In this third and final post about by review of the Phoenix WinNonlin software, I review the newest feature of the software and provide overall thoughts. You can read about the Phoenix platform in Part 1 of my review, and the non-compartmental and single subject analysis in Part 2 of my review. With the exception … Continued
Part 2 of the WinNonlin review will cover the non-compartmental and PK modeling functions of Phoenix WinNonlin. To many people, these two features have defined WinNonlin for many years. And the updated software does not disappoint with significant improvements to the functionality, ease of use, automated graphics, and other features. As I discussed in Part … Continued
Mechanistic PKPD models are now advocated not only by academic and industrial researchers, but also by regulators. A recent development in this area is based on the growing realisation that innovation could be dramatically catalysed by creating synergy at the interface between Systems Biology and PKPD, two disciplines which until now have largely existed in … Continued
WinNonlin by Certara has been a fixture in pharmacokinetic analysis software for over 20 years. While it has been known as a tool for non-compartmental analysis and model-based analysis of single subject data, the new Phoenix WinNonlin creates an entirely new platform for pharmacokinetic and pharmacodynamic analysis. Similar to my other reviews. I will be evaluating features … Continued
In drug development, clinical medicine, or health policy making, basing one’s decisions on a selective part of the available evidence can pose a major threat to the health of patients and the society. If, for example, primarily positive research reports are taken into account, one could wrongfully conclude that a harmful drug is safe.
UDP-glucuronosyltransferases (UGTs) are critical for the metabolism and clearance of drugs, chemicals, and hormones. The development of UGT1A1 and 1A6 was studied in 50 pediatric liver samples using bilirubin, serotonin activity assays, and Western blot as well as pharmacokinetic scaling. UGT activity developed age dependently in pediatric liver. Maximal activity of 0.7690 nmol · min … Continued
It is imperative that new drugs demonstrate adequate pharmacokinetic properties, allowing an optimal safety margin and convenient dosing regimens in clinical practice, which then lead to better patient compliance. Such pharmacokinetic properties include suitable peak (maximum) plasma drug concentration (Cmax), area under the plasma concentration-time curve (AUC) and a suitable half-life t(½). The Cmax and … Continued
Clofarabine, a newer purine analog with reduced central nervous system toxicity, may prove advantageous in hematopoietic cell transplantation in patients for whom neurotoxicity is a natural part of disease progression. This study evaluated clofarabine pharmacokinetics in adult and pediatric patients undergoing hematopoietic cell transplantation for the treatment of high-risk, inherited metabolic disorders. Clofarabine (40 mg/m(2)/d) … Continued
