Transcription of JOINT POSITION PAPER FROM EXCIPIENT …
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JOINT POSITION PAPER FROM EXCIPIENT …
JOINT POSITION PAPER FROM EXCIPIENT manufacturers , 1 DRUG PRODUCT manufacturers AND USP ON 2 PHARMACEUTICAL EXCIPIENT 3 TESTING AND CONTROL STRATEGIES; 4 BASED ON A 5 PQRI SURVEY AND WORKSHOP 6 7 Authors: Brian Carlin, Dale Carter, Gregory Larner, Kevin Moore, Barry Rothman, David 8 Schoneker, Catherine Sheehan, Rajendra Uppoor, Phyllis Walsh*, and Robert Wiens* (members 9 of the PQRI EXCIPIENT Working Group, *co-chairs) 10 11 The PQRI1 Workshop on EXCIPIENT Testing and Control Strategies was held October 11-12, 2006 12 in Bethesda, MD. The workshop was designed to provide industry, FDA2 and USP3 an 13 opportunity to interact on topics related to the testing and release of pharmaceutical excipients . 14 The results of a recently conducted PQRI industry-wide survey4 on the control of pharmaceutical 15 excipients were discussed in detail.
1 JOINT POSITION PAPER FROM EXCIPIENT MANUFACTURERS, 2 DRUG PRODUCT MANUFACTURERS AND USP ON 3 PHARMACEUTICAL EXCIPIENT 4 TESTING AND CONTROL STRATEGIES; 5 BASED ON A 6 PQRI SURVEY AND WORKSHOP 7 8 Authors: Brian Carlin, Dale Carter, Gregory Larner, Kevin Moore, Barry Rothman, …
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