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PubPharm (234)
31
A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response‐Guided Titration
enthalten in:
Clinical Pharmacology & Therapeutics
| 2021
von
Wang, L.
|
Maxfield, K.
|
Guinn, D.
| +3
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32
Elucidating the Impact of Immunogenicity Assessment Postapproval : A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments
enthalten in:
Clinical Pharmacology & Therapeutics
| 2021
von
Guinn, D.
|
Madabushi, R.
|
Wang, Y.
| +2
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33
Evaluating Patients With Impaired Renal Function During Drug Development : Highlights From the 2019 US FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting
enthalten in:
Clinical Pharmacology & Therapeutics
| 2021
von
Sahre, M.
|
Milligan, L.
|
Madabushi, R.
| +9
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34
Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making—A workshop summary
enthalten in:
CPT: Pharmacometrics & Systems Pharmacology
| 2021
von
Jean, D.
|
Naik, K.
|
Milligan, L.
| +18
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35
Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling : A Systematic Evaluation
enthalten in:
Therapeutic innovation & regulatory science
| 2020
von
Guinn, D.
|
Madabushi, R.
|
Wang, Y.
| +3
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36
Role of Guidance and Policy in Enhancing the Impact of Clinical Pharmacology in Drug Development, Regulation, and Use
enthalten in:
Clinical pharmacology and therapeutics
| 2020
von
Madabushi, R.
|
Pfuma Fletcher, E.
|
Florian, J.
| +9
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37
Extrapolation of Adult Efficacy to Pediatric Patients With Chemotherapy-Induced Nausea and Vomiting
enthalten in:
Journal of clinical pharmacology
| 2020
von
Momper, J.
|
Heinrichs, M.
|
Krudys, K.
| +14
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38
Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic Evaluation
enthalten in:
Therapeutic innovation & regulatory science
| 2020
von
Guinn, D.
|
Madabushi, R.
|
Wang, Y.
| +3
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39
Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic Evaluation
enthalten in:
Therapeutic innovation & regulatory science
| 2020
von
Guinn, D.
|
Madabushi, R.
|
Wang, Y.
| +3
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40
Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic Evaluation
enthalten in:
Therapeutic innovation & regulatory science
| 2020
von
Guinn, D.
|
Madabushi, R.
|
Wang, Y.
| +3
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