Santos GML - Search Results

1

Dealing with nanosafety around the globe-Regulation vs. innovation.

Wacker MG, Proykova A, Santos GML. Wacker MG, et al. Among authors: santos gml. Int J Pharm. 2016 Jul 25;509(1-2):95-106. doi: 10.1016/j.ijpharm.2016.05.015. Epub 2016 May 13. Int J Pharm. 2016. PMID: 27184102 Review.

2

A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013-2016.

Patel P, Cerqueira DM, Santos GML, de Lima Soares R, Sousa VD, Liberti L, McAuslane N. Patel P, et al. Among authors: santos gml. Ther Innov Regul Sci. 2020 Nov;54(6):1428-1435. doi: 10.1007/s43441-020-00169-5. Epub 2020 Jun 9. Ther Innov Regul Sci. 2020. PMID: 32519282 Free PMC article.

3

[Authorization for off-label use may not be beneficial for the Brazilian Unified National Health System].

Caetano R, Lopes LC, Santos GML, Osorio-de-Castro CGS. Caetano R, et al. Among authors: santos gml. Cad Saude Publica. 2023 Jun 26;39(6):e00085423. doi: 10.1590/0102-311XPT085423. eCollection 2023. Cad Saude Publica. 2023. PMID: 37377299 Free PMC article. Portuguese. No abstract available.

4

Incorporation and use of medicines in the Brazilian Unified National Health System: changes and risks of new Ministry of Health legislation.

Caetano R, Lopes LC, Santos GML, Osorio-de-Castro CGS. Caetano R, et al. Among authors: santos gml. Cad Saude Publica. 2023 Feb 17;39(2):e00148222. doi: 10.1590/0102-311XPT148222. eCollection 2023. Cad Saude Publica. 2023. PMID: 36820727 Free article. English, Portuguese. No abstract available.

5

Role of Physiologically Based Biopharmaceutics Modeling (PBBM) in Fed Bioequivalence Study Waivers: Regulatory Outlook, Case Studies and Future Perspectives.

Kollipara S, Martins FS, Sanghavi M, Santos GML, Saini A, Ahmed T. Kollipara S, et al. Among authors: santos gml. J Pharm Sci. 2024 Feb;113(2):345-358. doi: 10.1016/j.xphs.2023.11.030. Epub 2023 Dec 1. J Pharm Sci. 2024. PMID: 38043684 Review.

6

The role of a genetically stable, novel oral type 2 poliovirus vaccine in the poliomyelitis endgame.

Costa Clemens SA, Santos GML, Gonzalez I, Clemens R. Costa Clemens SA, et al. Among authors: santos gml. Rev Panam Salud Publica. 2023 Jul 3;47:e99. doi: 10.26633/RPSP.2023.99. eCollection 2023. Rev Panam Salud Publica. 2023. PMID: 37405121 Free PMC article.

7

Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities.

Rahalkar H, Sheppard A, Santos GML, Dasgupta C, Perez-Tapia SM, Lopez-Morales CA, Salek S. Rahalkar H, et al. Among authors: santos gml. Front Med (Lausanne). 2021 Sep 9;8:726660. doi: 10.3389/fmed.2021.726660. eCollection 2021. Front Med (Lausanne). 2021. PMID: 34568384 Free PMC article.

8

Project Orbis: Global Collaborative Review Program.

de Claro RA, Spillman D, Hotaki LT, Shum M, Mouawad LS, Santos GML, Robinson K, Hunt M, Healy C, Chan A, Looi YH, Rodrigues C, Rohr UP, Walther C, Pazdur R. de Claro RA, et al. Among authors: santos gml. Clin Cancer Res. 2020 Dec 15;26(24):6412-6416. doi: 10.1158/1078-0432.CCR-20-3292. Epub 2020 Oct 9. Clin Cancer Res. 2020. PMID: 33037016

9

Population pharmacokinetics of orally administrated bromopride: Focus on the absorption process.

Lachi-Silva L, Barth AB, Santos GML, Ahamadi M, Bruschi ML, Kimura E, de Araújo BV, Diniz A. Lachi-Silva L, et al. Among authors: santos gml. Eur J Pharm Sci. 2020 Jan 15;142:105081. doi: 10.1016/j.ejps.2019.105081. Epub 2019 Oct 25. Eur J Pharm Sci. 2020. PMID: 31669384

10

Overview of Brazilian Requirements for Therapeutic Equivalence of Orally Inhaled and Nasal Drug Products.

Silva MC, Costa HS, Valadares BN, Grecchi L, Nagao L, Santos GML. Silva MC, et al. Among authors: santos gml. AAPS PharmSciTech. 2019 Jun 24;20(6):235. doi: 10.1208/s12249-019-1415-y. AAPS PharmSciTech. 2019. PMID: 31236849

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