Evidence map›Paper›PMID 30997588›Full record

ArticleThe AAPS journal2019

Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: "Drug Products, Including Biological Products, that Contain Nanomaterials".

Jon S B de Vlieger, Daan J A Crommelin, Katherine Tyner, Daryl C Drummond, Wenlei Jiang, Scott E McNeil, Sesha Neervannan, Rachael M Crist, Vinod P Shah

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The AAPS journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 1 pooled it
–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

63 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  15. The effect of cryoprotectant and storage conditions on the aggregation of poly(ethylene glycol)-poly(α-benzyl carboxylate-ε-caprolactone) nanoparticles.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2026
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3 more citing papers are in PubMed but not listed here.

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

9 authors.

Jon S B de VliegerFoundation Lygature, Utrecht, The Netherlands. Jon.deVlieger@lygature.org.
Daan J A CrommelinDepartment of Pharmaceutics, Utrecht University, Utrecht, The Netherlands.
Katherine TynerCenter for Drug Evaluation and Research, Office of Pharmaceutical Quality, US Food and Drug Administration, Silver Spring, Maryland, USA.
Daryl C DrummondMerrimack Pharmaceuticals, Cambridge, Massachusetts, USA.
Wenlei JiangCenter for Drug Evaluation and Research, Office of Generic Drugs, Office of Research and Standards, US Food and Drug Administration, Silver Spring, Maryland, USA.
Scott E McNeilNanotechnology Characterization Laboratory, Cancer Research Technology Program, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA.
Sesha NeervannanAllergan Plc, Irvine, California, USA.
Rachael M CristNanotechnology Characterization Laboratory, Cancer Research Technology Program, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA.
Vinod P ShahVPS Consulting LLC, North Potomac, Maryland, USA.

Funding

NCI NIH HHS HHSN261200800001E
6 · The paper itself

Abstract

To guide developers of innovative and generic drug products that contain nanomaterials, the U.S. Food and Drug Administration issued the draft guidance for industry titled: "Drug Products, Including Biological Products, that Contain Nanomaterials" in December 2017. During the AAPS Guidance Forum on September 11, 2018, participants from industry, academia, and regulatory bodies discussed this draft guidance in an open setting. Two questions raised by the AAPS membership were discussed in more detail: what is the appropriate regulatory pathway for approval of drug products containing nanomaterials, and how to determine critical quality attributes (CQAs) for nanomaterials? During the meeting, clarification was provided on how the new FDA center-led guidance relates to older, specific nanomaterial class, or specific product-related guidances. The lively discussions concluded with some clear observations and recommendations: (I) Important lessons can be learned from how CQAs were determined for, e.g., biologics. (II) Publication of ongoing scientific discussions on strategies and studies determining CQAs of drug products containing nanomaterials will significantly strengthen the science base on this topic. Furthermore, (III) alignment on a global level on how to address new questions regarding nanomedicine development protocols will add to efficient development and approval of these much needed candidate nanomedicines (innovative and generic). Public meetings such as the AAPS Guidance Forum may serve as the place to have these discussions.

Indexed as

Guidelines as TopicBiological ProductsDrug ApprovalDrug IndustryDrugs, GenericGovernment RegulationNanostructuresUnited StatesUnited States Food and Drug AdministrationBiological ProductsDrugs, Generic

Identifiers

PMID30997588
PMCPMC6470106

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.