Background Traditionally, most monoclonal antibodies (mAbs) have been dosed based on
body weight because of perceived contribution of body size in pharmacokinetic variability …

Pembrolizumab is a monoclonal antibody that targets the programmed death-1 receptor to
induce immune-mediated clearance (CL) of tumor cells. Originally approved by the US Food …

Advances in immuno‐oncology have provided a variety of novel therapeutics that harness
the innate immune system to identify and destroy neoplastic cells. It is noteworthy that …

Recently, immunotherapy has yielded promising results in several cancer types. Contrary to
the established classical chemotherapy‐dosing paradigm, a maximum tolerated dose …

The purpose of this work was to present a consolidated set of guidelines for the analysis of
uncontrolled concomitant medications (ConMed) as a covariate and potential perpetrator in …

Estimation of systemic exposure after absorption of any xenobiotic from the skin is very
important in development of dermal pharmaceutical products as well as assessing un …

Abstract Talimogene Laherparepvec (T‐VEC) is a first‐in‐class oncolytic virotherapy
approved for the treatment of unresectable melanoma recurrent after initial surgery …

Leucine‐rich repeat kinase 2 (LRRK2) inhibitors are currently in clinical development as
interventions to slow progression of Parkinson's disease (PD). Understanding the rate of …

A recent industry perspective published in this journal describes the benefits received by
drug companies from participation in the MIDD Pilot Program. Along with the primary …

Stepwise covariate modeling (SCM) is a widely used tool in pharmacometric analyses to
identify covariates that explain between-subject variability (BSV) in exposure and exposure …