Impact of pharmacometrics on drug approval and labeling decisions: A survey of 42 new drug applications

  title={Impact of pharmacometrics on drug approval and labeling decisions: A survey of 42 new drug applications},
  author={Venkatesh Atul Bhattaram and Brian P. Booth and Roshni P. Ramchandani and Bach Nhi Beasley and Yaning Wang and Veneeta Tandon and John Z. Duan and Raman K. Baweja and Patrick J. Marroum and Ramana S. Uppoor and Nam Atiqur Rahman and Chandrahas G. Sahajwalla and J. Robert Powell and Mehul U. Mehta and Jogarao V. S. Gobburu},
  journal={The AAPS Journal},
The value of quantitative thinking in drug development and regulatory review is increasingly being appreciated. Modeling and simulation of data pertaining to pharmacokinetic, pharmacodynamic, and disease progression is often referred to as the pharmacometrics analyses. The objective of the current report is to assess the role of pharmacometrics at the US Food and Drug Administration (FDA) in making drug approval and labeling decisions. The New Drug Applications (NDAs) submitted between 2000 and… CONTINUE READING


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