Get Fabs if no iv data... [Dissolution / BCS / IVIVC]

posted by yjlee168 Homepage – Kaohsiung, Taiwan, 2019-06-19 09:36  – Posting: # 20341
Views: 758

Hi Thalita,

If you do not have iv data for your subjects and you still want to get Fabs (fraction cumulative absorption in %) and then do Levy plots, I think probably you can do the following:
  1. fit your data with one-compartment PK model, to get Ka, Kel & Vd;
  2. use obtained 'Kel' to calculate Fabs (R codes as follows);
  3. plot Fabs vs. FRD (from your dissolution profiles, varied pH) and get Levy plots.
In this case, you do not need iv data and no more IVIVC or Wagner-Nelson. However, I am not sure if this is what you want.

» ... I just tried to calculate Fabs based on Wagner Nelson equation, but the values ​​of Fabs were higher than 1. The Kel is too little. On my work group we have a study that used same in vivo data with GastroPlus and establish the correlation based on one-compartment model, because we do not have intravenous data.

R codes
for (j in 1:length(W.split)){  ### 'W.split' contains in-vivo data for all subj., j = # of subj.
  auc<- 0;Ft<- 0;Fabs<- 0
  for(i in 2:length(W.split[[j]][["time"]])){
# calculate AUC for each time point
  auc[i]<- (W.split[[j]][["time"]][i]-W.split[[j]][["time"]][i-1])*(W.split[[j]][["conc.obs"]][i]+W.split[[j]][["conc.obs"]][i-1])* 0.5
  auc[i]<- auc[i]+auc[i-1] 
# calculate F(t): fraction of absorption at time t
  Ft[i]<-W.split[[j]][["conc.obs"]][i]+kel*auc[i]}
# calculate AUC (0~INF)
  auc.infinity<-W.split[[j]][["conc.obs"]][length(W.split[[j]][["conc.obs"]])]/kel
  aucINF<-auc[length(W.split[[j]][["conc.obs"]])]+auc.infinity
# calculate Fabs(t): cumulative absorption fractions at time t
  Fabs<- 0
  for(i in 2:length(W.split[[j]][["time"]])) Fabs[i]<-(Ft[i]/(kel*aucINF))*100

All the best,
-- Yung-jin Lee
bear v2.8.6:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan http://pkpd.kmu.edu.tw/bear
Download link (updated) -> here

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