ReviewClinical pharmacokinetics2008
Pharmacokinetic and pharmacodynamic data to be derived from early-phase drug development: designing informative human pharmacology studies.
Review in Clinical pharmacokinetics, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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
11 citing papers in PubMed.
- A Triterpenoid Lupeol as an Antioxidant and Anti-Neuroinflammatory Agent: Impacts on Oxidative Stress in Alzheimer's Disease.Nutrients · 2023Review
- Recent developments inDrug metabolism reviews · 2021Article
- Generating Robust and Informative NonclinicalAntimicrobial agents and chemotherapy · 2019Review
- Pharmacological vs. classical approaches in the design of first in man clinical drug trials.British journal of clinical pharmacology · 2017Article
- Rethinking risk assessment for emerging technology first-in-human trials.Medicine, health care, and philosophy · 2016Article
- Translational pharmacokinetic-pharmacodynamic modeling from nonclinical to clinical development: a case study of anticancer drug, crizotinib.The AAPS journal · 2013Article
- Modeling and simulation at the interface of nonclinical and early clinical drug development.CPT: pharmacometrics & systems pharmacology · 2013Article
- Systems pharmacology: bridging systems biology and pharmacokinetics-pharmacodynamics (PKPD) in drug discovery and development.Pharmaceutical research · 2011Article
- Developing drug prototypes: pharmacology replaces safety and tolerability?Nature reviews. Drug discovery · 2010Review
- Risk assessment in extrapolation of pharmacokinetics from preclinical data to humans.Clinical pharmacokinetics · 2010Article
- PK/PD modelling and beyond: impact on drug development.Pharmaceutical research · 2008Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Drug development is, in essence, the answering of scientific questions related to the effects of the intended new medicine. This process starts with preclinical research and proceeds with clinical testing. Especially for innovative drugs, this proceeds along a number of cycles in which the questions are answered by learning from informative studies and subsequent confirmation in more pragmatic studies. Many first-in-human studies and other human pharmacology studies are not designed to be informative but use standard designs and answer generic questions about tolerability and safety. Despite several recent and eloquent pleas for more integrated and quantitative drug development, signs of a strong uptake of this are lacking. In this article, an orderly method for the determination of objective human pharmacology studies is given. The objectives of the study and the expected pharmacology and pharmacokinetics of the compound determine the optimal design; and several general design models and guidelines are given for the design of informative human pharmacology studies.
Indexed as
Identifiers
18479172What 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.