|
| Art Science and Regulation of Pharmaceutical Unit Operations: Managing Risks by Ensuring "Quality is Built-in". |
|
|
|
|
| On July 11, 2001 at SciTech Center |
|
| Pharmaceutical Products are complex multi-factorial systems whose performance attributes are often difficult to predict from first principles. Over the last four decades significant advances have been made in applying sound scientific and engineering principles to the design and manufacture of optimally performing products. However, it is still perceived by many that the process of pharmaceuticals product development relies more on pharmaceutical "art" than science. |
|
| Such perceptions have profound impact on every aspect of pharmaceutical sciences (e.g. public funding for academic pharmaceutical research and regulatory policies). This presentation will use the Scale-Up and Post Approval Changes (SUPAC) and the Biopharmaceutics Classification System (BCS) guidance document to reflect on: |
|
| (1) issues and perceptions related to the pharmaceutical art vs. Science debate and |
| (2) opportunities for minimizing public risk by ensuring that quality is built-in to products. |
|
| Speaker |
|
| Ajaz S. Hussain Ph.D. |
|
| US, FDA |
