Detalles de la búsqueda
1.
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.
J Pharm Pharm Sci
; 22(1): 28-36, 2019.
Artículo
en Inglés
| MEDLINE | ID: mdl-30599818
2.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-35578993
3.
Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report.
J Pharm Sci
; 110(2): 594-609, 2021 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-33152375
4.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-33470871
5.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-31833782
6.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-30488725
7.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-30488729
8.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-29205053
9.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-29148835
10.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-27855509
11.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-27855512
12.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-27712081
13.
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.
Artículo
en Inglés
| MEDLINE | ID: mdl-26573485
14.
Internal Standards (IS) monitoring in CROs: Anvisa perspective.
Bioanalysis
; 11(18): 1653-1655, 2019 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-31623452
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