Detalhe da pesquisa
1.
Remdesivir in COVID-19 Patients with Impaired Renal Function.
J Am Soc Nephrol
; 32(2): 518-519, 2021 Feb 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-36734842
2.
Influence of point estimates and study power of bioequivalence studies on establishing bioequivalence between generics by adjusted indirect comparisons.
Eur J Clin Pharmacol
; 71(9): 1083-9, 2015 Sep.
Artigo
em Inglês
| MEDLINE | ID: mdl-26105964
3.
Statistical approaches to indirectly compare bioequivalence between generics: a comparison of methodologies employing artemether/lumefantrine 20/120 mg tablets as prequalified by WHO.
Eur J Clin Pharmacol
; 68(12): 1611-8, 2012 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-23011014
4.
2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Bioanalysis
; 14(9): 505-580, 2022 May.
Artigo
em Inglês
| MEDLINE | ID: mdl-35578993
5.
2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome (Part 1 - Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos).
Bioanalysis
; 13(4): 203-238, 2021 Feb.
Artigo
em Inglês
| MEDLINE | ID: mdl-33470871
6.
2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback (Part 2A - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Bioanalysis
; 13(5): 295-361, 2021 Mar.
Artigo
em Inglês
| MEDLINE | ID: mdl-33511867
7.
Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications.
Clin Transl Sci
; 12(5): 490-496, 2019 09.
Artigo
em Inglês
| MEDLINE | ID: mdl-31046182
8.
Summary report of second EUFEPS/AAPS conference on global harmonization in bioequivalence.
Eur J Pharm Sci
; 127: 24-28, 2019 Jan 15.
Artigo
em Inglês
| MEDLINE | ID: mdl-30342171
9.
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
10.
Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.
Clin Pharmacol Ther
; 104(3): 539-545, 2018 09.
Artigo
em Inglês
| MEDLINE | ID: mdl-29319156
11.
The Global Bioequivalence Harmonization Initiative: Summary report for EUFEPS international conference.
Eur J Pharm Sci
; 111: 153-157, 2018 Jan 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-28964950
12.
2018 White Paper on Recent Issues in Bioanalysis: 'A global bioanalytical community perspective on last decade of incurred samples reanalysis (ISR)' (Part 1 - small molecule regulated bioanalysis, small molecule biomarkers, peptides & oligonucleotide bioanalysis).
Bioanalysis
; 10(22): 1781-1801, 2018 Nov 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-30488725
13.
2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity).
Bioanalysis
; 10(23): 1897-1917, 2018 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-30488729
14.
Interchangeability between first-line generic antiretroviral products prequalified by WHO using adjusted indirect comparisons.
Antivir Ther
; 22(2): 135-144, 2017.
Artigo
em Inglês
| MEDLINE | ID: mdl-27646863
15.
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
16.
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
17.
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
18.
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 - LBA, biomarkers and immunogenicity).
Bioanalysis
; 8(23): 2475-2496, 2016 Dec.
Artigo
em Inglês
| MEDLINE | ID: mdl-27855512
19.
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
20.
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