ReviewThe AAPS journal2012
Mechanistic determinants of biotherapeutics absorption following SC administration.
Review in The AAPS journal, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 143 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Who cites it
143 citing papers in PubMed, 1 synthesis or guideline pooled it, 351 citations in OpenAlex.
- Systematic Review of Device Parameters and Design of Studies Bridging Biologic-Device Combination Products Using Prefilled Syringes and Autoinjectors.The AAPS journal · 2020Pooled it
- Model-Informed Development of a Subcutaneous Formulation of Tislelizumab: Phase 1 Pharmacokinetics in Patients With Cancer.Clinical and translational science · 2026Trial
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- Cryopreserved umbilical allograft (equicenta® CTM) improves clinical outcomes compared with clinician-selected standard of care in performance horses: a pragmatic prospective controlled trial.Frontiers in veterinary science · 2026Trial
- Pharmacokinetic Bridging Between an Autoinjector and a Prefilled Syringe Following Subcutaneous Administration of Mirikizumab in Healthy Participants.Advances in therapy · 2025Trial
- Mirikizumab Pharmacokinetics and Exposure-Response in Patients With Moderately-To-Severely Active Crohn's Disease: Results From Two Randomized Studies.Clinical and translational science · 2025Trial
- Multiple-Dose Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Subcutaneous Rusfertide, a Hepcidin Mimetic, in Healthy Subjects.Clinical pharmacology in drug development · 2025Trial
- Pharmacokinetic and Safety Profiles of MIT-001, a Novel Ferroptosis Inhibitor, After Subcutaneous Administration in Healthy Participants.Drug design, development and therapy · 2025Trial
- An Open-Label Study to Assess Monthly Risperidone Injections (180 mg) Following Switch from Daily Oral Risperidone (6 mg) in Stable Schizophrenic Patients.Clinical drug investigation · 2024Trial
- Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study of GB223, a Fully-Humanized Monoclonal Antibody to RANKL, in Healthy Chinese Adults.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Trial
- Comprehensive evaluation of microneedle-based intradermal adalimumab delivery vs. subcutaneous administration: results of a randomized controlled clinical trial.British journal of clinical pharmacology · 2021Trial
- Model-Based Selection and Recommendation for Subcutaneous Abatacept Dose in Patients With Polyarticular Juvenile Idiopathic Arthritis.Journal of clinical pharmacology · 2021Trial
- Clinical Evaluation of an Investigational 5 mL Wearable Injector in Healthy Human Subjects.Clinical and translational science · 2021Trial
- Tolerability of eptinezumab in overweight, obese or type 1 diabetes patients.Endocrinology, diabetes & metabolism · 2021Trial
- Pharmacokinetic Time Course Scaling of a Subcutaneously Administered Pegylated Peptide Conjugate for a First-in-Human Investigation.European journal of drug metabolism and pharmacokinetics · 2017Trial
- Efficacy, safety, tolerability and pharmacokinetics of a novel human immune globulin subcutaneous, 20%: a Phase 2/3 study in Europe in patients with primary immunodeficiencies.Clinical and experimental immunology · 2017Trial
- Phase II study results of a replacement therapy for hereditary angioedema with subcutaneous C1-inhibitor concentrate.Allergy · 2015Trial
- Pharmacokinetic and pharmacodynamic relationship of AMG 811, an anti-IFN-γ IgG1 monoclonal antibody, in patients with systemic lupus erythematosus.Pharmaceutical research · 2015Trial
- A Review on Lymphatic Uptake of Large Therapeutic Proteins after Subcutaneous Injection.Pharmaceutical research · 2026Review
- PEG-RLI: A Long-Acting IL-15 Agonist That Produces Massive Levels of CD8Pharmaceutics · 2026Article
83 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The subcutaneous (SC) route is of growing interest for the administration of biotherapeutics. Key products on the biotherapeutic market such as insulins, but also several immunoglobulins or Fc-fusion proteins, are administered SC. Despite the importance of the SC route, the available knowledge about the processes involved in the SC absorption of biotherapeutics is limited. This review summarizes available information on the physiology of the SC tissue and on the pharmacokinetic processes after SC administration including "first pass catabolism" at the administration site as well as transport in the extracellular matrix of the SC tissue, followed by absorption into the blood circulation or the lymphatic system. Both monoclonal antibodies and other biotherapeutics are discussed. Determinants of absorption after SC administration are summarized including compound properties such as charge or molecular weight. Scale-up of animal data to humans is discussed, including the current shortcomings of empirical scaling approaches and the lack of suitable mechanistic approaches.
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What OpenQuestion holds
Registered trials
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.