Re: PK simulation and replicates

From: 약리학교실 Date: January 21, 2026 technical Source: mail-archive.com
Dear Marie Rajerson, The following is my opinion. 1) For simulations without inter-indivdual and intra-individual random variability: you would not need to worry about the number of replicates. 2) For simulations with inter-individual and intra-individual variability: 2-1) If you are doing a clinical trial simulation: The clinical trial design and group size you would like to evaluate decides the number of replicates. 2-2) If you are estimating the distribution of some variable (e.g., AUC), you can conduct power analysis for the number of replicates needed to achieve a certain level of precision for the central tendency and variability of that variable. However, a big enough number of replicates(e.g., 10000) suffices for precise estimation of the distribution, even without power analysis. Sincerely, Jun Seok Cha
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________________________________ 보낸 사람: [email protected] <[email protected]> 님이 Marie Rajerison <[email protected]> 님을 대시하여 보냄 보냄: 목요일, 1월 22, 2026 12:30:25 오전 받는 사람: Nmusers <[email protected]>; [email protected] <[email protected]> 제목: [NMusers] PK simulation and replicates Dear NM users Happy new year! Is there a regulatory guideline or general rule/recommendation regarding the number of replicates to use in a popPK simulation and the impact on the distribution of the simulated variables? Thank you in advance for your help Kind regards Marie 상기 메일은 지정된 수신인 만을 위한 것이며 부정경쟁 방지 및 영업비밀보호에 관한 법률을 포함하여 관련 법령에 따라 보호의 대상이 되는 영업비밀, 산업기술 등을 포함하고 있을 수 있습니다. 본 문서에 포함된 정보의 전부 또는 일부를 무단으로 제3자에게 공개, 배포, 복사 또는 사용하는 것은 엄격히 금지됩니다. 본 메일이 잘못 전송된 경우, 발신인에게 알려주시고 즉시 삭제하여 주시기 바랍니다. The above message is intended solely for the named addressee and may contain trade secret, industrial technology or privileged and confidential information otherwise protected under applicable law including the Unfair Competition Prevention and Trade Secret protection act. Any unauthorized dissemination, distribution, copying or use of the information contained in this communication is strictly prohibited. If you have received this communication in error, please notify the sender by email and delete this communication immediately.
Jan 21, 2026 Marie Rajerison PK simulation and replicates
Jan 21, 2026 약리학교실 Re: PK simulation and replicates
Jan 21, 2026 Jakob Ribbing Re: PK simulation and replicates
Jan 21, 2026 Kenneth G. Kowalski RE: PK simulation and replicates