公開日期 | 標題 | 作者 | 來源出版物 | WOS | 全文 |
2019 | The Requirements for Additional Strength Biowaivers for Immediate Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities | Crane, C.; Santos, G. M. L.; Fernandes, E. A. F.; Simon, C.; Tam, A.; Triana, D. G.; Potthast, H.; Kuribayashi, R.; Okada, Y.; Myoenzono, A.; Calderon, I. O.; Rodriguez, Z.; Ben, Jones; Park, S. A.; Eum, S. Y.; Rodrigues, C.; Van Oudsthoorn, J.; Nolting, A.; Walther, C.; Roost, M. S.; Wen-Yi Hung ; Braddy, A. C.; Garcia-Arieta, A. | Journal of Pharmacy and Pharmaceutical Sciences | | |
2018 | A Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the International Generic Drug Regulators Programme | van Oudtshoorn, J.; Garcia-Arieta, A.; Santos, G. M. L.; Crane, C.; Rodrigues, C.; Simon, C.; Kim, J. M.; Park, S. A.; Okada, Y.; Kuribayashi, R.; Pfaffli, C.; Nolting, A.; Lojero, I. O. C.; Martinez, Z. R.; Wen-Yi Hung ; Braddy, A. C.; Leal, N. A.; Triana, D. G.; Clarke, M.; Bachmann, P. | Journal of Pharmacy and Pharmaceutical Sciences | | |
2018 | A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme | Garcia-Arleta, A.; Simon, C.; Santos, G. M. L.; Lojero, I. O. C.; Martinez, Z. R.; Rodrigues, C.; Park, S. A.; Kim, J. M.; Kuribayashi, R.; Okada, Y.; Nolting, A.; Pfaffli, C.; Wen-Yi Hung ; Crane, C.; Braddy, A. C.; van Oudtshoorn, J.; Triana, D. G.; Clarke, M. | Journal of Pharmacy and Pharmaceutical Sciences | | |