RECENT SPOTLIGHT ON CDER SCIENCE

CDER continues with its Spotlight on CDER Science series featuring the Center’s noteworthy scientific and research-oriented activities. Recent posts include:

Translating In Vitro Antiviral Activity to the In Vivo Setting: A Crucial Step in Fighting COVID-19  As the international research community seeks to develop new drugs to combat COVID-19 and to assess the potential of existing drugs for this purpose, CDER researchers outline the challenges and important considerations in  translating data on the in vitro antiviral activity and potency of possible drug  treatments for COVID-19 to the in vivo setting, including  the appropriate design of dosing regimens in clinical trials. Learn more.

IN PRESS

“Unless otherwise indicated, the opinions expressed in these articles are those of the authors and should not be interpreted as the position of the U.S. Food and Drug Administration.”

Extrapolation of adult efficacy to pediatric patients with chemotherapy-induced nausea and vomiting. Momper JD, Heinrichs MT […] Mulugeta Y J Clin Pharmacol 2020 Jun;60(6):775-84 Chemotherapy-induced nausea and vomiting (CINV) is a common adverse event that impairs the quality of life of children with cancer. Momper et al.  evaluated the feasibility of extrapolating efficacy results from adults to pediatric populations for drugs to treat CINV and that extrapolation of was plausible for 5-hydroxytryptamine-3 and neurokinin-1 receptor antagonist antiemetics.

The effect of drug combinations on the kinetics of the emergence of antibiotic resistance in E. coli CFT073 using the in vitro hollow fiber infection model. Garimella N, Zere T […] Weaver JL  Int J Antimicrob Agents 2020 Apr;55(4):105861 Using a hollow-fiber infection model (HFIM) to analyze the emergence of antibiotic resistance in Escherichia coli (E. coli), Garimella et al. demonstrated that double or triple antibiotic combinations significantly delayed the emergence of resistant E. coli subpopulations.

Evaluation of commercially available meth-deterrent pseudoephedrine hydrochloride products Rahman Z, Aqueel MS […] Ashraf M Int J Pharm 2020 Feb 15;575:118909 As pseudoephedrine can be used as starting material for producing methamphetamine, some over-the-counter pseudoephedrine products have recently been promoting that they are “meth-deterrent.” Rahman et al.  showed that pseudoephedrine is just as extractable from some products promoted as “meth-deterrent” as from  products  that did not make such claims.

Multivariate data analysis of growth medium trends affecting antibody glycosylation. Powers DN, Trunfio N […] Agarabi C Biotechnol Prog 2020 Jan;36(1):e2903 Powers et al. manufactured therapeutic antibodies in a series of microbioreactors and used multivariable analytic techniques to identify combinations of variables that were associated with desired product attributes such a specific protein glycosylation. The overall goal of the research is a manufacturing approach that will permit us to ensure critical quality attributes in the manufacture of complex biotherapeutics.

Adaptation for Regulatory Application: A Content Analysis of FDA Risk Evaluation and Mitigation Strategies Assessment Plans (2014–2018) Using RE-AIM Toyserkani GA, Huynh L, Morrato EH Front. Public Health, 25 February 2020 The authors characterized and evaluated REMS assessment plans using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework and observed heavy focus on Implementation measures. They discuss the usefulness of a systematic application of the RE-AIM framework for improving REMS programs and the potential of implementation science to benefit FDA’s decision-making.