GMP & GLP Solutions

Non-clinical safety study of radiopharmaceuticals is to make overall evaluation of the potential toxicity of all components in the samples to be used in clinical trials and/or samples to be marketed, including toxicology, radiation safety, etc., and provide supporting data information for safety evaluation of final products.

As the safety evaluation of radiopharmaceuticals is a necessary procedure and an important step before new drugs enter the final clinical trial and final approval, the State Food and Drug Administration requires preclinical toxicology evaluation to determine the toxicological characteristics of new candidate drugs before the first human study. Therefore, United Well strictly abides by the requirements of Good Laboratory Practice in the safety evaluation of radiopharmaceuticals, ensuring that variables are minimized, and controlling and monitoring are carried out according to appropriate guidance and standard operating procedures (SOPs).

Major function

United Well radiopharmaceutical safety evaluation laboratory plays a very important role in the non-clinical safety evaluation of drugs. 

For pre-clinical candidates (PCC) or IND, GLP toxicology study can conduct a comprehensive drug safety evaluation.

For early compound study, early diagnosis test (EDT) can reduce the risks and costs related to preclinical safety assessment by detecting and eliminating potential toxic drug candidates as early as possible.

Animal house

Animal house refers to the place where experimental animals are bred, raised and tested, and it is a facility for the seed preservation, production, experiment and research of experimental animals.

General toxicology laboratory

The laboratory can provide customers with complete general toxicological test data according to the requirements of new drug declaration and registration, and the whole test process is completed in facilities that meet GLP requirements.

Radioactive animal laboratory

More than ten kinds of nuclides such as ¹⁸F、¹⁴C、¹³¹I and ⁸⁹Zr can be operated in the laboratory. The platform can provide services such as pharmacodynamic and pharmacokinetic tests, radionuclide labeling and imaging experiments of common drugs/radiopharmaceuticals for innovative drug R&D and production units.

Radioactive protection and radiation monitoring

Safety pharmacology test

United Well carries out research on radiopharmaceuticals' safety pharmacology by referring to ICH guidelines, Guiding Principles for Pharmacological Tests of Human Drugs (S7A) and Guiding Principles for Non-clinical Evaluation of Potential Effects of Delayed Ventricular Repolarization (QT Interval Prolongation) of Human Drugs (S7B).

Carcinogenicity test

Radiopharmaceuticals generally do not need to be tested for carcinogenicity. However, if the non-radioactive components of radiopharmaceuticals are new structural compounds, we will refer to the relevant guiding principles of carcinogenicity test for carcinogenicity evaluation.

Single dose toxicity test

When it is necessary to carry out a single dose toxicity test in combination with the proposed clinical route, and detect radiation-sensitive indicators (such as hematology, bone marrow, reproductive organs, etc.), we will consider increasing the detection frequency and prolonging the observation period based on the characteristics of the tested substance, especially indicating the corresponding mass dose and radioactive dose for the administered dose.

Repeat dose toxicity test

In reference to the requirements of ICH M3(R2), two animal species are used in the trial, one being rodent and the other being non-rodent. When radiopharmaceuticals remain in the body for a long time, the observation period of toxicological tests will be correspondingly prolonged.

Genetic toxicity test

As radionuclides have the potential to cause damage to the genetic material of organisms, United Well will carefully consider its risk factors and make a scientific assessment on the genotoxicity risk of radiopharmaceuticals. If the non-radioactive components of radiopharmaceuticals are new structural compounds, genotoxicity of the non-radioactive components also needs to be evaluated.

Reproductive toxicity test

As the radionuclides carried by radiopharmaceuticals will produce radiation, United Well will scientifically evaluate the reproductive toxicity risk of radiopharmaceuticals based on the years of scientific research experience, and list the information related to the reproductive toxicity risk assessment to prompt risks for clinical use.

Other safety tests

For the samples to be used in clinical trials and/or the samples to be marketed, United Well will test the hemolysis, irritation and allergy of the radiopharmaceuticals, and our excellent experimenters will design the trial on the scientific basis by referring to the proposed clinical use.