FDA and NMPA Compliant DMPK Full Filing Study Compliant modified formulation submission studies Compliant formulation equivalency filing studies

3D BioOptima can provide a broad spectrum of PK studies of small/large molecules, peptides, antibody drug conjugates (ADC), and prodrugs

Four sequential events may occur following a drug orally administered to the body, including absorption, distribution, metabolism, and excretion (ADME), as illustrated in the above scheme. 3D BioOptima can provide mechanistic in-vivo ADME studies.

The declaration of new drugs to the clinic generally requires a suitable formulation, and a large number of comparative formulation studies are required in the clinic to confirm the suitable formulation. Preclinical animal experiments can dynamically evaluate the disintegration, absorption, distribution, metabolism and excretion processes of formulations in animals, bridging the relationship between in vitro dissolution and in vivo exposure.

In vitro and in vivo evaluation of the early screening phase of ADME studies Interpretation of in vitro and ex vivo data Pharmacogenetic evaluation and optimization

Using advanced instruments, 3D BioOptima offers comprehensive and FDA/CFDA GLP-compliant bioanalytical services to support preclinical and clinical development for small molecules, large molecules and biomarkers.

PBPK modeling and prediction of human PK Human first dose and PK prediction Human PKPD modeling and simulation studies

3D BioOptima offers a large panel of s.c. xenograft tumor models. Our experienced and professional scientific team will help our sponsors choose appropriate models for preclinical oncology studies.

3D BioOptima can perform exploratory (non-GLP) toxicity studies (rodent and non-rodent) for compounds in the stage of lead optimization.