A well-conceived and executed preclinical and clinical radiolabelled ADME program will provide you with a detailed assessment of the total fate (mass balance, route and rate of excretion, tissue distribution, metabolic pathways, and identity and quantity of metabolites) of your drug candidate to support regulatory submissions.
PRECLINICAL RADIOLABELLED ADME STUDIES
- Mass Balance/Routes of Excretion
- Placental/Milk Transfer
- Quantitative Whole-Body Autoradiography (QWBA)
- Microautoradiography (MARG)
- Plasma Protein Binding; RBC/Plasma Distribution
- Assessment of Covalent Binding
- in vitro Species Comparison of Metabolism
- Metabolic Reaction Phenotyping
- Metabolite Profiling, Identification, & Radioactivity Quantification
HUMAN RADIOLABELLED ADME STUDIES
- Consultation and Preparation of Clinical Study Protocol; including determination of human radiation dosimetry estimates on the basis of recommendations by MIRD, ICRP, and/or the Sponsor.
- Ethics Committee & Competent Authority Submission.
- Preparation and Release of Radiolabeled IMP According to GMP Annex 13 by a Licensed Radiopharmacy; including homogeneity and assessment of radiopurity of the IMP in formulation by HPLC-radio flow-through detection prior to dispensing.
- Drug Administration of Radiolabeled IMP by a Designated and Nuclear Medicine Physician.
- Flawless Execution of Study According to Protocol.
- Collection, Processing, and Analysis of Radioactive Human Blood, Plasma, and Excreta (urine, feces, and expired air).
- Metabolite Profiling, Identification, & Radioactivity Quantification.
- Preparation and Submission of an Integrated Clinical Study Report (CSR).
QPS IS A TRUE TURNKEY ADME STUDY PROVIDER WILL EFFECTIVELY EXECUTES YOUR RADIOLABELLED STUDIES
- By placing your studies with QPS, you will benefit from peer-to-peer communication with our expert ADME scientists, who have extensive industry and CRO experience, enabling optimal planning and execution of your studies.
- A senior technical professional will be assigned to facilitate the rapid progress of your drug candidate by shepherding the compound through the various preclinical studies to clinical ADME studies.
- Any compound specific and/or sample handling procedures will be seamlessly transferred between QPS preclinical and clinical teams to minimize delays at the different stages of drug development, which ensures rapid generation and rigorous analysis of preclinical and clinical ADME data, resulting in high-quality study reports ready for regulatory filing.