Radiopharmaceutical Drug Development Services

Radiopharmaceuticals Radiopharmaceutical Drug Development Services As one of the earliest CROs in China engaged in radiopharmaceutical research, InnoStar offers end-to-end non-clinical development services for both diagnostic and therapeutic radiopharmaceuticals. Our comprehensive capabilities span non-radioactive precursor studies, radioactive compound evaluations, and full non-clinical pharmacology, pharmacokinetics, safety assessment, and clinical bioanalysis. Certified with Class B radioactive site qualifications and authorization for the use of 37 isotopes, InnoStar is equipped with GLP/GCP-compliant facilities and a seasoned team of radiopharmaceutical experts to support high-quality, regulatory-ready development. InnoStar Radiopharmaceutical Development Platform Non-Clinical Pharmacodynamic Studies -In vitro studies: cellular uptake, endocytosis, and cytotoxicity -In vivo evaluation: PET/SPECT imaging, tumor targeting, and anti-tumor efficacy studies Non-Clinical Pharmacokinetic Studies -Absorption and tissue distribution profiling -Drug-drug interaction assessments -Metabolite identification and material balance studies -Human radiation dosimetry prediction using OLINDA software -Comprehensive PK characterization Non-Clinical Safety Evaluation -Single and multiple-dose toxicity studies -Delayed-release radiation toxicity assessments -Formulation safety evaluations -Designed to fully support IND submissions Clinical Bioanalysis -Development and validation of analytical methods for radiopharmaceuticals -Quantification of total radioactivity -Metabolite profiling in clinical samples Core Advantages of InnoStar's Radiopharmaceutical Platform Accreditations & Compliance •Class B radioactive facility certification •Authorized to use 37 radioisotopes •Fully compliant with GLP/GCP, supporting global regulatory standards (NMPA, FDA, OECD) Advanced Facilities •650 m² radioactive animal research space •550 m² dedicated lab for radiopharmaceutical R&D •Small-animal PET/MR imaging systems for real-time biodistribution and efficacy studies Robust Technical Platform •Specialized hot cells and isotope labeling systems •Capable of handling a wide range of isotopes: ⁶⁸Ga, ¹⁷⁷Lu, ²²⁵Ac, ⁸⁹Zr, and more •Radiochemical purity analysis and metabolic product spectrum evaluation Project Experience •30+ IND packages completed •20+ IND approvals for radiopharmaceuticals •4 dual filings approved in both China and the U.S. Flexible Collaboration & Global Standards Customized Services •Tailored study design and execution from early discovery through IND submission •Support for diagnostic and therapeutic applications Regulatory Alignment •Alignment with NMPA, FDA, and OECD standards •Capable of supporting global, multi-regional IND applications Partner with InnoStar for your radiopharmaceutical program and accelerate your path from discovery to approval with confidence. Copyright © 2017-2021©Shanghai InnoStar Bio-tech Co., Ltd. All Rights Reserved. Created By VPABrand.com