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Regulatory Perspective of Physiology based Pharmacokinetic (PBPK) Modeling

in Pharmaceutical Articles

Introduction A molecule’s journey from its discovery cradle to the patient’s bedside is highly uncertain and often has a low probability of success. Substantiation of its safety and efficacy to cater to an unmet medical need involves a long span of time and investment of billions of dollars. In order to improve the efficacy of the drug development process, various strategies are designed that aim at eliminating molecules at the earliest stages that do not promise any therapeutic benefit. For…

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Drug Tolerance

in Dictionary Online

Tolerance may be defined as either (1) the loss of effect over time to the same dose of a drug or (2) the need for more of a drug over time to get the same effect. Tolerance, at first, appears counterintuitive because addition of more of an activating ligand lessens the elicited response. [wp_ad_camp_5] Recall, however, that receptor number and receptor sensitivity are dynamic and that signaling can adjust based on the conditions of ligand availability. Given that drugs often times act…

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