Evidence map›Paper›PMID 42634398›Full record

ReviewJournal of clinical pharmacology2026

Application of Model-Informed Approaches in Neuroscience Drug Development and Regulatory Decision-Making.

Michael Bewernitz, Anantha Ram Nookala, Gopichand Gottipati, Praveen Balimane, Venkateswaran C Pillai, Jeffry Florian, Adarsh Gandhi, Kevin Krudys, David Lee, Dawei Li and 16 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Michael Bewernitz *Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0009-0005-8754-117X
Anantha Ram Nookala *Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0000-0003-2191-2589
Gopichand Gottipati *Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0009-0009-5654-5345
Praveen BalimaneOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Venkateswaran C PillaiOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Jeffry FlorianOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0009-0000-1984-8026
Adarsh GandhiOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Kevin KrudysOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
David LeeOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Dawei LiOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Min LiOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Zhihua LiOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0000-0002-2772-0839
Jie LiuOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Rajanikanth MadabushiOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0000-0001-8686-9652
Grimstein ManuelaOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0000-0002-6430-3022
Mehul MehtaOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0000-0003-4973-3822
Srikanth C NallaniOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0000-0001-7145-6230
Nimishraj PanseOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0009-0005-2479-5404
Wei QiuOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Sreedharan SabarinathOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Vishnu SharmaOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Li TanOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Ramana UppoorOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0009-0009-1459-9062
Yun XuOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Hao ZhuOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0000-0002-3858-2048
Venkatesh Atul BhattaramOffice of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Model-informed drug development (MIDD) approaches are being increasingly used in neuroscience drug development programs and regulatory decision-making. In this work, the authors summarize a select set of cases in neurology, psychiatry, addiction, anesthesia, and analgesia, where MIDD approaches were utilized to address critical drug development questions or fill knowledge gaps. These examples include efficacy considerations such as biomarker-clinical endpoint relationships, surrogate endpoints for accelerated approval, extrapolation of efficacy, and safety aspects such as informing driving studies. Additionally, the examples also inform optimal dosing regimen selection, dose adjustments in drug interactions, life cycle management decisions such as indication expansion, formulation switching, and informing patient population selection. Together, these examples offer insights into the utility of MIDD approaches to streamline drug development and opportunities to save costs and resources.

Indexed as

Decision MakingDrug DevelopmentNeurosciencesAnimalsHumansaddictiondrug developmentmedicineneurosciencepatient population regimenrisk analysissurrogate endpoint

Identifiers

PMID42634398
PMCPMC13501072

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.