Consulting Services

Overview of consulting services

큰따옴표

Contributing to Successful Drug Development

Providing end-to-end drug development consulting services to establish safe and effective dosing regimens
using clinical pharmacology methodologies and to design efficient clinical trials

큰따옴표

Preclinical data(PK, TK, Efficacy, etc)

  • Starting dose determination for First-In-Human studies
  • Overall study design and protocol development

Clinical trial(phase 1 to phase 3) data analysis

  • Characterization of drug pharmacokinetics and pharmacodynamics
  • Analysis of drug exposure-response relationships using
  • pharmacokinetic-pharmacodynamic modeling
  • Recommendation on optimal dosing regimens for patients

Pharmacokinetics-Pharmacodynamic analysis

  • Estimation of PK/PD parameters through non-compartmental analysis
  • PK/PD relationship analysis
  • Optimization of dosage and administration through dose-response analysis

Population PK/PD analysis

  • Early-phase clinical trial design
  • Designing early-phase clinical trials and establishing initial dosing regimens through preclinical data-driven modeling and simulation

Preclinical trial

Efficacy data
비임상시험
Toxicity data
비임상시험
오른쪽 화살표

apace 로고

PK/PD
Modeling & Simulation

비임상시험
오른쪽 화살표

Estimation of toxic/therapeutic dose range in humans

Designing early-phase clinical trials and establishing
initial dosing regimens

비임상시험
  • Late-phase clinical trial design
  • Optimizing late-phase clinical trial design and dosing strategy using clinical data-driven modeling and simulation

Preclinical trial

비임상시험

Clinical trial

임상시험
오른쪽 화살표

apace 로고

PK/PD
Modeling & Simulation

Modeling & Simulation
오른쪽 화살표

Late-phase clinical trial
design and optimization
of dosage and administration

후기 임상 시험 디자인 및 용량∙용법 최적화

Applicable throughout the entire new drug development cycle

신약개발전주기활용
오른쪽 화살표
  • Designing early-phase clinical
  • rials and determining dosage
  • and administration based on
  • preclinical data
오른쪽 화살표
  • Dose-response relationship analysis
  • Late-phase clinical trial design and
  • optimization of dosage and administration
오른쪽 화살표
  • Gathering additional
  • data on drug usage
  • Generating evidence to
  • support indication expansion
Contact us