Steps of drug project establishment
1, study the basic information of drugs.
You can query the data of the original drug under the consistency evaluation database, or you can query it in the "orange book" or "generic reference preparation catalogue". This step can determine the reference preparation of the drug, and the internationally listed drugs can check the instructions of the drug. These main purposes are to clarify indications and determine reference preparations.
Main research data (reference preparation)
2. Investigate the listing situation at home and abroad.
You can query domestic listed and unlisted drugs and global listed drug data in China Drug Review and China Drug Approval. The main purpose of this step is to analyze the competition and check the number of competitors. You can also analyze the difficulty of the trial, which can also be inquired by the Food and Drug Administration, but the comprehensive database data is more comprehensive and more conducive to analysis.
This part mainly asks about market acceptance and consistency evaluation (analyzing competitors), clinical declaration (reporting progress and BE difficulty) and CDE raw material declaration, mainly to give us a general understanding of the project.
Listing at home and abroad
3. Investigate patent data
Patent data is very important. Patent property right is one of the core points of pharmaceutical companies. To investigate patents, we need to investigate core patents, family patents, process patents, etc. These may require teamwork. The main purpose is to avoid patent infringement by querying global patent data and China patent data.
Patent data survey
4. Investigate the clinical advantages.
The greater the clinical safety and advantages of drugs, the greater the market for this drug. You can query the safety of drugs in the clinical database and identify the clinical advantages of drugs.
5, query market data
Querying market data and drug sales data requires professional databases. Another way is to check the annual reports of listed companies, the fragmented data on WeChat official accounts, and the information on major wealth websites and snowballs. But the only problem with these data is that the data accuracy is not high and the integration is troublesome. You can query the drug sales data of pharmacies and hospitals: analyze the market prospect and calculate the input-output ratio.
Market data
6. Ask about raw materials.
You can inquire about the basic information of APIs (the best synthetic route, intermediates, samples, etc.). ), quality standards and feasibility, mainly technical evaluation. In the final stage, you can query these data in the API database.
Finally, the project evaluation and decision-making stage. Database can help all the data you want to know in drug project research, provide decision-making for project research, support drug research and development, and of course, database can also make decision-making for drug investment.