| 학회 | 한국화학공학회 |
| 학술대회 | 2016년 가을 (10/19 ~ 10/21, 대전컨벤션센터) |
| 권호 | 22권 2호, p.2614 |
| 발표분야 | 제13회 약물전달 및 화장품 기술 심포지엄(공업화학부문위원회) |
| 제목 | Systems-based Pharmaceutics and gPROMS FormulatedProducts |
| 초록 | This seminar will firstly introduce the concept of Systems-based Pharmaceutics (SbP), a holistic model-based approach that considers both drug substance and drug product manufacture as well as drug product performance. This approach was defined by Eli Lilly, Pfizer and PSE with the aim of (i) reducing iterations between drug product design and manufacturing process design, and (ii) being able to assess variability in product performance as a result of common cause variability in manufacturing (raw material and process conditions) and patient-to-patient variability. Secondly, SbP will be compared with QbD. It will be shown that its aims are the same, but the approach is significantly different to the prevailing method based on statistical techniques. Consequently SbP can also be thought of as QbD 2.0. The second half of this talk will focus on industrial case studies from AZ, Lilly and Pfizer illustrating the value of mechanistic model-based approaches and the concept of SbP. The final part of this talk will introduce a PSE product gPROMS FormulatedProducts, which makes implementation of the SbP approach accessible to a wider range of stakeholders. |
| 저자 | Dan Braido |
| 소속 | PSE (Process Systems Enterprise) |
| 키워드 | Systems-based Pharmaceutics; SbP; QbD; drug; in-vitro; in-vivo; gPROMS |
| 원문파일 | 초록 보기 |
