Medicilon is a company engaged in pre-clinical research services (CRO), which specializes in providing customers with customizable pre-clinical trial service programs. Professional knowledge in pharmacodynamic research and toxicology. Provide you with high-quality data and fast turnaround to support various drug development, preclinical research and clinical research. Help you select the most valuable drug candidates into the clinical trial application stage. Medicilon’s pre-clinical research service consists of three parts: pharmacokinetics, disease transplantation animal models, and drug safety evaluation. Covers all aspects: program design, in vivo research, sample analysis, professional data analysis, IACUC review, etc., as well as application data preparation.
•Pharmacokinetics
• Pharmacokinetics and tissue distribution research
•Bioavailability research
•Multi-cycle cross-dosing trial
• Cassette dosing test
•Gender differences research
•medicine interactions
• Comply with FDA or CFDA pharmacokinetic application materials
•Biological analysis
• Method development and validation
•Determination of dosing concentration
•Preclinical and clinical sample analysis
• Pharmacokinetic and toxicokinetic analysis
• Stability research
•LC/MS/MS
•Immunoassay
• In vitro ADME
•In vitro metabolic stability
• P450 inhibition/induction
•Presumption and identification of metabolites
• Plasma protein binding rate
•Permeability test
•Isotope Service
•Protein drugs-pharmacokinetics
•Using isotope bioassay in vitro
•Research on tissue distribution and excretion in the body
•Single/repeated administration toxicity test
•Safety pharmacology test Toxicokinetic test
•Genetic toxicity test Reproductive toxicity test
•Immunogenicity test Local toxicity test
• Conventional and characteristic dyeing techniques
•Prepare high-quality pathological sections
• Advanced automated equipment: sectioning and embedding box marking machine, automatic tissue dehydration machine, automatic staining machine
• Pathology reading by professional pathologists at home and abroad
•hematology
• Urinalysis
•Clinical Biochemistry
• Blood clotting
Monkey Room
contact us
Email: Marketing@medicilon.com
Phone: 02158591500
——————-Remark———————
“Non-clinical Drug Research Quality Management Standards” (Bureau Order No. 2)
Chapter 6: Implementation of Research Work
Article 25 Each research should have a topic name or code, and it should be unified in the relevant documents and experiment records
Use the name or code name.
Article 26 All specimens collected in the experiment should be marked with thematic name or code, animal number and date of collection.
Article 27 The person in charge of the topic shall formulate the experiment plan, which shall be executed after the inspection by the quality assurance department and the approval of the person in charge of the agency. The approval date shall be the start date of the experiment. For the commissioned research, the experimental plan should be approved by the commissioning unit.
Article 28 The main contents of the experimental program are as follows:
(1) The name or code of the research topic and the purpose of the research;
(2) The name and address of the non-clinical safety evaluation research institution and the entrusting unit;
(3) Names of the person in charge of the topic and the staff participating in the experiment;
(4) The name, abbreviation, code, batch number, related physical and chemical properties and biological characteristics of the test substance and reference substance;
(5) Experimental system and reasons for selection;
(6) The species, line, number, age, sex, weight range, source and grade of experimental animals;
(7) Identification method of laboratory animals;
(8) Environmental conditions for the breeding and management of laboratory animals;
(九) The name or code of the feed;
(10) Solvents, emulsifiers and other media used in experiments;
(11) The route, method, dosage, frequency and duration of administration of the test substance and reference substance and the reasons for the choice;
(12) Documents and literature on the guidelines for toxicity studies used;
(13) Detection methods and frequency of various indicators;
(14) Data statistical processing method;
(15) Where to save experimental data.
Article 29 When it is necessary to modify the experimental protocol during the research process, it shall be reviewed by the quality assurance department and approved by the person in charge of the agency. The content, reason and date of the change should be recorded in the file and kept together with the original experimental protocol.
Article 30 The person in charge of the topic is fully responsible for the operation and management of the research topic. The staff participating in the experiment should strictly implement the experimental plan and the corresponding standard operating procedures, and report to the person in charge of the topic in time when an abnormal phenomenon is found.
Article 31 The record of all data shall be timely, direct, accurate, clear and difficult to eliminate, and the date of record shall be indicated and the recorder shall sign. When the recorded data needs to be modified, the original record should be kept clearly and identifiable, the reason for the modification and the modification date should be indicated, and the modification should be signed.
Article 32 When an animal develops a disease caused by a non-test product or an abnormal situation that interferes with the purpose of the study, it shall be immediately isolated or put to death. When medication is needed, it should be approved by the person in charge of the topic, and the reasons for the treatment, approval procedures, inspections, drug prescriptions, treatment dates and results should be recorded in detail. Treatment measures must not interfere with research.
Article 33 After the research work is completed, the person in charge of the topic shall write a summary report in time, sign or seal it, and submit it to the person in charge of the quality assurance department for review and signature, and the person in charge of the institution shall approve it. The approval date is used as the end date of the experiment.
Article 34 The main contents of the summary report are as follows:
(1) The name or code of the research topic and the purpose of the research;
(2) The name and address of the non-clinical safety evaluation research institution and the entrusting unit;
(3) The start and end dates of the research;
(4) The name, abbreviation, code, batch number, stability, content, concentration, purity, composition and other characteristics of the test substance and reference substance;
(5) The species, line, number, age, sex, weight range, source, animal qualification number and issuing unit, receiving date and breeding conditions of experimental animals;
(6) The route, dosage, method, frequency and duration of administration of the test substance and reference substance;
(7) Dosage design basis for test substance and reference substance;
(8) Abnormal conditions that affect the reliability of research and cause research work to deviate from the experimental plan;
(9) Various index detection methods and frequencies;
(10) The name of the person in charge of the topic and all the personnel participating in the work and the content of the work undertaken;
(11) Statistical methods used to analyze data;
(12) Experimental results and conclusions;
(13) The place where the original data and specimens are kept.
Article 35. After the summary report is signed by the person in charge of the agency, if it needs to be modified or supplemented, the relevant person shall explain in detail the content, reason and date of the modification or supplement. Approval by the head of the agency.
marketing@medicilon.com
