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Biotechnology Operations: Principles and Practices
CONTENTS
1 Introductionto biotechnology operations: planning for success 1-28
2 Project management 29-60
3 Regulatory affairs 61-98
4 Regulatory compliance 99-125
5 Quality systems 127-163
6 Biomanufacture 165-226
7 Quality control 227-275
8 Nonclinical studies 277-314
9 Clinical trials 317-358
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