Draft guidance for industry extended-release solid oral dosage forms. Development, evaluation and application of in vitro-in vivo correlations.

H Malinowski; P Marroum; V R Uppoor; W Gillespie; H Y Ahn; P Lockwood; J Henderson; R Baweja; M Hossain; N Fleischer; L Tillman; A Hussain; V Shah; A Dorantes; R Zhu; H Sun; K Kumi; S Machado; V Tammara; T E Ong-Chen; H Mahayni; L Lesko; R Williams

doi:10.1007/978-1-4684-6036-0_25

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Draft guidance for industry extended-release solid oral dosage forms. Development, evaluation and application of in vitro-in vivo correlations.

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Administration, Oral Chemistry, Pharmaceutical Data Interpretation, Statistical Delayed-Action Preparations Drug Approval Drug Industry Humans Hydrogen-Ion Concentration In Vitro Techniques Quality Control Terminology as Topic United States United States Food and Drug Administration Comparative Study Journal Article

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H Malinowski, P Marroum, V R Uppoor, W Gillespie, H Y Ahn, P Lockwood, J Henderson, R Baweja, M Hossain, N Fleischer, L Tillman, A Hussain, V Shah, A Dorantes, R Zhu, H Sun, K Kumi, S Machado, V Tammara, T E Ong-Chen, H Mahayni, L Lesko, R Williams. 1997. Draft guidance for industry extended-release solid oral dosage forms. Development, evaluation and application of in vitro-in vivo correlations.. https://doi.org/10.1007/978-1-4684-6036-0_25

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