开题报告内容：（包括拟研究或解决的问题、采用的研究手段及文献综述，不少于2000字）
Background
Pharmacists are responsible for supplying appropriate drug information to patients. In particular, the plasma concentration of drugs after oral administration is useful for instruction on the use of drugs for patients. For example, we can make the plasma concentration-time graph according to the prediction result and show this profile to patients. It is helpful for achieving medication compliance of patients. Furthermore, we can improve this program to help administration planning when the prediction results reach high precision.
The most common source of drug information in Japan is Package Insert (PI). And we can also search for Interview Form (IF), which would give more details of the drugsrsquo; pharmacokinetic parameters. Not every drug has an IF. However, data from PI and IF are still insufficient for predicting the plasma concentration of drugs. In this study, we try to establish the method for estimating the absorption rate constant (ka) from the parameters obtained by PI and also IF using Excel VBA. Then we try to apply this method to drugs for diabetes [1] and hypertension [2] approved in Japan to evaluate its availability.
Content
In this study, we are going to predict the pharmacokinetics of drugs orally administrated to patients by an established method using Excel VBA. This method estimates the absorption rate constant (ka) from time of maximum concentration (Tmax) and elimination rate constant (kel). In addition, the method can also calculate the distribution volume (Vd) and bioavailability (F) from dose (D) and maximum plasma concentration (Cmax) using followed equation: V/F=(D/Cmax)*exp(-kel*Tmax).
Parameters will be predictable if the data used is from orally administration for once.
This study mostly includes four parts as below:
- Usefulness evaluation
Before usefulness evaluation, we try to collect information from diabetes and hypertension drugs up to resent years for a preparation. After information collecting, we use the Excel VBA program to calculate kel, ka, V and CLtot of each drug, and compare these data to the information written in PI or IF. In this way, the usefulness and accuracy of the program can be evaluated. Moreover, if the simulation result has big differences from the data recorded in documents, we can use the information collected to analyze the reasons and find the problems of the program for further improvement.
- Program improvement
Because the program is now limited to orally administration for only once, we cannot apply the method to actual clinical activities. For instance, many drugs need to be taken continuously. Also, this program can only apply to drugs under one-compartment formulation, while there are drugs obey two-compartment or other formulations. Last but not least, accuracy also attaches great importance to application in medical activities of this program. As a result, if the programming principles can be found, we can improve the simulation program and upgrade its accuracy as well.
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