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臨床試驗受託機構

明生生物科技股份有限公司 Mithra Biotechnology Inc.

卓越成果

全方位藥品試驗服務

Bioanalytical

Animal and Human Bioanalytical Services
LC-MS/MS Bioanalytical Method Development and Validation
ICP-MS Elemental Analysis Method Development and Validation
ELISA Method Development and Validation
BA/BE/PK/PD Studies
Biopharmaceuticals

Full Structural Characterization
Physicochemical Properties
Determination of Impurities
Production Optimization
Comparability Studies
QC release testing
Biosimilarity Studies
Pre-Clinical and Clinical Trials

Phase I-IV Studies
Listing Trials
Registration services:
BSE (Bridging Study Evaluation)

IND (Investigation New Drug)
NDA (New Drug Application)
Project Management
Clinical Monitoring
Data Management
Biostatistical Analysis

 

專長服務項目

  • Bioanalytical
  • Biopharmaceuticals
  • Pre-Clinical and Clinical Trials

提供實驗室服務

國際認證

 

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