Drug Safety Evaluation

Medicilon has a professional team and practical experience in drug safety evaluation, and can provide high-quality data and fast turnaround to support various drug safety evaluation studies. Toxicology studies can be performed in accordance with non-GLP or GLP standards. Our research platform has been rated as the Shanghai R&D public service platform.

Medicilon drug safety evaluation service

1. Single and multiple dose toxicity test (rodent)

2. Single and multiple dose toxicity test (non-rodent)

3. Reproductive toxicity test (section I, section II, section III)

4. Genotoxicity test (Ames, micronucleus, chromosome aberration)

5. Carcinogenicity test

6. Local toxicity test

7. Immunogenicity test

8. Safety pharmacological test

9. Toxicokinetic test

Single-dose toxicity test Repeated-dose toxicity test Immunogenicity test Local toxicity test Safety pharmacological test

Genetic Toxicity Test Reproductive Toxicity Test Pharmacokinetics Toxicity Pathology/Clinical Test

Contact us: www.medicilon.com

Email: marketing@medicilon.com

The concept and research content of drug safety

Drug safety evaluation is to clarify the toxicity and potential hazards of drugs through animal experiments and observations of the population to determine whether they can enter the market or clarify safe use conditions to minimize their harmful effects and protect human health.
The research content of drug safety evaluation includes pre-clinical safety evaluation, clinical safety evaluation and post-marketing safety re-evaluation.

Purpose of preclinical safety evaluation

1. Support human clinical trials and guide the design of various phases of clinical trials (selection of the subject population, dosage, dosage regimen, and selection of indicators for monitoring drug safety and efficacy) 2. Maximize the benefit/risk ratio of drug development

2. Discover any potential unknown toxicity and target organs

Limitations or uncertainties of animal testing for drug safety assessment

1. Limitations

Humans and experimental animals have different sensitivity to drug reactions.
Animals cannot describe the toxic effects of subjective perception (pain, fatigue, dizziness, vertigo, tinnitus, etc.);
Animal experiments can observe the animal’s physical signs, but cannot find the animal’s symptoms.

2. Uncertainty

The toxicity of drugs at high doses and low doses may be inconsistent. The number of experimental animals used in drug safety evaluation is limited, and there is uncertainty in extrapolating the results of a small number of animal experiments to the use of drugs in a large number of people. Subjects have different health indexes and different susceptibility to drug reactions. (Experimental animals are all cultivated in the laboratory, and adult healthy animals are selected, and the response is single; and the population is of different races and races, including elderly, frail, and diseased individuals, and there are differences in susceptibility to drug reactions)

Drug safety evaluation regulations, norms, and guidelines

1. Regulations:

“Drug Administration Law of the People’s Republic of China” “Administrative Measures for Drug Registration” Annex 1
Registration classification of Chinese medicines and natural medicines and requirements for application materials Attachment 2
Chemical drug registration classification and application data requirements Annex III
Registration Classification of Biological Products and Requirements for Filing Documents Annex IV
Drug Supplementary Application Registration Items and Application Document Requirements Annex 5
Drug re-registration application materials items

2. Specification:

“Non-clinical Drug Research Quality Management Standards”
“GB 19489-2004 Laboratory Biosafety General Requirements”
Laboratory animal management regulations and laboratory animal quality management methods and standards
“Regulations on the Administration of Laboratory Animals”
“Measures for the Quality Management of Laboratory Animals”
“GB 19423-2001 Genetic Quality Control of Mammal Laboratory Animals”
National Compulsory Standards for Laboratory Animal Feed
National Mandatory Standards for Laboratory Animal Environment and Facilities
National Mandatory Standards for Microbiological Testing of Laboratory Animals
Local regulations on the management of experimental animals

The safety evaluation agency is a basic issue of new drug research. Having a new drug safety evaluation agency that can meet the GLP standard makes it a concrete manifestation of the basic ability of new drug research. At present, there are 1702 non-clinical drug research institutions in my country, of which more than 300 are engaged in or intend to engage in drug safety evaluation research. However, only a few relevant units or institutions in a few provinces and cities nationwide have passed the national GLP certification, which marks the above-mentioned few provinces and cities. It will form its own system in new drug research and has formed an absolute advantage.

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