Evidence map›Paper›PMID 30357650›Full record

SynthesisClinical pharmacokinetics2019

Bridging Olaparib Capsule and Tablet Formulations Using Population Pharmacokinetic Meta-analysis in Oncology Patients.

Diansong Zhou, Jianguo Li, Khanh Bui, Maria Learoyd, Alienor Berges, Tsveta Milenkova, Nidal Al-Huniti, Helen Tomkinson, Hongmei Xu

Abstract readMeta-Analysis
PubMed Publisher
In one paragraph

Synthesis in Clinical pharmacokinetics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
–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

18 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Population pharmacokinetic analysis of danvatirsen supporting flat dosing switch.Journal of pharmacokinetics and pharmacodynamics · 2019
    Trial
  4. Article
  5. Cognitive dysfunction in chemobrain: Molecular mechanisms and therapeutic implications.Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2025
    Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Observational
  13. Review
  14. Review
  15. Article
  16. Article
  17. Therapeutic drug monitoring of oral targeted antineoplastic drugs.European journal of clinical pharmacology · 2021
    Review
  18. 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

9 authors.

Diansong ZhouQuantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, 35 Gatehouse Drive, Boston, MA, 02451, USA.
Jianguo LiQuantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, 35 Gatehouse Drive, Boston, MA, 02451, USA.
Khanh BuiQuantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, 35 Gatehouse Drive, Boston, MA, 02451, USA.
Maria LearoydQuantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Cambridge, UK.
Alienor BergesQuantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Cambridge, UK.
Tsveta MilenkovaGlobal Medicine Development, AstraZeneca, Cambridge, UK.
Nidal Al-HunitiQuantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, 35 Gatehouse Drive, Boston, MA, 02451, USA.
Helen TomkinsonQuantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Cambridge, UK.
Hongmei XuQuantitative Clinical Pharmacology, Early Clinical Development, IMED Biotech Unit, AstraZeneca, 35 Gatehouse Drive, Boston, MA, 02451, USA. xu.hongmei3@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOlaparib is a first-in-class potent oral poly(ADP-ribose) polymerase inhibitor.

objectivesThe aims of this analysis were to establish an integrated population pharmacokinetic (PK) model of olaparib in patients with solid tumors and to bridge the PK of olaparib between capsule and tablet formulations.

methodsThe population PK model was developed using plasma concentration data from 659 patients in 11 phase I, II, and III studies of olaparib tablets/capsules monotherapy. Relative bioavailability between the tablet and capsule formulations was estimated and the relative exposure between olaparib tablet and capsule therapeutic doses was further assessed.

resultsThe concentration-time profile was described using a two-compartment model with sequential zero- and first-order absorption and first-order elimination for both capsules and tablets with different absorption parameters. Multiple-dose clearance compared with single-dose clearance was reduced by approximately 15% (auto-inhibition). Disease severity had an impact on olaparib clearance, and tablet strength had an impact on K

conclusionThis analysis bridged the olaparib capsule and tablet formulation PK and provided key assessment to support the approval of the olaparib tablet formulation in patients with ovarian cancer, regardless of their BRCA mutation status.

Indexed as

Models, BiologicalAntineoplastic AgentsBiological AvailabilityCapsulesClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicFemaleHumansOvarian NeoplasmsPhthalazinesPiperazinesTabletsAntineoplastic AgentsCapsulesolaparibPhthalazinesPiperazinesTablets

Identifiers

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.