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The Specification of a drug substance or a drug product contains three basic elements: a List of Tests (or Attributes), References to Test Methods and Acceptance Criteria. The ICH Guidelines for new chemical entities (Q6A) and new biological entities
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::13acd989c98e18b837f63fc909c5d651
https://doi.org/10.1016/b978-0-08-098350-9.00002-3
https://doi.org/10.1016/b978-0-08-098350-9.00002-3
Autor:
Daniel W. Armstrong, James Bergum, Beth Ann Brescia, Peter Bryan, Todd L. Cecil, Ping Chen, Eliza N. Fung, Vivian A. Gray, Brian He, Laureen E. Little, David K. Lloyd, James V. McArdle, Kurt L. Moyer, Bradford J. Mueller, Nilusha L.T. Padivitage, Ernest Parente, Robyn L. Phelps, Shelley R. Rabel Riley, Christopher M. Riley, Thomas W. Rosanske, James Scull, Krzysztof Selinger, Eric B. Sheinin, Pamela A. Smith, Jonathan P. Smuts, Patrick A. Tishmack
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::189c3cdf8d856264725f8cc2505af9d0
https://doi.org/10.1016/b978-0-08-098350-9.01002-x
https://doi.org/10.1016/b978-0-08-098350-9.01002-x