Course Overview
SwRI is hosting an Introduction to Pharmaceutical Development in-person 2-day workshop at our site in San Antonio, TX, USA. The workshop will introduce participants to a variety of topics starting with the active pharmaceutical ingredient (API) and finishing with regulatory approval. Workshop content is structured to walk participants through the process of selecting an API, synthesizing the API, formulation, analysis, testing (e.g. clinical trials), and regulatory support. Experienced SwRI staff will share perspectives and insight, along with facility tours and process demonstrations.
Location
Southwest Research Institute
6220 Culebra Road • San Antonio, TX
Cost
The course cost is $895 USD per registrant. Registration includes course instruction, training materials provided to download, facility tour, lunches, and process demonstrations.
Course Topics
- Identify
- API Modeling
- API Generics, biologics, repurposing, orphans
- Synthesize
- API Synthesis
- CMC (Chemistry, Manufacturing, and Controls)
- Formulate
- API Pre-formulations
- API Formulations for drug delivery
- Micro/nanoencapsulation
- Test
- Analytical (purity, impurities, stability, etc.)
- Pre-clinical, clinical trials
- Manufacture
- cGMP manufacturing
- FDA, INDs, Case Studies, Recalls
Downloads
A downloadable PDF of the Course Agenda is available.
For more information and updates about our pharmaceutical development services, please contact James Oxley, Ph.D. or visit pharmdev.swri.org.