EN
Supporting drug development and package insert drafting by analyzing the in vivo exposure-response relationship of drugs. Research contents include studies such as SAD/MAD, food effects, mass balance, drug interaction, and pharmacokinetics (PK) in specific populations. For example, determining the starting dose in first-in-human trials, selecting doses for expansion phase and recommended Phase 2 dose, as well as identifying intrinsic and extrinsic factors affecting the safety and efficacy of the investigational drug, thereby assisting in the rapid advancement of new drug development and enhancing the success rate.
Clinical Protocol Design: FIH dose selection and optimization, Phase I dose escalation trials, Phase II dose exploration, Phase III clinical risk/benefit prediction
PK Protocol Design: DDI, food effect, PK in specific populations, BE
Clinical Pharmacology Data Analysis (NCA): PK/PD analysis
PK/PD modeling
Population PK modeling (PopPK)
Dose/Exposure-Response Analysis (E-R)
Physiologically Based Pharmacokinetic (PBPK) modeling
Human PK/effective dose prediction
Cardiotoxicity clinical trial planning：Including TQT and C-QT studies and TQT clinical trial exemptions
Clinical pharmacology strategy design and consultation
Formulation of clinical pharmacology development plans
Clinical pharmacology consultation for U.S. regulatory submissions: Participation in pre-IND/pre-NDA/BLA meetings
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