JP3291717B2 - Chemical test data management system - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a drug test data management system for recording a change in the condition of a living body when a drug is administered to the living body.

[0002]

2. Description of the Related Art The safety of humans, such as carcinogenicity and toxicity of pharmaceuticals, pesticides, food additives, and other chemical substances, is tested in clinical trials before they are marketed.
Confirmation has been performed in non-clinical tests using animals such as rats and mice.

[0003] In a safety test of a drug or the like using such an animal, toxicity is generated if the dose is administered to a single dose.
A single dose toxicity test that reveals what its toxicity characteristics are,
Repeated dose toxicity studies to characterize doses and toxicity at which no or no change in toxicity is observed during repeated administration, and to clarify the effects on parental reproduction and the development of the next generation, etc. Reproductive and developmental toxicity tests, D
Including mutagenicity tests to determine the presence or absence of substances that are harmful to NA and mutagenic properties, carcinogenicity tests, skin sensitization tests, skin photosensitization tests, dependence tests, etc. Various tests are performed.

[0004] In each of the above tests, a drug is actually administered to an animal, and measurement of body weight, food, water, urine, etc., biochemical examination, hematological examination, observation of clinical symptoms, various pathological findings, and the like are performed. Do
This is done by analyzing the collected data.

[0005] Such a safety test is carried out prior to a clinical test in which the drug is actually administered to the human body, and ultimately affects the human body. You need to understand and analyze the impact accurately. For this reason, computer systems have been used for data recording, management and analysis.

[0006] As described above, since drugs such as pharmaceuticals affect the human body, data management in the above-described safety test is performed so that the data is not falsified. Strict standards are set by the government and other government agencies. Such criteria are collectively referred to as “GLP (Good Laboratory Pr.)
and the computer system that manages the data must also meet the GLP criteria.

[0007] Needless to say, the system design itself must conform to the GLP, but when the system is introduced, it is confirmed whether the system operates properly in conformity with the GLP. It is necessary to confirm the operation at the time of introduction (acceptance inspection). In the GLP, system deficiencies are on the receiving side of the system, and acceptance inspection is of great importance. On the other hand, the above operation check is performed not only at the time of introduction but also during system operation.
If the system is updated at regular intervals or when a part of the system is upgraded, it is confirmed that the system is compliant with the GLP and that it operates reliably. You must also ensure that there is no tampering.

[0008]

[Problems to be solved by the invention]

However, in the conventional system, it takes a considerable amount of time and labor to check the operation, and in the ordinary system, it has to be performed by two or three persons over three months or more. For this reason, although acceptance inspection is performed at the time of system introduction, once the system starts operation,
The fact is that no periodic operation check was performed at all. Under such circumstances, the software itself can be used with general-purpose hardware, but if a general-purpose machine is used, it will be necessary to confirm the operation only by updating the operation system or other software that is not linked, so it is practically necessary Had to prepare a dedicated machine, and the cost of introducing the system was very high.

The present invention has been made in view of such circumstances, and has as its object to provide a drug test data management system that can automatically confirm operation during system operation and reliably guarantee GLP and the like. I do.

[0011]

In order to achieve the above object, a drug test data management system of the present invention is a drug test data management system for managing data such as changes in symptoms of a living body when a drug is administered to a living body. A procedure storage means for storing a procedure for operation check, a result storage means for storing a result of the operation check, and an operation check automatically executed in accordance with the procedure for operation check stored in the procedure storage means The gist of the present invention is to provide a confirmation executing means for performing the above, and a result comparing means for comparing the result of the operation confirmation by the confirmation executing means with the result of the operation confirmation stored in the result storage means.

That is, the medicine test data management system of the present invention comprises: a procedure storage means for storing an operation confirmation procedure;
A result storage unit for storing the result of the operation check, a check execution unit for automatically executing the operation check according to the operation check procedure stored in the procedure storage unit, and a result of the operation check by the check execution unit. And a result comparing means for comparing the result of the operation check stored in the result storing means. For this reason, for example, while storing the procedure of the operation check performed during the acceptance inspection at the time of system introduction,
The inspection result is stored. Then, from the second operation check, the operation is automatically checked by the check execution unit, and the result is compared with the result of the operation check at the time of system introduction stored in the result storage unit to determine the test result. It can be performed.

As described above, by automatically performing the second and subsequent operation confirmations, it is possible to end the operation in less than one night, which has conventionally required two to three persons for more than three months. Become. Therefore, not only regular operation check during system operation, but also frequent operation check when updating the operating system or other unlinked software can ensure GLP etc. reliably. become. In addition, since the operation can be checked frequently, a general-purpose machine can be used, and the introduction cost of the system can be significantly reduced.

In the chemical test data management system of the present invention, the procedure storage means stores an operation confirmation procedure performed at the time of system introduction, and the result storage means stores the operation confirmation result at the time of system introduction. In this case, the procedure for confirming the operation that is inevitably performed at the time of the acceptance inspection is stored, and the operation is confirmed for the second and subsequent times.
Even if it is not a uniform package system but a system customized for each system
After the first time, it is possible to automatically perform the necessary operation check for each receiving destination.

In the drug test data management system of the present invention, when used for a toxicity test of a drug using an animal as a living body, the toxicity test of the drug using an animal as a living body is enormous and various. Since data processing is required, the cost of introducing the system is required to be low, and the effect of using a general-purpose machine is remarkable and effective.

[0016]

Next, embodiments of the present invention will be described in detail.

FIG. 1 is a system configuration diagram showing one embodiment of the chemical test data management system of the present invention. This system measures the weight of a drug when it is actually administered to an animal,
A data input means 3 for inputting various data such as amounts of food, water, urine, etc. and clinical findings; a data processing means 4 for receiving the data input to the data input means 3 and performing processing such as totaling; And a data storage unit 7 for storing input data, totalization results, and the like via the data processing means 4. In the figure, 13 is a storage device such as a hard disk, and 14 is a computer device having a central processing unit, a memory, and the like.

Further, there are provided a data output means 5 for outputting the data tabulated by the data processing means 4 to a form or the like, and a display unit 6 for displaying various information at the time of data input or data output.

Here, the system is operated normally by the above-mentioned means. In addition, in the acceptance inspection performed when the system is introduced before the operation of the system, various data are actually input to the data input unit 3 and the data processing unit 4 performs counting and the like, and an accurate counting result is obtained. This is done by confirming the fact and recording the obtained accurate totaling result as a record.

The results of the acceptance inspection are stored and stored in the result storage means 11 and also as forms output from the data output means.

The system includes a procedure storage means 8 for storing the procedure for confirming the operation at the time of the acceptance inspection described above,
Check execution means 9 is provided for reading out the operation check procedure stored in the procedure storage means 8 and automatically executing the procedure. In the confirmation executing means 9, the second and subsequent operations are confirmed at any time after the end of the acceptance inspection in the same procedure as the acceptance inspection.

Further, the system receives the operation check result executed by the check execution unit 9 and compares the result with the operation check result at the time of acceptance inspection stored in the result storage unit 11. Is provided. Further, in the above system, a confirmation result storage unit 12 for storing the comparison result compared by the result comparing means 10 together with the operation confirmation result.
Is provided. The comparison result and the operation confirmation result are output from the data output means 5.

Next, the operation of the chemical test data management system will be described with reference to the flowchart shown in FIG. In the figure, "S" means a step.

First, when the system is introduced, an acceptance inspection is started (S1). This acceptance test included weight, food, water,
Data such as the amount of urine and the pathological findings are input to the data input means 3, and the data processing means 4 performs counting and the like to confirm that an accurate counting result can be obtained.

At this time, the procedure storage means 8 stores the operation procedure of the acceptance inspection (S2). More specifically, a procedure for inputting data such as weight, food, water, and the like, and processing for totalizing the input data is stored. Then, an accurate totaling result of the input data is confirmed, and when the acceptance inspection is completed, the operation confirmation result in the acceptance inspection is stored in the result storage unit 11.
(S3).

When the acceptance inspection is completed, the actual operation of the system is started (S4). Then, in a normal operation, the operation of the system is continued without executing the second and subsequent operation checks.

When the second and subsequent operations are to be checked,
The operation check procedure at the time of the acceptance inspection stored in the procedure storage means is read (S5 to S6), and the check execution means 9
Weight, food, food,
Processing such as input of data such as water and totalization of the input data is executed (S7).

After execution of the operation check, the result comparing means 10 compares the current operation check result with the operation check result of the acceptance inspection stored in the result storage means 11 (S8). Here, in this operation check, it is automatically determined whether or not the same result as the operation check result in the acceptance inspection is obtained.

Next, the current operation check result and the comparison result are output by the data output means 5 (S9).
It is stored and stored in the confirmation result storage unit 12 (S10). Then, the process returns to step 4, and normal system operation is started again.

As described above, according to the above-mentioned chemical test data management system, the operation of the second and subsequent times is automatically performed, so that two to three persons conventionally required more than three months. However, it will end in less than one night. Therefore, not only regular operation check during system operation, but also frequent operation check when updating the operating system or other unlinked software can ensure GLP etc. reliably. become. In addition, since the operation can be checked frequently, a general-purpose machine can be used, and the introduction cost of the system can be significantly reduced.

Also, since the procedure of operation confirmation that is inevitably performed at the time of the acceptance inspection is stored and the operation confirmation is performed for the second time or later, not a uniform package system but a system customized for each system acceptance destination. Even if there is, it is possible to automatically perform the necessary operation confirmation for each receiving destination from the second time on.

Such a drug test data management system is suitably used for a toxicity test of a drug using an animal as a living body. Toxicity testing of drugs using animals as living organisms,
This is because huge and diverse data processing is required, so that the introduction cost of the system is required to be low, and the effect of using a general-purpose machine is remarkable and effective.

In the above embodiment, the result storage means 11 stores the operation check result of the acceptance inspection at the time of system introduction, and in the second and subsequent operation checks, the operation check result is stored in the operation check at the time of the acceptance inspection. Although the results are compared with the results, the present invention is not limited to this.
Alternatively, the results of the second and subsequent operation confirmations may be stored each time, and in the next operation confirmation, the operation confirmation result may be compared with the previous operation confirmation result.

Further, in the above embodiment, the procedure storage means 8 stores the operation check procedure of the acceptance inspection at the time of introducing the system, and in the second and subsequent operation checks, the operation check is performed by the operation procedure at the time of the acceptance inspection. However, the present invention is not limited to this. The second and subsequent operation check procedures are stored in the procedure storage means 8 each time, and in the next operation check,
The operation check may be performed in the previous operation check procedure.

The system of the present invention is not limited to a toxicological test of a drug using an animal as a living body, but also a pharmacodynamic test, a general pharmacology test, a pharmacodynamic test, or a GCP before entering a safety test using an animal. The present invention can also be applied to a clinical test or the like to which (a standard for conducting a clinical test of a drug) is applied. In addition, it can be applied to non-GLP tests. Even in these cases, the same operation and effect can be obtained.

In the present invention, the drug is not limited to a drug, but includes various chemical substances including agricultural chemicals, food additives, and external preparations for skin.

[0037]

As described above, according to the chemical test data management system of the present invention, the operation of the second and subsequent operations is automatically performed, so that two to three persons can save three months or more. What was needed will be completed in less than one night. Therefore, not only regular operation check during system operation, but also frequent operation check when updating the operating system or other unlinked software can ensure GLP etc. reliably. become. In addition, since the operation can be checked frequently, a general-purpose machine can be used, and the introduction cost of the system can be significantly reduced.

[Brief description of the drawings]

FIG. 1 is a system configuration diagram showing one embodiment of a chemical test data management system of the present invention.

FIG. 2 is a flowchart illustrating the operation of the chemical test data management system.

[Explanation of symbols]

 8 Procedure storage means 9 Confirmation execution means 10 Result comparison means 11 Result storage means

──────────────────────────────────────────────────続 き Continued on the front page (58) Field surveyed (Int. Cl. ⁷ , DB name) G01N 33/15 G06F 19/00

Claims (3)

(57) [Claims] 1. A medicine test data management system for managing data such as a change in a symptom of a living body when a medicine is administered to a living body, comprising: a procedure storage means for storing an operation check procedure; A result storage means for storing, a check execution means for automatically executing an operation check according to the operation check procedure stored in the procedure storage means, and a result of the operation check by the check execution means stored in the result storage means A chemical test data management system, comprising: a result comparing means for comparing the result of the operation check performed. 2. The medicine according to claim 1, wherein the procedure storage means stores an operation check procedure performed when the system is installed, and the result storage means stores the operation check result obtained when the system is installed. Test data management system. 3. The drug test data management system according to claim 1, which is used for a toxicity test of a drug using an animal as a living body.