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:book: 책: R을 사용한 비구획분석과 생물학적동등성 평가, 2020. https://asancpt.github.io/book-ncar

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bookdown clinical-pharmacology noncompartmental-analysis pharmacokinetics pharmacology

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논문 모음

  • Gomeni and Bressolle-Gomeni, Comparison of Alternative Population Modeling Approaches for Implementing a Level A IVIVC and for Assessing the Time-Scaling Factor Using Deconvolution and Convolution-Based Methods, The AAPS Journal (2020) 22:67 https://doi.org/10.1208/s12248-020-00445-0
  • Han et al., First-in-human, double-blind, randomized controlled trial of an oral dose of GnRH antagonist, TU2670 in healthy women, The Journal of Clinical Endocrinology & Metabolism (2020) dgaa939 https://doi.org/10.1210/clinem/dgaa939

Hands-on

엑셀에서 농도-시간 그래프를 그려봅니다.

몇가지 질문: IntAUC() 등

  1. tblNCA에서 iAUC랑 R2ADJ항을 넣으면 오류가뜨는데 왜 그런지 모르겠습니다.
  2. NonCompart에 여러가지 함수가 있다고했는데 글에서는 AUC만 설명되어있는데 이것만 알면 되나요??
  3. tibble이라는 명령어가 어떤건지 잘모르겠습니다.

Basic BE analysis - R code

PROC GLM과 동일한 Type III SS의 ANOVA 표를 위해서는 sasLM 패키지의 aov3(), T3test()함수를 사용합니다.

# PROC GLM equivalent
require(sasLM)
aov3(log(Cmax) ~ GRP/SUBJ + PRD + TRT, BEdata)

#  For RANDOM SUBJ(GRP) /TEST output
T3test(log(Cmax) ~ GRP/SUBJ + PRD + TRT, BEdata, Error="GRP:SUBJ")

PROC MIXED와 동일한 신뢰구간을 구하기 위해서는 nlme 패키지의 lme() 함수를 사용합니다.

# PROC MIXED equivalent
require(nlme)
r2 = lme(log(Cmax) ~ GRP + PRD + TRT, random=~1|SUBJ, data=BEdata)
summary(r2) ; VarCorr(r2)
ci = intervals(r2, 0.90) ; ci 
exp(ci$fixed["TRTT",])

참고문헌

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