Bioequivalence test also known as BE test, refers to the use of bioavailability research methods, using pharmacokinetic parameters as indicators to compare the same or different formulations of the same drug under the same test conditions. The human body test whether there is statistical difference in the absorption degree and speed of the active ingredient. “Generic Drug Quality Consistency Evaluation” mainly re-evaluates the quality of oral solid preparations of chemical drugs approved before the promulgation and implementation of the new version of “Administrative Measures for Drug Registration”, including tablets, capsules and granules, etc. The evaluation mainly To investigate the consistency of pharmacy quality and efficacy, Medicilon has established a “comprehensive service platform for quality consistency evaluation of generic drugs” to provide customers with generic drug consistency evaluation services.
Consistency evaluation mainly includes pharmaceutical research and bioequivalence (BE) testing. my country is a big country of generic drugs. Now the consistency evaluation is in full swing. The cost of BE testing is also rising. This article will briefly describe what the cost of BE testing mainly includes .
On the one hand, because of the urgent time, arduous tasks, strict test process requirements, heavy penalties, shortage of domestic clinical research institutions, and shortage of supply, the price of BE trials in China has increased.
On the other hand, the price of BE testing is also related to the nature of the drug itself. For drugs with high variability, the number of subjects needs to be increased in the BE test; drugs with a long half-life, during the BE test, lead to a long time for blood collection from the patient and correspondingly prolong the hospital stay of the subjects; for drugs with large side effects, the BE test needs to respond accordingly Increase subject compensation, etc.
Furthermore, if companies need to carry out pre-tests, corresponding costs will inevitably increase.
The price of the BE test mainly includes four parts: hospital expenses, testing expenses, clinical CRO service fees, and statistical expenses.
Different hospitals charge differently. The hospital fees mainly include management fees (meals, hospitalization fees, drug management fees, institutional clinical quality control fees, etc.), monitoring fees (labor fees for investigators), screening and physical examination fees, and subject compensation fee.
It mainly includes methodology development and verification, test analysis report, and biological sample test. The factors that affect the price are: the difficulty of methodological development, such as the methodological development of compound prescription is more difficult than unilateral; in addition, there are more blood sampling points for subjects, and the cost of biological sample testing will increase.
The fee for statistical analysis of data is mainly based on the difficulty of the clinical trial program and the sample size. The cost of data statistical analysis includes two parts: data analysis and statistical analysis. Data analysis refers to data management. Data is divided into endogenous data and exogenous data. Each department cooperates to complete the data reception, entry, cleaning, coding, consistency check, data locking and conversion, and finally the data management personnel After the data is processed and analyzed, it is sent to the statistician in a certain format. Statistical analysis means that the statistician analyzes the data passed by the data manager and gives a clinical trial statistical analysis report.
Clinical CRO service fee refers to medical service fee and clinical audit fee. To complete a BE project, the cost of different companies is not much different. This part of the work mainly includes the preparation of clinical trial plans, informed consent forms, screening of clinical trial centers, preparation and submission of ethical data, project initiation, mid-term audits, document management, project management, quality assurance and quality control, etc.
The clinical CRO company is mainly responsible for coordinating the entire clinical trial, tracking the progress of the clinical trial, and supervising the standardization of the entire trial. The clinical CRO company has a highly specialized team with rich clinical research experience, which can be used as a borrowable external resource for pharmaceutical companies, which can reduce the management costs of the entire pharmaceutical company and improve efficiency. Medicilon Biopharmaceuticals is a CRO company. The company has a GLP-qualified animal laboratory and testing center. It can use large animals such as beagles or cynomolgus monkeys to conduct animal BE experiments, and provide data support for the optimization of preparations and reduce Clinical BE risk.
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