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Pharmaceutical Product Development: In Vitro-In Vivo Correlation
Series: Drugs and the Pharmaceutical Sciences
- Dr Dakshina Murthy Chilukuri (Food and Drug Administration, Herndon, VA, USA)
- Dr David Young (AGI Therapeutics, Columbia, MD, USA)
- Dr Gangadhar Sunkara (Novartis Pharmaceuticals, East Hanover, NJ, USA)
- Pub Date
- February 2007
- Series
- Drugs and the Pharmaceutical Sciences
- Volume
- 165
- Pages
- 224
- Size
- 6 x 9
- ISBN
- 9780849338274, 0849338271
The pharmaceutical industry is constantly pressured to quickly bring drugs to market and reduce costs to maximize ROI and bring treatments to patients sooner. To achieve this, pharmaceutical scientists are addressing physicochemical and biological issues in the early developmental stages to avoid future problems.
A multidisciplinary tool that has been successfully applied in testing effectiveness of a drug substance and the only available text on IVIVC, it illustrates the importance of IVIVC in drug development and covers advances and regulatory perspectives on the role of IVIVC in the pharmaceutical industry.
With contributions by product development experts, this guide provides:
• theory and application of IVIVC
• mathematical algorithms for model development and validation
• IVIVC in early phases of drug discovery and special drug delivery systems
• regulatory guidance on the use of IVIVC worldwide
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