Evidence map›Paper›PMID 31897807›Full record

ReviewAAPS PharmSciTech2020

Application and Impact of Human Dose Projection from Discovery to Early Drug Development.

Dipal Patel, Wenzhan Yang, Maya Lipert, Tian Wu

Abstract readReview
PubMed Publisher
In one paragraph

Review in AAPS PharmSciTech, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 60% of its field
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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. A Holistic Review of the Preclinical Landscape for Long-Acting Anti-infective Drugs Using HIV as a Paradigm.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Review
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

4 authors at 4 institutions in 1 country.

Dipal PatelDepartment of Metabolism and Pharmacokinetics, Bristol-Myers Squibb Research and Development, Princeton, New Jersey, 08543, USA. dipal.patel@bms.com.
Wenzhan YangEarly Product Development, Pharmaceutical Sciences, R&D, AstraZeneca, Boston, Massachusetts, 02451, USA.
Maya LipertMRL, Merck & Co., Inc., Kenilworth, New Jersey, 07033, USA.
Tian WuDrug Product Technologies Amgen Inc., Thousand Oaks, California, 91320, USA.
Amgen (United States) · USAstraZeneca (United States) · USBristol-Myers Squibb (United States) · USMerck & Co., Inc., Rahway, NJ, USA (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The application and impact of human dose projection (HDP) has been well recognized in the late drug development phase, with increasing appreciation earlier during discovery and early development. This commentary describes the perspective of pharmaceutical scientists on the evolving application and impact of HDP at various phases from discovery to early development, including lead generation, lead optimization, lead up to candidate nomination, and early drug development. The underlying fundamental concepts and key input parameters for HDP are briefly discussed. A broad overview of phase-specific tools and approaches commonly utilized for human dose projection in the pharmaceutical industry is provided. A discussion of phase-appropriate implementation strategies, associated limitations/assumptions and continuous refinement for HDP from discovery to early development is presented. The authors describe the phase-specific applications of human dose projection to facilitate key assessments and relative impact on decision points.

Indexed as

AnimalsChemistry, PharmaceuticalDose-Response Relationship, DrugDrug DesignDrug DevelopmentDrug DiscoveryDrug IndustryForecastingHumansPharmaceutical PreparationsPharmacokineticsPharmaceutical Preparationsdiscovery strategiesearly developmenthuman dose projectionPK/PD

Identifiers

PMID31897807
OpenAlexW3003080932

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.