RESEARCH

https://cpt.snu.ac.kr/en/Research/ResearchArea/NewDrugDevelopment/Developmentconsultation URL COPY
Consultation on the clinical development of new drug
  • Pre-clinical research results consultation

- Toxicology research results consultation

- Pre-clinical research of pharmacokinetics/efficacy results consultation

- Early clinical research strategy consultation

  • Clinical research consultation

- Consultation of domestic and international clinical development strategy (e.g., Pre-investigational New Drug meeting)

- Protocol development and consultation

- Consultation on adherence to the clinical trial strategy and drug licensing regulations & guidelines

  • Clinical research results consultation

- Clinical research results consultation

- English translation of clinical study report (CSR) and CSR consultation

- Consultation of the follow-up clinical development strategy

Government research & development project support and consultation
  • Consultation of the clinical research design and performance for special patient population
  • Consultation regarding safety evaluation for post-marketing drugs and exploring predictive biomarker, and developing dose adjustment algorithms, etc.
  • Consultation of planning and conducting clinical research to assess pharmacokinetic/pharmacodynamic differences between different ethnic groups.
  • Development and consultation of drug-related guidelines