FDA revises 1999 draft guidance on population pharmacokinetics
The FDA on Thursday released revised draft guidance to help keep sponsors informed on the data and model requirements for population pharmacokinetics (PK) analyses submitted as part of new drug applications and biologic license applications.
Since the original population PK guidance was published in 1999, the FDA says the number of applications relevant for population PK analysis has increased and, “The sophistication and reliability of population PK analysis methods have improved.”
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.