Found: 15
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Safety outcomes when switching between biosimilars and reference biologics: A systematic review and meta-analysis.
- Published in:
- PLoS ONE, 2023, v. 18, n. 10, p. 1, doi. 10.1371/journal.pone.0292231
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- Publication type:
- Article
The ELISA Detectability and Potency of Pegfilgrastim Decrease in Physiological Conditions: Key Roles for Aggregation and Individual Variability.
- Published in:
- Scientific Reports, 2020, v. 10, n. 1, p. 1, doi. 10.1038/s41598-020-59346-z
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- Publication type:
- Article
Evaluation of Truncated AUC as an Alternative Measure to Assess Pharmacokinetic Comparability in Bridging Biologic–Device Using Prefilled Syringes and Autoinjectors.
- Published in:
- Journal of Clinical Pharmacology, 2023, v. 63, n. 12, p. 1417, doi. 10.1002/jcph.2322
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- Publication type:
- Article
Impact of Switching on Pharmacokinetics of Therapeutic Biologics and Interchangeability Assessment—A Simulation Study.
- Published in:
- Journal of Clinical Pharmacology, 2022, v. 62, n. 1, p. 36, doi. 10.1002/jcph.1954
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- Publication type:
- Article
Comparability Considerations and Challenges for Expedited Development Programs for Biological Products.
- Published in:
- Drugs in R&D, 2020, v. 20, n. 4, p. 301, doi. 10.1007/s40268-020-00321-4
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- Article
Update on Therapeutic Protein-Drug Interaction: Information in Labeling.
- Published in:
- 2020
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- Publication type:
- journal article
Pharmacodynamic Biomarkers for Biosimilar Development and Approval: A Workshop Summary.
- Published in:
- Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 5, p. 1030, doi. 10.1002/cpt.2795
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- Publication type:
- Article
Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (III) A Randomized Trial with Interferon Beta‐1a Products.
- Published in:
- Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 2, p. 339, doi. 10.1002/cpt.2784
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- Publication type:
- Article
Evaluating the Utility of Proteomics for the Identification of Circulating Pharmacodynamic Biomarkers of IFNβ‐1a Biologics.
- Published in:
- Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 1, p. 98, doi. 10.1002/cpt.2778
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- Publication type:
- Article
Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (I) A Randomized Trial with PCSK9 Inhibitors.
- Published in:
- Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 1, p. 71, doi. 10.1002/cpt.2769
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- Publication type:
- Article
Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development – (II) A Randomized Trial with IL‐5 Antagonists.
- Published in:
- Clinical Pharmacology & Therapeutics, 2023, v. 113, n. 1, p. 80, doi. 10.1002/cpt.2760
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- Publication type:
- Article
Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies.
- Published in:
- Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 1, p. 40, doi. 10.1002/cpt.1653
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- Publication type:
- Article
Considerations for Biologic Product Drug–Drug Interactions: A Regulatory Perspective.
- Published in:
- Clinical Pharmacology & Therapeutics, 2019, v. 105, n. 6, p. 1332, doi. 10.1002/cpt.1366
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- Publication type:
- Article
Quantitative Relationship Between AUEC of Absolute Neutrophil Count and Duration of Severe Neutropenia for G‐CSF in Breast Cancer Patients.
- Published in:
- Clinical Pharmacology & Therapeutics, 2018, v. 104, n. 4, p. 742, doi. 10.1002/cpt.991
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- Publication type:
- Article
Silymarin Ascending Multiple Oral Dosing Phase I Study in Noncirrhotic Patients With Chronic Hepatitis C.
- Published in:
- Journal of Clinical Pharmacology, 2010, v. 50, n. 4, p. 434
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- Publication type:
- Article