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Industrial Pharmacy II: From Pilot Plant to Regulatory Affairs: From Pilot Plant to Regulatory Affairs

Industrial Pharmacy II: From Pilot Plant to Regulatory Affairs: From Pilot Plant to Regulatory Affairs in Bloomington, MN
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A comprehensive guide to the essential industrial aspects of pharmaceutical manufacturing, this book takes readers through the
entire journey of drug development
, from
pilot plant scale-up to regulatory approvals.
✔️ I
n-depth insights into scale-up techniques, technology transfer, and formulation challenges.
✔️
Expert analysis of Good Manufacturing Practices (GMP), Quality by Design (QbD), and regulatory compliance.
Detailed overview of Indian and international regulatory requirements, including CDSCO, FDA, and EMA guidelines.
✔️ Practical case studies and real-world applications to bridge the gap between theory and industry practices.
A must-have resource for
students
,
researchers, faculty, and industry professionals
, this book ensures a strong foundation in Industrial Pharmacy to navigate the highly regulated pharmaceutical sector with confidence.
entire journey of drug development
, from
pilot plant scale-up to regulatory approvals.
✔️ I
n-depth insights into scale-up techniques, technology transfer, and formulation challenges.
✔️
Expert analysis of Good Manufacturing Practices (GMP), Quality by Design (QbD), and regulatory compliance.
Detailed overview of Indian and international regulatory requirements, including CDSCO, FDA, and EMA guidelines.
✔️ Practical case studies and real-world applications to bridge the gap between theory and industry practices.
A must-have resource for
students
,
researchers, faculty, and industry professionals
, this book ensures a strong foundation in Industrial Pharmacy to navigate the highly regulated pharmaceutical sector with confidence.