Evidence map›Paper›PMID 33144077›Full record

ReviewRegulatory toxicology and pharmacology : RTP2020

Considerations for setting occupational exposure limits for novel pharmaceutical modalities.

Jessica C Graham, Jedd Hillegass, Gene Schulze

Abstract readReview
In one paragraph

Review in Regulatory toxicology and pharmacology : RTP, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

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

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. An Industry Proposal for a Cell and Gene Therapy Safety Data Sheet.Applied biosafety : journal of the American Biological Safety Association · 2023
    Article
  6. Occupational Exposure Risks When Working with Protein Therapeutics and the Development of a Biologics Banding System.Applied biosafety : journal of the American Biological Safety Association · 2021
    Article
  7. 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

3 authors.

Jessica C GrahamBristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ, 08903, USA. Electronic address: jcgraham411@gmail.com.
Jedd HillegassBristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ, 08903, USA.
Gene SchulzeBristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ, 08903, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In order to develop new and effective medicines, pharmaceutical companies must be modality agnostic. As science reveals an enhanced understanding of biological processes, new therapeutic modalities are becoming important in developing breakthrough therapies to treat both rare and common diseases. As these new modalities progress, concern and uncertainty arise regarding their safe handling by the researchers developing them, employees manufacturing them and nurses administering them. This manuscript reviews the available literature for emerging modalities (including oligonucleotides, monoclonal antibodies, fusion proteins and bispecific antibodies, antibody-drug conjugates, peptides, vaccines, genetically modified organisms, and several others) and provides considerations for occupational health and safety-oriented hazard identification and risk assessments to enable timely, consistent and well-informed hazard identification, hazard communication and risk-management decisions. This manuscript also points out instances where historical exposure control banding systems may not be applicable (e.g. oncolytic viruses, biologics) and where other occupational exposure limit systems are more applicable (e.g. Biosafety Levels, Biologic Control Categories).

Indexed as

Drug IndustryPharmaceutical PreparationsBacteriaBiological ProductsDecision TreesHumansOccupational ExposureOccupational HealthOligonucleotidesOncolytic VirusesProteinsRadiopharmaceuticalsRisk AssessmentSafety ManagementVaccinesBiological ProductsOligonucleotidesPharmaceutical PreparationsProteinsRadiopharmaceuticalsVaccinesEngineered bacteriaExposure control bandOccupational exposure limitOccupational healthOncolytic virusPET TracerPharmaceutical modalitiesProtein therapeuticVaccine safetyWorker safety

Identifiers

PMID33144077
PMCPMC7605856

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.