New drug development is a systematic project, and the corresponding CRO service also covers the entire process of drug development from the discovery stage, pre-clinical research, clinical research to new drug registration and declaration.
The basic process of new drug development
- Formulate research plan, design and implement experimental plan, and obtain NCE
- Pre-clinical research, obtain IND (investigational new drug)
Topic Selection and Demonstration——Proposal——Design Plan——Preclinical Research——Clinical Trial Application and Approval——Clinical Trial——Production Application and Approval——Transfer or Protection——Commissioning and Sales
Pre-clinical 22 items of Western medicine (new drug certificate, 25 items)
19 pre-clinical Chinese medicines (new drug certificate, 22)
3.Clinical trial (or clinical verification), obtain NDA (new drug approval)
Phase I: 20-30 healthy subjects
Phase II: not less than 100 typical patients
Phase III: not less than 300 patients
4.Post-marketing research, clinical pharmacology
Phase I trial production period, Phase IV: >2000 cases
New drug R&D features: high investment/long cycle/high risk/high profit/high competition
Four elements of creating new medicine
Selection of biological targets
Determination of the detection model
Lead compound discovery: Refers to newly discovered compounds that exhibit definite pharmacological activity against certain targets and models.
Lead compound optimization
Common R&D issues
Effectiveness evaluation-Insufficient support for indications/functions
Safety evaluation-it is difficult to ensure the safety of the clinical drug population, potentially serious and unacceptable consequences
Comprehensive evaluation-no obvious advantages compared with the listed varieties (safety, effectiveness, compliance)
Medicilon is known as one of the drug R&D outsourcing service companies (CRO). It has established a company in Shanghai that integrates compound synthesis, compound activity screening, structural biology, pharmacodynamic evaluation, pharmacokinetic evaluation and toxicology evaluation. The comprehensive technical service platform in line with international standards has been recognized by the international drug administration. Medicilon is one of the companies that have achieved internationalization in China’s local CRO. In 2008, it established an animal experiment company in cooperation with MPI Research in the United States. The animal experiment facility has obtained the International Laboratory Animal Evaluation and Accreditation (AAALAC) and China Food and Drug Administration GLP certificate, and has reached the US Food and Drug Administration GLP standards. Medicilon will help customers achieve their goals faster with efficient and cost-effective one-stop professional services.
Medicilon is a CRO company that provides a complete set of pre-clinical approval applications that meet both Chinese GLP and US GLP standards.
It is a CRO company that provides preclinical animal trials for the international community.
A pre-clinical CRO joint venture company established with a large foreign CRO company (US MPI Research).
A CRO company providing structural biology and chemical biology services.
A CRO company that provides “foreign pharmaceutical companies-CRO-domestic pharmaceutical companies” tripartite cooperation.
Passed one of the AAALAC certifications and complies with the US FDA and CFDA GLP standards.
It is one of the Chinese GLP certification and domestic Chinese companies that have achieved internationalization.
Has a professional R&D team and more than ten years of experience in R&D outsourcing services.
New drugs refer to drugs that have not been produced in my country. According to the requirements of approval management, new drugs are divided into traditional Chinese medicine, chemical drugs and biological drugs (new drug approval methods).
The above is about the new drug research and development CRO company, new drug research and development outsourcing service company content, from the Medicilon official website.