Analysis Services

GCLP: Good Clinical Laboratory Practice

A Good Clinical Laboratory Practice (GCLP) facility is an institution authorized by the Minister of Food and Drug Safety (MFDS) following rigorous site inspections and evaluations. It conducts clinical study sample analysis in compliance with strict regulatory requirements under the pharmaceutical affairs act and the regulations on the safety of pharmaceuticals.

APACE (Advanced Pharmacological Analysis for Clinical Excellence) is a GCLP-certified institution dedicated to advancing drug development and medical science to contribute to a healthier society. As a trusted clinical study sample analysis partner, we foster strong collaborations by delivering high-quality analytical services at reasonable costs while adhering to both domestic and international regulations and guidelines. Moving forward, we remain committed to expanding our analytical capabilities, driving continuous research and development, and providing valuable support for our clients' future innovations.

질량분석

Mass spectrometry analysis

LC-MS/MS bioanalysis

  • Method development

  • Method validation

  • Clinical study sample analysis

Optimization

Lead Optimization

  • Non-GLP Pre-toxicity

  • Method development

  • Sample analysis

약물스크리닝
핵산분석

Nucleic acids bioanalysis

Nucleic acids bioanalysis

  • SNP Genotyping

  • Method development

Mass spectrometry process

Good Clinical Laboratory Practice (GCLP)

Compliance with domestic and international guidelines

qa점검

01

Request of service

  • Issuance of quotation
  • Signing of contract

02

Analytical method development

  • Approval of analysis protocol
  • Initiation of analysis

03

Analytical method validation

  • Conducting analytical method validation for each verification category

04

Clinical study sample analysis

  • Conducting clinical study sample analysis using validated methods

05

Issuance of report

  • Issuance of final report upon completion of Analysis

06

Completion of service

  • Data storage and backup Sample storage and return

Initiation of analysis

Completion of analysis

Approval of
analysis protocol

오른쪽화살표

Analytical
method validation

오른쪽화살표

Clinical study
sample analysis

오른쪽화살표

Approval of
final report

Nucleic acids bioanalysis : SNP Genotyping

Genotyping identifies specific gene mutations or variations and is used in disease diagnosis,
prevention, personalized treatment, and drug response prediction.

Skilled genotype analysis

ABCB1, CYP2C9, CYP2C19, CYP3A4, CYP3A5, NQO1, SLC22A1, SLC22A3

WITHOUT PHARMACOGENOMICS

WITHOUT PHARMACOGENOMICS

WITH PHARMACOGENOMICS

WITH PHARMACOGENOMICS
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