fatmaelzahraa ● 20071106 16:19 (5809 d 03:53 ago) Posting: # 1289 Views: 13,672 

I am a research chemist..... really we have a drug to do bioequivalence study.... I am new in this field.... as I a experienced in dissolution testing, HPLC, but I am so bad in stastical calculations and also the main idea of this study, and its results indication... Please can u help me to be a good one.....? what should I know? what should I read? 
Helmut ★★★ Vienna, Austria, 20071108 14:47 (5807 d 05:25 ago) @ fatmaelzahraa Posting: # 1291 Views: 11,474 

Dear fatmaelzahraa! ❝ ... I am so bad in stastical calculations and also the main idea of this study, and its results indication... For a summary of basic designs see this thread. ❝ Please can u help me to be a good one.....? ❝ what should I know? I would start with:
❝ what should I read? For a collection of textbooks see this post. National and international guidelines are given here. — Diftor heh smusma 🖖🏼 Довге життя Україна! _{} Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes 
drrammohanj ● 20071220 09:32 (5765 d 10:40 ago) @ Helmut Posting: # 1401 Views: 10,967 

Dear Helmut, I am not a Biostatistician, I know that all biological samples follow normal distribution before or after log transformation of data, in present context PK data. when I see a statistical report, I won't understand the statistical report after log tranformation of Pk data, like point estimate, CV, ANOVA, pvalue, ttest, least square mean (LSM) etc. can you give me algorithm of calculation of data. I think it is very difficult question for you to answer with best regards Ram Mohan 
Helmut ★★★ Vienna, Austria, 20071220 14:15 (5765 d 05:57 ago) @ drrammohanj Posting: # 1404 Views: 12,127 

Dear Ram! ❝ … that all biological samples follow normal distribution before or after log transformation of data, in present context PK data. It’s a common consensus that some metrics follow a normal distribution (untransformed data, additive model), e.g., A_{e} (amount excreted), whilst others follow a lognormal distribution (multiplicative model), e.g., AUC, C_{max},… Due to the sampling schedule the theoretical continous metric t_{max} has to be assessed by nonparametric methods (valid for discrete data). Rationale behind assuming a multiplicative model (i.e., performing the analysis on logtransformed data):
❝ when I see a statistical report, I won't understand the statistical report after log tranformation of Pk data, like point estimate, CV, ANOVA, pvalue, ttest, least square mean (LSM) etc. What are you problems in particular? Maybe the report is not clearly written. Generally PE and the confidence interval should be backtransformed into the linear domain. Example: Acceptance range [0.80, 1.25] (Napierian log: [0.2231, +0.2231]) Unity 1.0 (log: 0) PE [CI] from study's ANOVA on logdata: 0.02314 [0.1231, +0.07686] Backtransformation: PE: ℯ^{–0.02314} = 0.9771 (or 97.7%) CI: ℯ^{–0.1231} = 0.8841 (88.4%), ℯ^{+0.07686} = 1.080 (108%) ❝ can you give me algorithm of calculation of data. Please refer to this post. As a starter I would recommend Hauschke et al. (2007), Patterson & Jones (2006), and Chow & Liu (2000). ❝ I think it is very difficult question for you to answer No, not at all… … but not within even a couple of posts! — Diftor heh smusma 🖖🏼 Довге життя Україна! _{} Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes 