109 results on '"Welink, Jan"'
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2. How to Get Stuff Back?
3. The environmental impact of transport systems
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)
5. Influence of point estimates and study power of bioequivalence studies on establishing bioequivalence between generics by adjusted indirect comparisons
6. Economic viability of extracting high value metals from end of life vehicles
7. Low cost method of industrial symbiotic network on large amounts of residual materials
8. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 – hybrid LBA/LCMS, ELN & regulatory agencies’ input)
9. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1 – small molecules by LCMS)
10. Statistical approaches to indirectly compare bioequivalence between generics: a comparison of methodologies employing artemether/lumefantrine 20/120 mg tablets as prequalified by WHO
11. Bei welchen Bauteilen ist die Gewinnung hochwertiger Metalle aus Altautos wirtschaftlich?
12. Requirements for generic anti-epileptic medicines: a regulatory perspective
13. 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)
14. 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)
15. Remdesivir in COVID-19 Patients with Impaired Renal Function
16. 2013 White Paper on recent issues in bioanalysis: ‘hybrid’ – the best of LBA and LCMS
17. Een groene jas voor de orchidee : Perspectieven op duurzaam verpakken in de sierteelt
18. 2012 White Paper on Recent Issues in Bioanalysis and Alignment of Multiple Guidelines
19. Conference Report: US FDA/EMA harmonization of their bioanalytical guidance/guideline and activities of the Global Bioanalytical Consortium
20. 2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance
21. 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)
22. Overview of the European Medicines Agency's development of product-specific bioequivalence guidelines
23. Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications
24. Summary report of second EUFEPS/AAPS conference on global harmonization in bioequivalence
25. 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)
26. 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)
27. Interchangeability between first-line generic antiretroviral products prequalified by WHO using adjusted indirect comparisons
28. 2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 – LBA: immunogenicity, biomarkers and PK assays)
29. 2017 White Paper on recent issues in bioanalysis: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies’ inputs)
30. 2017 White Paper on recent issues in bioanalysis: aren't BMV guidance/guidelines ‘Scientific’? (Part 1 – LCMS: small molecules, peptides and small molecule biomarkers)
31. 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 3 – LBA, biomarkers and immunogenicity)
32. 2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 – Hybrid LBA/LCMS and input from regulatory agencies)
33. 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)
34. Assessment of the interchangeability between generics
35. Interchangeability between First-Line Generic Antiretroviral Products Prequalified by WHO using Adjusted Indirect Comparisons
36. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 – hybrid LBA/LCMS and input from regulatory agencies)
37. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 3 – LBA, biomarkers and immunogenicity)
38. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 1 – small molecules by LCMS)
39. Overview of the European Medicines Agency's Development of Product‐Specific Bioequivalence Guidelines.
40. Switching to generic anti-epileptic medicines: A regulatory perspective
41. CARBON DIOXIDE EMISSION ASSOCIATED WITH THE PRODUCTION OF PLASTICS - A COMPARISON OF PRODUCTION FROM CRUDE OIL AND RECYCLING FOR THE DUTCH CASE
42. Pharmacokinetics and pharmacodynamics of lobaplatin (D-19466) in patients with advanced solid tumors, including patients with impaired renal or liver function
43. Selection of the comparator product in the World Health Organisation Prequalification of Medicines Programme
44. A dose-finding and pharmacokinetic study of reversal of multidrug resistance with SDZ PSC 833 in combination with doxorubicin in patients with solid tumors
45. CARBON DIOXIDE EMISSION ASSOCIATED WITH THE PRODUCTION OF PLASTICS - A COMPARISON OF PRODUCTION FROM CRUDE OIL AND RECYCLING FOR THE DUTCH CASE
46. Quantification of BNP7787 (dimesna) and its metabolite mesna in human plasma and urine by high-performance liquid chromatography with electrochemical detection
47. Response to: "The Role of Quantitative Systems Pharmacology in the Design of First‐in‐Human Trials".
48. Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.
49. 2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).
50. Interchangeability between first-line generic antiretroviral products prequalified by WHO using adjusted indirect comparisons.
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