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PubPharm (25)
1
2019 White Paper On Recent Issues in Bioanalysis : FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (
enthalten in:
Bioanalysis
| 2019
von
Booth, B.
|
Stevenson, L.
|
Pillutla, R.
| +50
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2
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline
enthalten in:
Bioanalysis
| 2019
von
Nehls, C.
|
Buonarati, M.
|
Cape, S.
| +62
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3
Contract research organization commentary on the importance of harmonization and the impact of ICH M10
enthalten in:
Bioanalysis
| 2019
von
Briscoe, C.
|
Nehls, C.
|
Buonarati, M.
| +4
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4
12th GCC Closed Forum : critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity
enthalten in:
Bioanalysis
| 2019
von
Briscoe, C.
|
Hughes, N.
|
Hayes, R.
| +59
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5
Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis
enthalten in:
Bioanalysis
| 2019
von
Islam, R.
|
Kar, S.
|
Ritzén, H.
| +60
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6
Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis
enthalten in:
Bioanalysis
| 2019
von
Islam, R.
|
Kar, S.
|
Ritzén, H.
| +60
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7
12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity
enthalten in:
Bioanalysis
| 2019
von
Briscoe, C.
|
Hughes, N.
|
Hayes, R.
| +59
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8
Contract research organization commentary on the importance of harmonization and the impact of ICH M10
enthalten in:
Bioanalysis
| 2019
von
Briscoe, C.
|
Nehls, C.
|
Buonarati, M.
| +4
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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)
enthalten in:
Bioanalysis
| 2019
von
Booth, B.
|
Stevenson, L.
|
Pillutla, R.
| +50
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10
11th GCC Closed Forum : cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation
enthalten in:
Bioanalysis
| 2018
von
Islam, R.
|
Briscoe, C.
|
Bower, J.
| +68
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