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Drug development stages of PMx service projects (2016-2019). The purposes are divided into 7 different subcategories.
Source publication
As the pharmaceutical industry in Korea is reaching the golden era of drug discovery due to increased investments in research and development and government funds, the need for a more efficient tool for the quantitative analysis has emerged. Therefore, the demand for pharmacometrics (PMx) consultancy services increased. Higher quality service suita...
Context in source publication
Context 1
... next was phase 1 to phase 1 prediction (~28%), including next dose prediction within SAD study, MAD prediction from SAD study, and different population PK prediction within phase 1 study, followed by NCA, which was separately grouped but mainly involved phase 1 data. Others were non-clinical PK prediction from nonclinical data, phase 1 to phase 2 prediction, and PK prediction within phase 3 studies, which predicted a racial difference in PK. Figure 3 shows the proportion of 7 different subcategories of drug development stages of PMx service projects. A yearover-year trend of drug development stages is outlined in Figure 4. ...
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Empirical pharmacometric models are part of practically every regulatory submission for a new drug. The use of the models often exceeds descriptory roles and this change in their context of use increase the requirements on the evidence to support that they are credible. However, when it comes to assessing the trust in a model for a specific applica...
Citations
In the last 4 years, pharmacometrics (PMX) has advanced to the point that it is now a crucial part of drug development. Drug delivery systems and molecules with more complex architecture are being developed as technology advances. Pharmacodynamic modelling is based on the quantitative integration of pharmacokinetics, pharmacological systems, and (patho-) physiological processes in order to comprehend the intensity and time course of drug effects on the body. As a result, the drug absorption and disposition processes after the administration of these drug delivery systems and engineered molecules become exceedingly complex. The research field of drug delivery focuses on the development of new techniques to manipulate drug absorption and disposition to achieve a desirable effect for the PMX model used. An opportunity to combine pharmacokinetic and pharmacodynamic model-based estimations with pharmacoeconomic models emerges given the unpredictability in the dose-concentration-effect relationship of medications. Model-based drug development (MBDD) has been found to address the underlying causes of medication failure, hence enhancing the productivity, effectiveness, and success of late-stage clinical research. The pharmacokinetic (PK) model principles in optimizing the drug dose to suit individual patient needs and achieving maximum therapeutic utility are called clinical pharmacology. Pharmacodynamics (PD) relates response to the concentration of drugs in the body. Disease progression model-based evaluation of disease progression is an important aspect of drug development and pharmacology. The future perspective of pharmacometrics in drug development and clinical practices is challenging.
