ReviewActa pharmacologica Sinica2012
Clinical pharmacology considerations in biologics development.
Review in Acta pharmacologica Sinica, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 2 of them syntheses that pooled 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.
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
66 citing papers in PubMed, 2 syntheses or guidelines pooled it, 119 citations in OpenAlex.
- The impact of hepatic and renal function on panitumumab exposures in patients with metastatic RAS wild-type colorectal cancer.Cancer chemotherapy and pharmacology · 2021Pooled it
- Determination of the starting dose in the first-in-human clinical trials with monoclonal antibodies: a systematic review of papers published between 1990 and 2013.Drug design, development and therapy · 2016Pooled it
- A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-07261271 in healthy participants.British journal of clinical pharmacology · 2026Trial
- A Phase 1 first-in-human study of the safety, tolerability, and pharmacokinetics of the ROBO2 fusion protein PF-06730512 in healthy participants.Pharmacology research & perspectives · 2021Trial
- Population Pharmacokinetic Modeling of Olaratumab, an Anti-PDGFRα Human Monoclonal Antibody, in Patients with Advanced and/or Metastatic Cancer.Clinical pharmacokinetics · 2018Trial
- Blinatumomab, a Bispecific T-cell Engager (BiTE(®)) for CD-19 Targeted Cancer Immunotherapy: Clinical Pharmacology and Its Implications.Clinical pharmacokinetics · 2016Trial
- A thorough QT study to assess the effects of tbo-filgrastim on cardiac repolarization in healthy subjects.Drug design, development and therapy · 2015Trial
- Developmental Progress and Future Potential for Inhaled Biologics in the Treatment of Respiratory Diseases.Drugs · 2026Review
- Pharmacological principles of intravitreal drug therapy and their implications for clinical practice: a primer for the ophthalmologist.Eye (London, England) · 2026Review
- Drawing a line in the sand: impact of analytical choices on anti-drug antibody cut-points and testing outcomes.Bioanalysis · 2026Article
- Safe Handling and Clinical Administration of Antibody Drug Conjugates: Occupational Safety, Material Compatibility, and the Integration of CSTDs into Workflows.AAPS PharmSciTech · 2026Review
- De-risking Biopharma Asset Acquisition: Towards a Quantitative Framework for Strategic Decision-making.The AAPS journal · 2026Review
- Pharmacological considerations for next-generation protein therapeutics in cardiovascular disease.The Journal of pharmacology and experimental therapeutics · 2025Review
- How does mathematical modeling improve our understanding and design of biological immunomodulators?Therapeutic delivery · 2025Article
- Accelerating Biologics PBPK Modelling with Automated Model Building: A Tutorial.Pharmaceutics · 2025Review
- Clinical pharmacology-how it shapes the drug development journey.European journal of clinical pharmacology · 2025Review
- Pharmacokinetics of Nivolumab and Erythropoietin in a Rat Model of Diet-Induced Obesity.Pharmaceutical research · 2025Article
- Uncovering the interleukin-12 pharmacokinetic desensitization mechanism and its consequences with mathematical modeling.CPT: pharmacometrics & systems pharmacology · 2025Article
- Macrophage metabolism in inflammatory heart disease: new insights and therapeutic implications.Frontiers in medicine · 2025Review
- A review of dose escalation for FDA-approved products treating solid tumors and hematological malignancies in first-in-human trials.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024Review
6 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 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Biologics, including monoclonal antibodies (mAbs) and other therapeutic proteins such as cytokines and growth hormones, have unique characteristics compared to small molecules. This paper starts from an overview of the pharmacokinetics (PK) of biologics from a mechanistic perspective, the determination of a starting dose for first-in-human (FIH) studies, and dosing regimen optimisation for phase II/III clinical trials. Subsequently, typical clinical pharmacology issues along the corresponding pathways for biologics development are summarised, including drug-drug interactions, QTc prolongation, immunogenicity, and studies in specific populations. The relationships between the molecular structure of biologics, their pharmacokinetic and pharmacodynamic characteristics, and the corresponding clinical pharmacology strategies are summarised and depicted in a schematic diagram.
Indexed as
Identifiers
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.