Gustavo Mendes Lima Santos

Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India

Sau L. Lee, Bhawana Saluja, Alfredo García‐Arieta et al. · The AAPS Journal · 2015 · 67 citations

Pharmacy, Pharmaceutical Policy, Pharmacology +14

2016 White Paper on Recent Issues in Bioanalysis: Focus on Biomarker Assay Validation (BAV): (Part 3 – Lba, Biomarkers and Immunogenicity)

Susan Richards, Lakshmi Amaravadi, Renuka Pillutla et al. · Bioanalysis · 2016 · 59 citations · Full text

Pharmacy, Biomedical Sciences, Pharmacology +17

2015 White Paper on Recent Issues in Bioanalysis: Focus on New Technologies and Biomarkers (Part 2 – Hybrid LBA/LCMS and Input from Regulatory Agencies)

Brad Ackermann, Hendrik Neubert, Nicola Hughes et al. · Bioanalysis · 2015 · 55 citations · Full text

Pharmacy, Biomedical Sciences, Pharmaceutical Analysis +17

Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report

Amitava Mitra, Sandra Suarez‐Sharp, Xavier Pépin et al. · Journal of Pharmaceutical Sciences · 2020 · 54 citations

Pharmacy, Pharmacokinetics, Pharmacology +16

2016 White Paper on Recent Issues in Bioanalysis: Focus on Biomarker Assay Validation (BAV) (Part 1 – Small Molecules, Peptides and Small Molecule Biomarkers by LCMS)

Eric Yang, Jan Welink, Stephanie Cape et al. · Bioanalysis · 2016 · 48 citations · Full text

Pharmacy, Biochemistry, Biomedical Sciences +17