The State Food and Drug Administration (CFDA) recently held a working conference in Beijing，Adhere to the implementation of the State Council's opinion on the consistency evaluation of the quality and efficacy of the State Council。Subsequent，Heilongjiang、Shanxi、Zhejiang and other provinces have released a work plan to promote the implementation of the consistency evaluation of generic drugs。Current，Enterprise -oriented generic drug consistency evaluation work has been started，Many companies are more enterprises to find differences between their own products and reference preparations through the results of in vitro dissolution and pre -BE tests，Data generated around clinical research and clinical trials，Explore the path of finding a consistency evaluation of generic drug products。

 

  Data analysis solving differences

 

  Test data quality is self -evident for the significance of consistency evaluation work。October 26-31, 2015，CFDA Application for some drug registration applications that have been submitted for self -examination information was conducted on site inspection of clinical trial data，and subsequently released the "Announcement on the Application of 11 Drug Registration Applications of 8 Enterprises"，This file clearly points out the lack of or incomplete original records in the process of clinical trials in the process of clinical trials、Clinical trial data is not real and other problems，Especially in data analysis，Basically there are selective data and modification data。

 

  Wang Shuaiai, general My stake betting appmanager stake online sports bettingof Guangzhou Haibote Pharmaceutical Technology Co., Ltd.，Looking back at the verification results at the time，Of course there are many reasons，If the institutional ability is limited、Main researchers (PI) insufficient energy、Test standards are irregular。In addition，Data cannot be traceable, and it is a common problem，Equipment for all clinical trials should have an audit trajectory，But in the past phase Ⅰ clinical clinical did not attach importance to not enough attention。& ldquo; From the perspective of biological sample detection，There are 100%of the 11 varieties that are not approved.，But you still need to explore the condition through pre -trials，Is the selected detection method the best detection method，and many process problems，such as preparation and quality standards, etc.，Do you need higher -level detection methods and detection equipment，All need to refer to the real and rigorous data results for discussion。& rdquo;

 

  Dested，If the main test of the main test is calculated according to the cost of 24 subjects, it is calculated，For most preparation companies that develop consistency evaluations，The supervision level of preclinical research and clinical trials is not the same as on the same day，Raising 24 cases or 36 cases of BE test，Great risk is no different from gambling。Because of this，Enterprise combined with its own variety characteristics，When the product prescription process is still not grasped，Perform pre -tests for small scale，and refer to the data results to carry out relevant analysis work，Continuous adjustment and perfect process，The path followed by many enterprises to promote consistency evaluation。

 

  Dr. Bao Liheng, Chairman of the Taiwan Society of Taiwan Association, Dr. Bao Liheng, pointed out: & ldquo; Through data analysis of the BE test, you can determine whether the preparation prescription process is appropriate，By understanding the basic attributes of the drug，What kind of category belongs to BCS classification，Different composition and characteristics of the formula preparation，Drug particles、Is the crystal type the same，Comprehensive review whether the generic drug is similar to the reference preparation，help to confirm whether the concentration of drug concentration in the blood in the blood is rigorous; evaluate the degree of mutation of drugs in the human body;。& rdquo;

 

  Is the analysis method stake online sports bettingappropriate stake betting appfor blood drug concentration in blood，According to the data result of the pre -trial，It can be found that the sensitivity of the analysis can be found，For example, when confirming the analysis method，The blood sample should be clean，But the test results found that there are more things，or expected blood drug components can be measured for 36 hours，But only 8 hours are measured，or the occurrence of interference with the occurrence of substances is related to the subject of eating in private。

 

  Another，In terms of degree of mutation，Draw the blood concentration of generic drugs and reference preparations on the same figure，Reference Preparation CMAX is only 30%and the generic drug is 50%，The reference preparation AUC is only 25%and the generic drug is 35%，These can be comprehensively analyzed through the data results; in terms of blood drawing time，The more blood drawing points, the higher the detection and analysis cost，Therefore, the blood collection before CMAX blood collection point is actually unnecessary，The first blood time point should be cmax，If the blood collection time is not sure，Miss cmax，The highest value of the blood concentration can not be displayed on the curve chart，Results must not be ideal。& ldquo; Is the test site appropriate，Whether the personnel have been trained，Blood centrifugal、Separation、Storage and other biological sample processing processes is compliant，Is the related equipment qualified and enough，Available in the management of the subject，Data results can reflect the clue。& rdquo;

 

  Data quality grasped details

 

   & ldquo; Whether the formula formula of the preparation formula is reasonable、Clinical trial execution is beyond flaw、Is the analysis method appropriate & rdquo; It is the three major issues in the BE test，Even if the formula of generic drugs and reference preparations is exactly the same，But if the clinical trial does not meet the GCP requirements，or the detection and analysis did not do well，or the clinical trial institution has been checked and did not pass，Consistency evaluation will still fail。& ldquo; The three are interlocking structural chains，BE is an extremely important link in consistent evaluation，But this is the prescription in the early stage with the variety、Research and pharmaceutical research is closely combined with inseparable。So，Clinical and clinical studies must be promoted in cooperation in order to better complete the consistency evaluation Stake Sports Bettingwork。& rdquo; Wang Shuai Shuai said that。

 

  Stake Sports BettingCurrent，Including pharmacokinetics research、Biological equivalent test、Pharmaceuticals, including the tolerance test of the drug, are carried out in the phase I clinical research room of the institution，Typical representatives such as Beijing Union Hospital、Peking University Hospital，and Fudan University、Zhejiang University、More than 50 clinical trial institutions including affiliated hospitals such as Sun Yat -sen University and other universities。But，From the clinical trial process，& ldquo; Blood collection & rdquo; and & ldquo; test & rdquo;，No more than 20 in total，Most of the remaining phase I clinical trial agencies are mainly blood collection，This puts forward higher requirements for the quality control of clinical trials。

 

  Design of the BE test solution，Many people in the industry often think: & ldquo; Since it is a generic drug，Just do it with reference to the original research product。& rdquo; But，Actually not so simple，BE test detection Analysis data results are not ideal，Whether the design of the clinical trial scheme is sufficiently precise，Many detail management also has a great impact on the test results，Problems such as specimen、Questions of equipment and facilities、Saved problems, etc. are also important reasons。

 

  According to the requirements of the regulatory authorities，Affordable for the clinical of Phase I must have the corresponding tissue and personnel conditions，If the hospital must pass the GCP qualification identification/review inspection，and is a third -level hospital，Emergency Division、ICU, etc. The clinical emergency department has advanced rescue techniques and abilities; aspect of the organizational structure，The phase I clinical research room must be approved by the hospital，There must be a written approach、Appointment file，and reasonable organizational structure and full -time personnel，and strict authority management and confidentiality measures，No serious quality problems or record records of serious violations。

 

  Researchers，Must have qualified certification materials，The person in charge of the State Research Office of Phase I，Requirements with more than 5 years of management experience and 5 or more new categories 1 new medicine I project，Specific responsibilities include appointment of full -time personnel，Organization stake sports betting appto formulate a management My stake betting appsystem、SOP, etc.，review、Approval plan and report，Establish an effective communication mechanism; quality assurance person in charge、Pi must have systematic clinical pharmacological knowledge。

 

  Although the clinical safety risk of new drugs is higher，But the requirements of consistency evaluation are not low for quality specifications，Because of the original research medicine as a benchmark，It must be operated in accordance with the high standard specifications of the original drug。Li Su, director of the Institution Office of the Sun Yat -sen University Tumor Prevention Center, gives an example in an interview，The clinical trial area must be safe，Some areas need to install an emergency call and monitoring system; the infrastructure requires that there should be uninterrupted power and emergency facilities。& ldquo; In particular, some private items storage areas，Sometimes the subject will bring food or snacks，Many times do be，Especially for multiple administrations, it requires an empty stomach，But the subject will steal food because of hunger，This will affect the authenticity of the test data，The results of the influence consistency evaluation; biological samples are also very important for BE，Therefore, uninterrupted power supply must be guaranteed。& rdquo;