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求Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition (Drugs and the Pharmaceutical Sciences) (Volume 3) 2nd Edition https://www.amazon.com/Generic-Drug-Product-Development-Pharmaceutical/dp/1420086359/ref=sr_1_3?ie=UTF8&qid=1523334534&sr=8-3&keywords=Generic+Drug
Major topics discussed include:
- Active pharmaceutical ingredients
- Experimental formulation development, including a new section on Quality by Design (QbD)
- Scale-up
- Commercial product formulation
- Quality control and bioequivalence
- Drug product performance
- ANDA regulatory process
- Post-approval changes
- Post-marketing surveillance
- Legislative and patent challenges
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