:30 PM ONLINE 2025
| Term | Professor | Type | Credits | Enrollment | CRN |
|---|---|---|---|---|---|
| Spring 2025 | Walt P. Carney | Online | 1 | 3 of 20 enrolled | 33935 |