Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology
Reference16 articles.
1. Bhattaram VA, Bonapace C, Chilukuri DM, Duan JZ, Garnett C, Gobburu JV, et al. Impact of pharmacometric reviews on new drug approval and labeling decisions—a survey of 31 new drug applications submitted between 2005 and 2006. Clin Pharmacol Ther. 2007s;81(2):213–21.
2. Bhattaram VA, Booth BP, Ramchandani RP, Beasley BN, Wang Y, Tandon V, et al. Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications. AAPS J. 2005;7(3):E503–12.
3. Lee JY, Garnett CE, Gobburu JV, Bhattaram VA, Brar S, Earp JC, et al. Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008. Clin Pharmacokinet. 2011;50(10):627–35.
4. FDA. Guidance for industry: population pharmacokinetics. 2022 https://www.fda.gov/media/128793/download. Accessed 24 June 2022.
5. EMA. Guideline on reporting the results of population pharmacokinetic analyses. 2008 https://www.ema.europa.eu/documents/scientific-guideline/guideline-reporting-results-population-pharmacokinetic-analyses_en.pdf Accessed 24 June 2022.
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