Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non‐orphan drugs approved by the FDA.

Autor: Hsieh, Julie¹ (AUTHOR), Sahre, Martina¹ (AUTHOR), Yang, Xinning¹ (AUTHOR), Madabushi, Rajanikanth¹ (AUTHOR), Ramamoorthy, Anuradha¹ (AUTHOR) anuradha.ramamoorthy@fda.hhs.gov

Publikováno v: CTS: Clinical & Translational Science. Nov2022, Vol. 15 Issue 11, p2583-2596. 14p.

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Chapter 32 - Phase 1 clinical studies

Autor: Noveck, Robert Joseph, Sahre, Martina Dagmar

Publikováno v: In Atkinson's Principles of Clinical Pharmacology Edition: Fourth Edition. 2022:603-609

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Contributors

Autor: Abernethy, Darrell R., Agoram, Balaji, Allen, John M., Arnold, Mark E., Atkinson, Arthur J., Jr., Bateman, Thomas J., Bergman, Kimberly, Booth, Brian, Boulton, David W., Branch, Robert A., Burckart, Gilbert J., Buschmann, Mary, Carmichael, Owen, Chamberlain, Christine, Chen, Ligong, Daniels, Charles E., Das, Promi, Delfino, Jana G., Van Den Anker, John N., Dreisbach, Albert W., Dyszel, Michael, Earp, Justin C., ElZarrad, M. Khair, Enogieru, Osatohanmwen J., Fletcher, Elimika Pfuma, Foster, David M., Frederiksen, Marilynn C., Galetin, Aleksandra, Garzone, Pamela D., Giacomini, Kathleen M., Gibbs, Megan A., Gilbert, Jack A, Gnjidic, Danijela, Gombar, Charles T., Grant, Denis M., Grudzinskas, Charles, Hamren, Bengt, Holford, Nicholas H.G., Huang, Shiew-Mei, Iacona, Renee, Isoherranen, Nina, Jin, Denise, Jones, Bridgette L., Kearns, Gregory L., Kortepeter, Cindy, Kunkoski, Elizabeth, Lau, S.W. Johnny, Leptak, Christopher, Lertora, Juan J.L., Lesko, Lawrence J., Liu, Jiang, Liu, Qi, Madabushi, Rajanikanth, Miller, Raymond, Mould, Diane R., Muñoz, Monica, Nolin, Thomas D., Noveck, Robert Joseph, Obach, R. Scott, Pacanowski, Michael, Paine, Mary F., Peck, Carl C., Ramamoorthy, Anuradha, Rodrigues, A. David, Rowland, Malcolm, Sahajwalla, Chandrahas G., Sahre, Martina Dagmar, Schuck, Robert N., Sharma, Khushboo, Sissung, Tristan, Stika, Catherine S., Takimoto, Chris H., Tomkinson, Helen, Uetrecht, Jack, Vicini, Paolo, Vo, Karen D., Wagner, John A., Wang, Yaning, Wang, Yow-Ming C., Wells, Peter G., Wick, Michael J., Yee, Sook Wah, Yin, Ophelia, Zgheib, Nathalie K., Zhang, Lei, Zhu, Hao

Publikováno v: In Atkinson's Principles of Clinical Pharmacology Edition: Fourth Edition. 2022:xvii-xx