Evidence map›Paper›PMID 34894779›Full record

ReviewClinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis

General Considerations for Diversifying Heparin Drug Products by Improving the Current Heparin Manufacturing Process and Reintroducing Bovine Sourced Heparin to the US Market.

Ali Al-Hakim

Open access · goldAbstract readReview
In one paragraph

Review in Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
1.5field-weighted citation impact, top 19% 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

17 citing papers in PubMed, 24 citations in OpenAlex.

  1. The Content and Location of 3-Biomolecules · 2026
    Article
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Heparin: Over 100 Years of Anticoagulation.Handbook of experimental pharmacology · 2026
    Review
  8. Article
  9. Review
  10. Review
  11. Article
  12. Article
  13. Review
  14. Article
  15. Quantitative Risk Evaluation of Adventitious Agents in Heparin.TH open : companion journal to thrombosis and haemostasis · 2023
    Review
  16. Pharmacokinetic, Hemostatic, and Anticancer Properties of a Low-Anticoagulant Bovine Heparin.TH open : companion journal to thrombosis and haemostasis · 2022
    Article
  17. Blended Heparin: A new Perspective to Guarantee the Supply of a Life-Saving Drug?Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    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

1 author at 1 institution in 1 country.

Ali Al-HakimOffice of New Drug Products, OPQ/CDER/FDA, Silver Spring, USA.ORCID https://orcid.org/0000-0002-4403-6609
Center for Drug Evaluation and Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Heparin is one of the most widely used drugs in the world. It has been described as a lifesaving drug due to its roles in treating many serious diseases and illnesses including kidney dialysis, surgery, cardiac-invasive, heart attack, cardiac arrhythmia, acute coronary syndrome, pulmonary embolism, stroke, deep vein thrombosis, blood clot prevention, and many other related uses. Heparin drug products currently approved in the United States are obtained from porcine intestinal mucosa sourced from pigs, the majority of which is imported from China. However, due to the heparin contamination crisis (2008) and potential shortage and to safeguard the quality of current and future heparin supply chains including raw material, Food and Drug administration (FDA) posted a notification on its website titled "FDA Encourages Reintroduction of Bovine-Sourced Heparin". This perspective is intended to address the history of regulatory and scientific background of heparin drug products obtained from bovine and porcine sources and general recommendations for improving the quality of current heparin manufacturing process including Critical Quality Attributes (CQA), control management, process control, related tests, limits, etc. Additionally, a general plan with systematic steps is proposed for diversifying heparin supply chains by reintroduction of bovine sourced heparin to the US market.

Indexed as

AnimalsAnticoagulantsCattleDrug DevelopmentHeparinHumansThromboembolismUnited StatesAnticoagulantsHeparinanticoagulantsheparin-induced thrombocytopeniaheparins

Identifiers

PMID34894779
PMCPMC8678904
OpenAlexW4200284203

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.