Pharmacokinetic-pharmacodynamic analysis' role in design of phase Ⅰ clinical trials of anticoagulant agents: a systematic review.

Pharmacokinetic-pharmacodynamic analysis' role in design of phase Ⅰ clinical trials of anticoagulant agents: a systematic review. Expert Rev Clin Pharmacol. 2020 Oct 07;: Authors: Zhao N, Xiang Q, Liu Z, Zhao X, Cui Y Abstract INTRODUCTION: There remains an unmet need for better anticoagulants. The phase I clinical trial is of great significance in the development of anticoagulants, and the design is special. This system review aims to provide insights for the design of future phase I clinical trials of anticoagulants. AREAS COVERED: We searched the database PubMed and ClinicalTrail.gov website, to collate the phase I clinical trial of anticoagulants in healthy people. The study protocol, inclusion exclusion criteria, safety and pharmacodynamic indexes were reviewed. EXPERT COMMENTARY: New anticoagulants under development focused on inhibiting one or more than one serine proteases within the coagulation cascade. Agents targeting intrinsic factors are in the pipeline of the drug development. The enrollment eligibility criteria have more restrictions on laboratory tests, medical history, or medication history related to bleeding and coagulation; more precautions were taken to assess and minimize the risk of hemorrhagic events. Pharmacodynamics markers were evaluated as a surrogate marker of anticoagulation potency to guide further dose selection in drug's development. In future, the positive control study can be appli...
Source: Expert Review of Clinical Pharmacology - Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research