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Contribution of Population-Pharmacokinetics to Drug Development Essay Example

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Contribution of Population-Pharmacokinetics to Drug Development

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Contribution of Population-Pharmacokinetics to Drug Development. Meanwhile, Hsieh and Korfmacher (2006) noted that where intensive blood sampling is possible, there is the benefit of replicating the outcomes with particular blood samples for a larger population size. This means that where intensive blood sampling is not possible an alternative is needed to ensure that almost all populations are catered for. Typical situations in drug development where intensive blood sampling has not been attainable include drug development processes for children, cancer and AIDS patients (Baaske, Wienken, Reineck, Duhr and Braun, 2010). There is a typical example with a study by the US Food and Drug Administration for AIDS patients where instead of using intensive blood sampling in the drug development process, pharmacokinetic screening was rather employed at phase II and phase III of the study (Greenberg, 2000).

In a similar study by the Medicines and Healthcare Products Regulatory Agency in UK where the target population was cancer patients, using pharmacokinetic screening did not only proof useful in attaining important clinical information but also was seen to be a generally cost-effective approach to get such information pertaining to both pharmacokinetic and pharmacodynamic variability in treated patients (Ruiz-Garcia, Bermejo, Moss and Casabo, 2008). One other major contribution of population pk to drug development is the ability to base on outcomes with population pk studies to customize pharmacotherapy. In a study by Raymond and Brasseur (2005), it was found that there are several factors that make this outcome with customized pharmacology possible. In the first place, population pk requires that multiple samples from one person are not used. In effect, variability in drug concentrations is achieved for very specific patient populations (Bonate, 2005). This way, it is possible to assign differences in pharmacokinetics to specific patient characteristics and hence customization of pharmacotherapy. In the second instance, it is seen that when population pk is used, it is possible to emphasize on subgroups of populations. . Contribution of Population-Pharmacokinetics to Drug Development.

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References

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