Population pharmacokinetics and pharmacodynamics: potential use for gathering dose-concentration-response

Jerling, Markus

doi:10.1007/bf03190259

Cited by 3 publications

(1 citation statement)

References 45 publications

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“…Software tools for modelling or research. References [14,[17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] are cited in the supplementary materials.…”

Section: Supplementary Materialsmentioning

confidence: 99%

Model-Informed Precision Dosing Software Tools for Dosage Regimen Individualization: A Scoping Review

Del Valle-Moreno,

Suarez-Casillas,

Mejías-Trueba

et al. 2023

Pharmaceutics

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Background: Pharmacokinetic nomograms, equations, and software are considered the main tools available for Therapeutic Drug Monitoring (TDM). Model-informed precision dosing (MIPD) is an advanced discipline of TDM that allows dose individualization, and requires a software for knowledge integration and statistical calculations. Due to its precision and extensive applicability, the use of these software is widespread in clinical practice. However, the currently available evidence on these tools remains scarce. Objectives: To review and summarize the available evidence on MIPD software tools to facilitate its identification, evaluation, and selection by users. Methods: An electronic literature search was conducted in MEDLINE, EMBASE, OpenAIRE, and BASE before July 2022. The PRISMA-ScR was applied. The main inclusion criteria were studies focused on developing software for use in clinical practice, research, or modelling. Results: Twenty-eight software were classified as MIPD software. Ten are currently unavailable. The remaining 18 software were described in depth. It is noteworthy that all MIPD software used Bayesian statistical methods to estimate drug exposure and all provided a population model by default, except NONMEN. Conclusions: Pharmacokinetic software have become relevant tools for TDM. MIPD software have been compared, facilitating its selection for use in clinical practice. However, it would be interesting to standardize the quality and validate the software tools.

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“…Software tools for modelling or research. References [14,[17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] are cited in the supplementary materials.…”

Section: Supplementary Materialsmentioning

confidence: 99%

Model-Informed Precision Dosing Software Tools for Dosage Regimen Individualization: A Scoping Review

Del Valle-Moreno,

Suarez-Casillas,

Mejías-Trueba

et al. 2023

Pharmaceutics

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Advances in Understanding Drug Metabolism and Its Contribution to Variability in Patient Response

Tucker

2000

Therapeutic Drug Monitoring

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Recent advances in the understanding of the molecular biology and genetic variability of human drug metabolizing enzymes, particularly cytochromes P450, have contributed immensely towards clarifying the pharmacokinetics and pharmacodynamics of many existing drugs, and are increasingly important in the development of new chemical entities. However, whereas this knowledge has implications for therapeutics, appreciation and application in clinical practice have either been limited or yet to be realized. For example, the debrisoquine polymorphism was discovered 20 years ago, but controlled prospective studies to evaluate its clinical significance and pharmacoeconomic impact are few. Come the millennium it will be seen to what extent traditional therapeutic drug monitoring, involving the measurement of specific plasma drug concentrations, may be complemented or replaced by more general phenotyping or genotyping screens for human drug metabolizing enzymes.

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Therapeutic Drug Monitoring Databases for Postmarketing Surveillance of Drug-Drug Interactions

2001

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Drug-drug interactions can be associated with patient morbidity due to either increased toxicity or a potentially ineffective concentration. Because interactions cannot always be anticipated during drug development and actual patients receiving a drug for therapeutic use often differ from those included in clinical trials, postmarketing surveillance is essential. Therapeutic drug monitoring (TDM) databases offer a unique opportunity in this respect. Prerequisites for TDM databases to provide valid information in a pharmacoepidemiological perspective include the following: precise description of exposure to the potentially interacting drugs; measurement of parent compound and active metabolites through accurate and precise analytical techniques; documentation of relevant patient characteristics that may act as confounding factors (e.g. gender, age, smoking habits); repeated assessments over time if possible; and sound pharmacokinetic framework for data selection, analysis and interpretation. The contribution of TDM to the documentation of drug-drug interactions takes advantage of different possible study designs, discussed on the basis of recently published studies. The single case report plays an important role as an alert signal. It is illustrated for a patient on long-term treatment, who displayed an unexpectedly high clozapine concentration after the introduction of ciprofloxacin comedication. The prospective on and off comedication panel study shows advantages in terms of carefully selected inclusion criteria and control of treatment modalities. A study of the thioridazine-fluvoxamine interaction is presented, with patients followed on thioridazine monotherapy, after introduction of fluvoxamine and after its discontinuation. The main advantage of the retrospective large-scale TDM database screen is representativeness of patients actually treated, whereas drawbacks are related to quality of data and suitability for valid interpretation. Such an approach is illustrated by a review of data collected over 10 years of routine TDM that allowed documenting induction of nortriptyline metabolism by carbamazepine and inhibition by several phenothiazines. Finally, population pharmacokinetics is well suited to observational data collected for TDM purpose, provided quality is ascertained. Focus is placed on interindividual variability and relationship between pharmacokinetic parameters and patient characteristics, including comedication. The population approach is discussed with respect to a study that documented a 32% increase of haloperidol clearance associated with anticonvulsant comedication, in addition to effects of age and bodyweight. Among factors to consider for improved effectiveness in the use of TDM databases for postmarketing surveillance of drug-drug interactions, integration of efficacy and safety data in future studies and communication of expert recommendations to prescribing physicians are essential.

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Population pharmacokinetics and pharmacodynamics: potential use for gathering dose-concentration-response

Cited by 3 publications

References 45 publications

Model-Informed Precision Dosing Software Tools for Dosage Regimen Individualization: A Scoping Review

Model-Informed Precision Dosing Software Tools for Dosage Regimen Individualization: A Scoping Review

Advances in Understanding Drug Metabolism and Its Contribution to Variability in Patient Response

Therapeutic Drug Monitoring Databases for Postmarketing Surveillance of Drug-Drug Interactions

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