Drug Safety Evaluation Center
The drug safety evaluation package research data provided by Medicilon puya was reported to CFDA, the US FDA, and the Australian TGA 15 times for Investigational New Drug (IND for short). , Australia TGA declared Investigational New Drug (IND) more than 60 times.
Drug Safety Evaluation
The main content of pharmacology and toxicology research
Single dose toxicity test (rodent and non-rodent)
Repeated dose toxicity test (rodent and non-rodent)
Safety pharmacological tests: central nervous system research, cardiovascular system (canine and monkey telemetry and non-telemetry technology), respiratory system
Reproductive toxicity test [Fertility and early embryo development toxicity test (reproduction stage I), embryo-fetal development toxicity test (reproduction stage II)
Local toxicity test (hemolysis, allergy, irritation test)
Drug safety evaluation content: such as general acute and chronic toxicity studies, histopathological studies, reproductive toxicity tests, genotoxicity studies, safety pharmacology studies, investigation studies, studies on toxicity and safety biomarkers, etc.
Medicilon puya Drug Safety Evaluation Qualification
Medicilon puya has fully passed the AAALAC certification in 2009, and again passed the AAALAC certification in 2012.
Medicilon puya has fully passed the CFDA GLP certification in 2011, and again passed the CFDA GLP certification in 2014. The toxicological research data of Medicilon puya is also in line with the GLP standards of the US FDA and OECD.
The animal room of Medicilon puya’s Drug Safety Evaluation Center has an area of more than 10,000 square meters and can accommodate animals:
Guinea pig: 400
Drug Safety Evaluation Index System
Article 43 of the “Quality Management Standards for Drug Non-Clinical Research” “The terms used in this standard are defined as follows:
(1) Non-clinical research refers to various toxicity tests conducted by the experimental system under laboratory conditions for the evaluation of drug safety, including single-dose toxicity tests, repeated-dose toxicity tests, and reproductive toxicity tests , Genotoxicity test, carcinogenicity test, local toxicity test, immunogenicity test, dependence test, toxicokinetic test and other tests related to the evaluation of drug safety.
(2) Non-clinical safety evaluation research institutions refer to laboratories engaged in non-clinical drug research.
(3) Experimental system refers to animals, plants, microorganisms, organs, tissues, cells, genes, etc. used for toxicity testing.
(4) Quality assurance department refers to a department within a non-clinical safety evaluation and research institution that performs the quality assurance function related to non-clinical research work.
(5) The person in charge of a topic refers to the person responsible for organizing and carrying out a certain research work.
(VI) Test products refer to drugs for non-clinical research or substances intended to be developed as drugs.
(VII) Reference substance refers to a substance that is compared with the test article in non-clinical research.
(8) Original data refers to the original observation records and related paper materials that record the research work, including work records, various photos, microfilms, microfilms, computer printing materials, magnetic carriers, and automatic instrument recording materials.
(nine) specimen refers to any material collected from the experimental system for analysis, observation and determination.
(X) The entrusting unit refers to the unit entrusting non-clinical safety evaluation and research institutions to conduct non-clinical research.
(eleven) batch number refers to a group of numbers or letters plus numbers used to identify the “batch” to ensure the traceability of the test or reference product.
Responsibilities of non-clinical safety evaluation research institutions
1. Keep a copy of the master plan, experiment plan and summary report of non-clinical research institutions;
2. Review the experimental plan, experimental records and summary report;
3. Carry out an inspection of each study, and formulate an inspection and inspection plan based on its content and duration, record the details of the inspection, the problems found, the measures taken, etc., and sign the records for preservation for future reference;
4. Regular inspection of animal feeding facilities, laboratory instruments and file management;
5. Report the problems and suggestions found in the inspection to the person in charge of the organization and/or the person in charge of the topic;
6. Participate in the formulation of standard operating procedures and save copies of standard operating procedures.