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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 JE, García-Arieta A, Santos GML, Crane C, Rodrigues C, Simon C, Kim JM, Park SA, Okada Y, Kuribayashi R, Pfäffli C, Nolting A, Lojero IOC, Martínez ZR, Hung WY, Braddy AC, Leal NA, Triana DG, Clarke M, Bachmann P. Van Oudtshoorn JE, et al. Among authors: nolting a. J Pharm Pharm Sci. 2018;21(1):27-37. doi: 10.18433/J3X93K. J Pharm Pharm Sci. 2018. PMID: 29382433 Free article. Review.
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 Arieta A, Simon C, Lima Santos GM, Calderón Lojero IO, Rodríguez Martínez Z, Rodrigues C, Park SA, Kim JM, Kuribayashi R, Okada Y, Nolting A, Pfäffli C, Hung WY, Crane C, Braddy AC, Van Oudtshoorn J, Gutierrez Triana D, Clarke M. Garcia Arieta A, et al. Among authors: nolting a. J Pharm Pharm Sci. 2019;22(1):28-36. doi: 10.18433/jpps30215. J Pharm Pharm Sci. 2019. PMID: 30599818 Free article.
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 GML, Fernandes EAF, Simon C, Tam A, Triana DG, Potthast H, Kuribayashi R, Okada Y, Myoenzono A, Calderon IO, Rodriguez Z, Jones B, Park SA, Eum SY, Rodrigues C, Van Oudsthoorn J, Nolting A, Walther C, Roost MS, Hung WY, Braddy AC, Garcia-Arieta A. Crane C, et al. Among authors: nolting a. J Pharm Pharm Sci. 2019;22(1):486-500. doi: 10.18433/jpps30724. J Pharm Pharm Sci. 2019. PMID: 33760728 Free article.
Improvements in quality of life over 2 years with cladribine tablets in people with relapsing multiple sclerosis: The CLARIFY-MS study.
Brochet B, Solari A, Lechner-Scott J, Piehl F, Langdon D, Hupperts R, Selmaj K, Patti F, Brieva L, Maida EM, Alexandri N, Smyk A, Nolting A, Keller B, Montalban X, Kubala Havrdova E. Brochet B, et al. Among authors: nolting a. Mult Scler. 2023 Dec;29(14):1808-1818. doi: 10.1177/13524585231205962. Epub 2023 Nov 18. Mult Scler. 2023. PMID: 37978852 Free PMC article.
Treatment satisfaction, safety, and tolerability of cladribine tablets in patients with highly active relapsing multiple sclerosis: CLARIFY-MS study 6-month interim analysis.
Brochet B, Hupperts R, Langdon D, Solari A, Piehl F, Lechner-Scott J, Montalban X, Selmaj K, Valis M, Rejdak K, Havrdova EK, Patti F, Alexandri N, Nolting A, Keller B. Brochet B, et al. Among authors: nolting a. Mult Scler Relat Disord. 2022 Jan;57:103385. doi: 10.1016/j.msard.2021.103385. Epub 2021 Nov 9. Mult Scler Relat Disord. 2022. PMID: 35158476 Free article. Clinical Trial.
Development of ProTx-II Analogues as Highly Selective Peptide Blockers of Nav1.7 for the Treatment of Pain.
Adams GL, Pall PS, Grauer SM, Zhou X, Ballard JE, Vavrek M, Kraus RL, Morissette P, Li N, Colarusso S, Bianchi E, Palani A, Klein R, John CT, Wang D, Tudor M, Nolting AF, Biba M, Nowak T, Makarov AA, Reibarkh M, Buevich AV, Zhong W, Regalado EL, Wang X, Gao Q, Shahripour A, Zhu Y, de Simone D, Frattarelli T, Pasquini NM, Magotti P, Iaccarino R, Li Y, Solly K, Lee KJ, Wang W, Chen F, Zeng H, Wang J, Regan H, Amin RP, Regan CP, Burgey CS, Henze DA, Sun C, Tellers DM. Adams GL, et al. Among authors: nolting af. J Med Chem. 2022 Jan 13;65(1):485-496. doi: 10.1021/acs.jmedchem.1c01570. Epub 2021 Dec 21. J Med Chem. 2022. PMID: 34931831
72 results