About this Research Topic

Background

Drug therapy success is highly dependent on the choice of the drug and the dosage regimens. The drug choice is predominantly made by the physician after patient diagnosis and physical assessment. The choice of the drug product and dosage regimen is based on the patient's individual characteristics and the known pharmacokinetics of the drug. Ideally, the dosage regimen is designed to achieve the appropriate drug concentration at a receptor site to produce an optimal therapeutic response with minimum adverse effects. Individual variation in pharmacokinetics (PK) and pharmacodynamics (PD) makes the correct dosage regimen difficult to determine. During drug discovery, PK/PD models can be used to identify and select the best drug candidates, predict clinical response in humans, and facilitate a better understanding of the potential clinical relevance of a drug. These models can also facilitate characterizing the mechanism of action and disease behavior of a given drug aiding in assessing efficacy and safety.

Clinical pharmacokinetics aims to predict the best dosage and dosing regimen to ensure and maintain therapeutically effective concentrations at the site of action. Clinical pharmacokinetics includes the quantitative study of the physiological processes of absorption, distribution, metabolism, and excretion. Fundamental physiochemical properties (e.g. lipophilicity, pKa, and solubility), PK properties (e.g. permeability, protein binding, and clearance) and PK modeling approaches (e.g. physiologically based PK, empirical and population-based PK) of drugs are investigated as part of clinical pharmacokinetics. It describes how these processes play a critical, often decision-making role in the discovery and development of new chemical entities as prospective drugs. It also describes qualitative and quantitative aspects of these processes in a pragmatic style. Finally, applications of the aforementioned PK principles during different stages of drug discovery and development provide detail on drug efficacy and safety, thereby helping to decide upon optimal doses and schedules in patients, and how to adapt doses in clinical settings for patients with various demographic and disease characteristics (e.g. ethnicity, age, presence of food and/or co-medications). Outcomes of clinical pharmacokinetic studies are useful for determining the appropriate use of medicines according to patient characteristics, such as disease and genotype of drug-metabolizing enzymes, and for predicting the influence of pharmacokinetic drug interactions. The results can also provide information for therapeutic drug monitoring (TDM). It is important to evaluate pharmacokinetic parameters of individual subjects (patients or healthy volunteers) in close association with observed drug efficacy and adverse drug reactions.

We welcome original research and review articles covering, but not limited to, the following areas:

• Clinical pharmacokinetics in the formulation development of pharmaceutical dosage forms.

• Preclinical studies to investigate the toxicity of drug candidates and establish their potency in animal and human models.

• Dose-response relationship, bioavailability, and tissue distribution studies.

• Pharmacological assays for the prediction of in-vivo efficacy.

• Pharmacokinetic profiling in drug analysis and drug stability.

• Pharmacokinetic-pharmacodynamics relationship evaluation.

• Bio-analytical methods for the determination of pharmacokinetic parameters.

• Therapeutic drug monitoring (TDM), drug-drug interactions, bioequivalence, drug metabolism, drug efficacy and safety studies.

Keywords: Implication, Clinical, Pharmacokinetics, Drug Development, Clinical Research, Translational.

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