How to Integrate Quality by Efficient Design (Qbed) in Product Development

ISBN-13: 9780128168134 / Angielski / Miękka / 2019 / 274 str.

Bhavishya Mittal

Spis treści

1. Health Care: A Societal Benchmark2. Pharmaceuticals: A Highly Innovative Business3. Pharmaceutical Productivity: Challenges and Opportunities4. QbD: A Welcome Evolution5. QbED: An Emerging Concept6. Adaptive Product Designs: A Wave of the Future7. Patient-Centric Drug Product Designs: A Business Necessity8. Manufacturing Excellence: Only Road to Continual Improvement9. Case Studies and Supplemental Resources

O autorze

Bhavishya Mittal is an Associate Director in the Oral and Implants Product Development Department at Allergan Pharmaceuticals in Irvine, CA. Prior to Allergan, Bhavi worked at the US Food and Drug Administration (FDA), Takeda Pharmaceuticals and Astellas Pharmaceuticals. Bhavi has a PhD in Materials Engineering from the Pennsylvania State University and a BS in Chemical Engineering from Regional Engineering College, Jalandhar (India). Bhavi has 16 years of industrial experience in formulation and process development of various solid oral dosages of small therapeutic molecules (oncology, inflammation, and CNS indications) aimed for NDA and ANDA filings. He is the past Vice Chair for the Manufacturing Sciences and Engineering (MSE) section of AAPS. His research interests include formulation design, process engineering, scale-up/tech-transfer, and computational modeling of pharmaceutical unit operations for solid oral dosage manufacturing. In addition to technical topics, Bhavi maintains an active interest in general risk mitigation strategies, efficient outsourcing management, business analytics, strategic decision-making sciences, and financial engineering.