Precision Dosing Using PBPK Modeling

With the discovery of newer drugs, the “one-size-fits-all” approach towards therapy is becoming a thing of the past. The new paradigm of precision medicine aims at delivering the right treatment at the right time to the right patients. An integral part of precision medicine is administration of a precise dose, which is a critical step … Continued

Getting at the HAART of Precision Dosing: Using PBPK Models to Optimize Dosing of an Antiviral

Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used as part of highly active antiretroviral therapy (HAART) for the treatment of a human immunodeficiency virus (HIV) type 1. It is primarily metabolized by CY2B6. A standard dose of efavirenz has been associated with serious adverse reactions in poor metabolizers (PMs) of CYP2B6, necessitating a reduction … Continued

The Evolving Landscape of Drug Development in China

Pharma innovation will continue to increase in China as product differentiation grows in importance. As a result, the percent of generics on the Chinese market will continue to decrease and the number of novel new drug applications will increase.

Get Ready for CDISC-SEND!

Towards the end of 2016, the US Food and Drug Administration (FDA) and the Japan Pharmaceuticals and Medical Devices Agency (PMDA), will require electronic submissions of certain nonclinical data using the CDISC SEND standard format. Other regulatory agencies, including the European Medical Agency (EMA), Korean Ministry of Food and Drug Safety, and China Food and … Continued

Reference-scaled Average Bioequivalence

The standard approach for approval of generic drugs is to run a bioequivalence study to demonstrate that a generic product is comparable to an  approved (ie, reference) drug in their rate and extent of absorption. The rate and extent of drug absorption are determined from the pharmacokinetic parameters: peak concentration (Cmax) and the area under … Continued