Therapeutic Area·DG Japan

Clinical Pharmacology

PK/PD modeling datasets, drug exposure metrics, dose-response, drug-drug interaction studies, and population PK analyses. Output supports dose justification at IND/NDA submissions.

Steward · Anatomy · systemic

Avg. quality

Assets

Total rows

533,497

Certified

/ 4

Source systems

Source systemsWatson LIMSPhoenix WinNonlinNONMEM 7.5

Common tagspk · 2pc · 1bioanalytical · 1nca · 1pp · 1popk · 1nonmem · 1modeling · 1

Assets

Asset

Type · Status

Rows

Quality

Updated

PK Plasma Concentrations
Confidential
pkpd_pc_concentrations
Plasma concentration vs. time profiles for all dosing cohorts. Bioanalytical results from validated LC-MS/MS assays at central bioanalytical lab.
TableApproved
412.9K
95
19d ago
NCA PK Parameters
Confidential
pkpd_pp_nca_summary
Per-subject AUC0-t, AUC0-inf, Cmax, Tmax, t1/2 derived from non-compartmental analysis in Phoenix WinNonlin 8.4.
TableApproved
28.2K
94
21d ago
PopPK Analysis Dataset (NONMEM)
Restricted
popk_nonmem_dataset
NONMEM-formatted population PK dataset for the COMPOUND-X program. Includes covariates (weight, age, eGFR, hepatic impairment).
Data SetApproved
92.4K
92
25d ago
Therapeutic Exposure Window
Internal
term_therapeutic_window
Definition of therapeutic exposure window for COMPOUND-X derived from PK/PD modeling and used for dose decisions.
Business TermApproved
—
100
5mo ago