Evidence map›Paper›PMID 35501528›Full record

ReviewThe AAPS journal2022

A Critical Overview of the Biological Effects of Excipients (Part II): Scientific Considerations and Tools for Oral Product Development.

Marilyn N Martinez, Fang Wu, Balint Sinko, David J Brayden, Michael Grass, Filippos Kesisoglou, Aaron Stewart, Kiyohiko Sugano

Abstract readReview
PubMed Publisher
In one paragraph

Review in The AAPS journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. Article
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

8 authors.

Marilyn N MartinezOffice of New Animal Drug Evaluation, Center for Veterinary Medicine, US Food and Drug Administration (FDA), Rockville, Maryland, USA. marilyn.martinez@fda.hhs.gov.ORCID http://orcid.org/0000-0002-4512-853X
Fang WuDivision of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), FDA, Silver Spring, Maryland, USA.
Balint SinkoPion Inc, 10 Cook Street, Billerica, Maryland, 01821, USA.
David J BraydenSchool of Veterinary Medicine and UCD Conway Institute, University College Dublin, Belfield, Dublin, D04 V1W8, Ireland.
Michael GrassLonza Small Molecules R&D, 64550 Research Rd, Bend, Oregon, 97701-8583, USA.
Filippos KesisoglouPharmaceutical Sciences and Clinical Supply, Merck & Co., Inc, Rahway, New Jersey, USA.
Aaron StewartLonza Small Molecules R&D, 64550 Research Rd, Bend, Oregon, 97701-8583, USA.
Kiyohiko SuganoMolecular Pharmaceutics Lab, College of Pharmaceutical Sciences, Ritsumeikan University, 1-1-1, Noji-higashi, Kusatsu, Kyoto, Shiga, 525-8577, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

It is now recognized that a number of excipients previously considered to be "inert" have the capacity to alter drug oral bioavailability through a range of in vivo effects. The various mechanisms through which an excipient can affect in vivo gastrointestinal physiology and drug absorption characteristics were explored in "A Critical Overview of The Biological Effects of Excipients (Part I): Impact on Gastrointestinal Absorption." The next critical issue that needs to be discussed is how these biological effects are evaluated. Therefore, in Part 2 of this critical overview, the in vitro, in vivo, and in silico methods for evaluating excipient effects are considered. Examples are provided to illustrate how such studies employing these various procedures have been used to promote formulation understanding and optimization. Finally, a discussion of how the Center for Drug Evaluation and Research applies these tools to support biowaivers is provided.

Indexed as

ExcipientsIntestinal AbsorptionBiological AvailabilityExcipientsbioavailabilityexcipient effectsex vivo methodsin situ methodsin vitro assaysmodeling and simulation

Identifiers

PMID35501528

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.