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PubPharm (39)
1
A Randomized, Double-Blind Study Comparing Pharmacokinetics and Pharmacodynamics of Proposed Biosimilar ABP 798 With Rituximab Reference Product in Subjects With Moderate to Severe Rheumatoid Arthritis
enthalten in:
Clinical pharmacology in drug development
| 2020
von
Burmester, G.
|
Chien, D.
|
Chow, V.
| +3
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2
Statistical Considerations on Clinical Efficacy Studies of Biosimilar for PMDA Submission
enthalten in:
Therapeutic innovation & regulatory science
| 2020
von
Asami, Y.
|
Pan, J.
|
Oh, M.
| +1
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3
A randomized, double-blind, single-dose, three-arm, parallel group study to determine pharmacokinetic similarity of ABP 959 and eculizumab (Soliris® ) in healthy male subjects
enthalten in:
European journal of haematology
| 2020
von
Chow, V.
|
Pan, J.
|
Chien, D.
| +2
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4
Bayesian design of biosimilars clinical programs involving multiple therapeutic indications
enthalten in:
Biometrics
| 2020
von
Psioda, M.
|
Hu, K.
|
Zhang, Y.
| +2
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5
Statistical Considerations on Clinical Efficacy Studies of Biosimilar for PMDA Submission
enthalten in:
Therapeutic innovation & regulatory science
| 2020
von
Asami, Y.
|
Pan, J.
|
Oh, M.
| +1
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6
Statistical Considerations on Clinical Efficacy Studies of Biosimilar for PMDA Submission
enthalten in:
Therapeutic innovation & regulatory science
| 2020
von
Asami, Y.
|
Pan, J.
|
Oh, M.
| +1
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7
Statistical Considerations on Clinical Efficacy Studies of Biosimilar for PMDA Submission
enthalten in:
Therapeutic innovation & regulatory science
| 2020
von
Asami, Y.
|
Pan, J.
|
Oh, M.
| +1
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8
Guest editors' note on special issue on real-world experience and randomized clinical trials
enthalten in:
Journal of biopharmaceutical statistics
| 2019
von
Pan, J.
|
Lin, D.
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9
Guest editors’ note on special issue on real-world experience and randomized clinical trials
enthalten in:
Journal of biopharmaceutical statistics
| 2019
von
Pan, J.
|
Lin, D.
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10
Improving the power to establish clinical similarity in a Phase 3 efficacy trial by incorporating prior evidence of analytical and pharmacokinetic similarity
enthalten in:
Journal of biopharmaceutical statistics
| 2018
von
Zeng, D.
|
Pan, J.
|
Hu, K.
| +2
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Sprache: Englisch
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6
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5
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