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Activity Number:
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93
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 30, 2007 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309354 |
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Title:
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Some Useful Experimental Designs in Method Transfer Experiments
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Author(s):
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Jyh-Ming Shoung*+ and Stan Altan
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Companies:
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J&JPRD and J&JPRD
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Address:
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9 Saratoga Court, East Brunswick, NJ, 08816,
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Keywords:
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Abstract:
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Method Transfer is a part of pharmaceutical development in which an analytical (chemical) procedure developed in one laboratory (typically the research laboratory) is about to be adopted by one or more other laboratories (production or commercial operations). The objective is to show that the recipient laboratory is capable of performing the procedure in an acceptable manner. Acceptability is typically decided on the basis of an equivalence test. But in the course of carrying out a method transfer, other questions may arise related to fixed or random factors of interest, such as analyst, apparatus, batch, supplier of analytical reagents etc. Estimates of reproducibility and repeatability may also be of interest in the course of carrying out the method transfer. This presentation will focus on the application of various block designs.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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