Quanticate has developed automated systems using the latest versions of Phoenix WinNonlin® and SAS® to deliver high quality pharmacokinetic (PK) reports, along with additional PK, pharmacodynamic (PD), and PK/PD services, including:
All work is performed in accordance with relevant GCP, ICH, EMEA, and FDA guidelines.
One of the main reasons for drug attrition in clinical development is poor pharmacokinetics (PK) [Kola and J. Landis, Nature Reviews Drug Discovery, 3, 711-715 (2004)]. To reduce this risk, it is essential to fully investigate the pharmacokinetics of a new drug during each stage of development.
At the present time, the regulatory and drug development communities are adapting to a rising trend in biosimilar development in a number of therapeutic areas. The regulatory framework for...Read more
In this recorded presentation a member of the Quanticate's Statistical Programming Team explores the creation of two ADaM datasets; ADPC and ADPP for Pharmacokinetic (PK) Analysis. Video...Read more
The Clinical Data Interchange Standards Consortium (CDISC) is a global not-for-profit organization that develops standards to support the acquisition, exchange, submission, and archive of data...Read more