Evidence map›Paper›PMID 32779046›Full record

ArticleThe AAPS journal2020

Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations.

Lei Miao, Youssef M Mousa, Liang Zhao, Kimberly Raines, Paul Seo, Fang Wu

Abstract read
PubMed Publisher
In one paragraph

Article in The AAPS journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
4.0field-weighted citation impact, top 6% 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

20 citing papers in PubMed, 37 citations in OpenAlex.

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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

6 authors at 2 institutions in 1 country.

Lei MiaoDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Youssef M MousaDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Liang ZhaoDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Kimberly RainesDivision of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Paul SeoDivision of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Fang WuDivision of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA. Fang.Wu@fda.hhs.gov.
Center for Drug Evaluation and Research · USUnited States Food and Drug Administration · US

Funding

Machine Learning for Drug Response PredictionR35GM133346 · NIGMS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Yuanfang Guan · 2019 to 2026
$3.2M
6 · The paper itself

Abstract

Bioequivalence (BE) studies support the approval and clinical use of both new drug and generic drug products. Virtual BE studies have been conducted using physiologically based pharmacokinetic absorption models (PBPK AMs) to aid the evaluations of generic drug products. The aim of the current study is to determine the dissolution boundary for maintaining BE between the test and reference oseltamivir phosphate (OP) drug products using the PBPK AM-based virtual BE studies in adults and pediatrics. The adult PBPK AM for OP and its metabolite oseltamivir carboxylate (OC) are developed and verified/validated using intravenous and oral data from multiple generic OP products. The pediatric PBPK AM is extrapolated from the adult PBPK AM. The virtual BE analysis is conducted using simulated PK profiles from the reference products and the generic products with theoretical dissolution profiles as inputs. Results indicate that the generic products with 10% slower dissolution profile than the pivotal reference bio-batch could still maintain BE to the reference in adults. In contrast, a stringent trend of dissolution boundary is observed for pediatrics (6% slower for adolescents, 4% slower for 0-2-month neonates) to maintain BE. This study addresses the important applications of PBPK AM in evaluating BE in different age populations, mitigating risk of formulation/batch changes, and providing a quantitative basis for setting clinically relevant dissolution specifications for OP and OC in both adults and pediatrics.

Indexed as

Models, TheoreticalAbsorption, PhysiologicalAdultAntiviral AgentsChildHumansOseltamivirTherapeutic EquivalencyAntiviral AgentsOseltamivirbioequivalencedissolutionoseltamivirpediatricphysiologically based pharmacokinetic absorption model

Identifiers

PMID32779046
OpenAlexW3047938321

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.