Suchergebnisse - "Wang, Yow-Ming"

PubPharm (140)

61

Systematic Review of Device Parameters and Design of Studies Bridging Biologic-Device Combination Products Using Prefilled Syringes and Autoinjectors

enthalten in: AAPS PharmSci | 2020

von Hu, P. | Wang, J. | Florian, J. | +7

62

Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies

enthalten in: Clinical pharmacology and therapeutics | 2020

von Li, J. | Florian, J. | Campbell, E. | +17

63

Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies

enthalten in: Clinical Pharmacology & Therapeutics | 2020

von Li, J. | Florian, J. | Campbell, E. | +17

64

Immunogenicity in Clinical Practice and Drug Development : When is it Significant?

enthalten in: Clinical and Translational Science | 2020

von Shakhnovich, V. | Meibohm, B. | Rosenberg, A. | +7

65

2019 White Paper on Recent Issues in Bioanalysis : FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 - Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

enthalten in: Bioanalysis | 2019

von Piccoli, S. | Mehta, D. | Vitaliti, A. | +72

66

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

67

Monoclonal Antibodies and Fc-Fusion Proteins for Pediatric Use : Dosing, Immunogenicity, and Modeling and Simulation in Data Submitted to the US Food and Drug Administration

enthalten in: Journal of clinical pharmacology | 2019

von Liu, X. | Dallmann, A. | Wang, Y. | +8

68

Effect of Body Weight on Risk-Benefit and Dosing Regimen Recommendation of Secukinumab for the Treatment of Moderate to Severe Plaque Psoriasis

enthalten in: Clinical pharmacology and therapeutics | 2019

von Lee, J. | Wang, J. | Florian, J. | +4

69

Use of pharmacodynamic/response biomarkers for therapeutic biologics regulatory submissions

enthalten in: Biomarkers in medicine | 2019

von Wang, Y. | Strauss, D. | Huang, S.

70

Considerations for Biologic Product Drug-Drug Interactions : A Regulatory Perspective

enthalten in: Clinical pharmacology and therapeutics | 2019

von Schrieber, S. | Pfuma-Fletcher, E. | Wang, X. | +5