Detalhe da pesquisa
1.
Biopharmaceutics classification system-based biowaivers for generic oncology drug products: case studies.
AAPS PharmSciTech
; 16(1): 5-9, 2015 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-25245330
2.
Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report.
CPT Pharmacometrics Syst Pharmacol
; 12(5): 610-618, 2023 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-36597353
3.
The effect of food vehicles on in vitro performance of pantoprazole sodium delayed release sprinkle formulation.
Int J Pharm
; 635: 122737, 2023 Mar 25.
Artigo
em Inglês
| MEDLINE | ID: mdl-36801362
4.
Use of Partial Area Under the Curve in Bioavailability or Bioequivalence Assessments: A Regulatory Perspective.
Clin Pharmacol Ther
; 110(4): 880-887, 2021 10.
Artigo
em Inglês
| MEDLINE | ID: mdl-33492710
5.
The global bioequivalence harmonisation initiative: Report of EUFEPS/AAPS third conference.
Eur J Pharm Sci
; 151: 105383, 2020 Aug 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-32473200
6.
2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity).
Bioanalysis
; 11(23): 2099-2132, 2019 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-31833782
7.
2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).
Bioanalysis
; 9(23): 1895-1912, 2017 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-29205053
8.
2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines 'Scientific'? (Part 1 - LCMS: small molecules, peptides and small molecule biomarkers).
Bioanalysis
; 9(22): 1807-1825, 2017 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-29148835
9.
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies).
Bioanalysis
; 8(23): 2457-2474, 2016 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-27855509
10.
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).
Bioanalysis
; 8(22): 2363-2378, 2016 Nov.
Artigo
em Inglês
| MEDLINE | ID: mdl-27712081
11.
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies).
Bioanalysis
; 7(23): 3019-34, 2015 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-26627049
12.
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 - small molecules by LCMS).
Bioanalysis
; 7(22): 2913-25, 2015.
Artigo
em Inglês
| MEDLINE | ID: mdl-26573485
13.
2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3--LBA, biomarkers and immunogenicity).
Bioanalysis
; 7(24): 3107-24, 2015 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-26635247
14.
Binding of polychlorinated biphenyls/metabolites to hemoglobin.
Toxicol Lett
; 142(1-2): 53-60, 2003 Apr 30.
Artigo
em Inglês
| MEDLINE | ID: mdl-12765239
15.
Polychlorinated biphenyls are not substrates for the multidrug resistance transporter-1.
Toxicol Appl Pharmacol
; 187(3): 168-77, 2003 Mar 15.
Artigo
em Inglês
| MEDLINE | ID: mdl-12662900
16.
Glucuronidation of hydroxylated polychlorinated biphenyls (PCBs).
Chem Res Toxicol
; 15(10): 1259-66, 2002 Oct.
Artigo
em Inglês
| MEDLINE | ID: mdl-12387623