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            1. PK/PD Platform

              The GPT Non-Clinical Pharmacokinetics/Pharmacodynamics (PK/PD) Service Platform features a stable, well-qualified, and comprehensive service system that offers professional customized services. Leveraging a variety of technologies including ELISA, MSD, qPCR, ddPCR, flow cytometry, and LC-MS/MS, GPT has extensive experience in diverse PK/PD projects encompassing biological products (such as antibodies, fusion proteins, vaccines, cell and gene therapies), chemical medicine (including vitamins, minerals), and traditional Chinese medicines.


              Service Offering


              • Absorption distribution metabolism excretion (ADME)

              - Single/multiple administration pharmacokinetics

              - Bio-availability study

              - Bio-equivalence evaluation

              - Drug tissue distribution

              - Urine/Stool/Bile excretion test

              - Plasma protein binding rate

              - Drug metabolizing enzymes and transporters research

              - Material balance


              • Immunogenicity Analysis

              - Anti-drug antibody

              - Neutralizing antibody


              • Biomarker

              - Receptor occupation

              - Biomarker


              • Toxicology (non-GLP)

              - Toxicokinetics

              - Long-term toxicology

              - Acute toxicity


              Service Process


              圖片10.png


              Advantages 


              • Capability to Analyze Multiple Drugs

              Biological Product:

              - Antibody, Fusion protein, Vaccine, Cell and gene therapy, etc.

              Chemical Medicine:

              - Vitamins, Mineral drugs, etc.; Chinese medicine.


              • Highly Stable Technical System

              - %TE (Inter) < 25% (ICH requires less than 40%); 

              - %RE (Inter) ≤ ±13% (ICH requirements are within ± 25%); 

              - %CV (Inter) ≤ ±13% (ICH requirements are within ± 25%).


              • World’s leading mouse model repository

              - Single target/multi-target gene humanized mouse strain 800+;

              - Immune system humanized mouse strain 20+.

               

               Case Study


              Animal: BALB/c-hCD47/hSIRPα, Female

              ROA: i.v.

              Method: Indirect ELISA

              Lower limit of quantitation (LLOQ): 0.005 μg/mL

              Blood collection cycle: 672 Hours (Day28)


              Table 1. The accuracy and precision data of the standard and quality controls reflect the technical stability during method validation.


              Intra/Inter

              STD1

              STD2

              STD3

              STD4

              STD5

              STD6

              STD7

              QC1

              QC2

              QC3

              QC4

              QC5

              Intra1%RE

              2.3

              -2.6

              -7.0

              5.4

              6.0

              -4.8

              0.6

              -15.2

              -10.7

              -10.8

              0.1

              6.2

              Intra1%CV

              0.1

              11.0

              1.5

              1.8

              4.1

              1.6

              2.4

              8.4

              11.1

              2.3

              8.9

              3.2

              Intra2%RE

              0.3

              -1.6

              3.7

              -1.6

              -0.2

              0.5

              -0.3

              -20.7

              -13.9

              -19.7

              -5.3

              -3.2

              Intra2%CV

              2.6

              17.6

              1.3

              1.4

              5.1

              0.7

              5.7

              10.7

              10.6

              9.1

              8.1

              9.5

              Intra3%RE

              -0.8

              5.8

              -9.3

              9.7

              -6.2

              4.0

              -1.7

              -5.9

              -14.0

              -14.6

              4.6

              10.1

              Intra3%CV

              3.2

              2.0

              10.0

              2.4

              7.8

              3.3

              12.8

              7.3

              4.5

              5.6

              1.5

              5.6

              Intra4%RE

              -3.1

              -3.8

              -4.7

              -4.4

              16.3

              1.6

              -8.2

              -10.3

              -6.3

              -1.5

              4.5

              -5.0

              Intra4%CV

              11.2

              3.6

              8.2

              16.3

              6.4

              2.8

              2.4

              8.6

              5.8

              13.1

              10.6

              8.1

              Inter%RE

              -2.7

              1.7

              -2.3

              -0.8

              3.0

              1.9

              -3.1

              -11.6

              -13.1

              -12.2

              3.0

              -1.7

              Inter%CV

              5.5

              8.2

              6.8

              8.9

              9.8

              4.5

              6.1

              9.8

              9.1

              12.4

              8.0

              9.9

              Inter%TE

              8.2

              9.9

              9.2

              9.7

              12.8

              6.4

              9.2

              21.4

              22.1

              24.6

              10.9

              11.6 

               

               圖片11.png


              Figure 1. Drug Concentrations-Time Curve in BALB/c-hCD47/hSIRPα

               

               


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