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PubPharm (234)
61
Physiologically Based Pharmacokinetic Modeling in Regulatory Science : An Update From the U.S. Food and Drug Administration's Office of Clinical Pharmacology
enthalten in:
Journal of pharmaceutical sciences
| 2019
von
Grimstein, M.
|
Yang, Y.
|
Zhang, X.
| +4
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62
Role of Modeling and Simulation in the Development of Novel and Biosimilar Therapeutic Proteins
enthalten in:
Journal of pharmaceutical sciences
| 2019
von
Wang, Y.
|
Wang, Y.
|
Schrieber, S.
| +5
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63
A Holistic and Integrative Approach for Advancing Model-Informed Drug Development
enthalten in:
CPT: pharmacometrics & systems pharmacology
| 2019
von
Madabushi, R.
|
Wang, Y.
|
Zineh, I.
CommentOn: CPT Pharmacometrics Syst Pharmacol. 2019 Jan;8(1):5-8. - PMID 30370642
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64
Model‐Informed Drug Development : Current US Regulatory Practice and Future Considerations
enthalten in:
Clinical Pharmacology & Therapeutics
| 2019
von
Wang, Y.
|
Zhu, H.
|
Madabushi, R.
| +3
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65
Proceedings of a Workshop : US Food and Drug Administration‐International Society of Pharmacometrics Model‐Informed Drug Development in Oncology
enthalten in:
Clinical Pharmacology & Therapeutics
| 2019
von
Bruno, R.
|
Jin, J.
|
Maxfield, K.
| +5
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66
The US Food and Drug Administration's Model‐Informed Drug Development Paired Meeting Pilot Program : Early Experience and Impact
enthalten in:
Clinical Pharmacology & Therapeutics
| 2019
von
Madabushi, R.
|
Benjamin, J.
|
Grewal, R.
| +5
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67
Model‐Informed Drug Development : A Regulatory Perspective on Progress
enthalten in:
Clinical Pharmacology & Therapeutics
| 2019
von
Zhu, H.
|
Huang, S.
|
Madabushi, R.
| +3
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68
An Overview of Genomic Biomarker Use in Cardiovascular Disease Clinical Trials
enthalten in:
Clinical Pharmacology & Therapeutics
| 2019
von
Adeniyi, O.
|
Ramamoorthy, A.
|
Schuck, R.
| +4
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69
Use of Titration as a Therapeutic Individualization Strategy : An Analysis of Food and Drug Administration–Approved Drugs
enthalten in:
Clinical and Translational Science
| 2019
von
Schuck, R.
|
Pacanowski, M.
|
Kim, S.
| +2
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70
Quantitative Systems Pharmacology : A Regulatory Perspective on Translation
enthalten in:
CPT: Pharmacometrics & Systems Pharmacology
| 2019
von
Zineh, I.
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6
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