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Salvaging CNS Clinical Trials Halted Due to COVID‐19

The coronavirus disease 2019 (COVID‐19) pandemic has halted many ongoing central nervous system (CNS) clinical trials, especially in Alzheimer’s disease. These long‐duration trials involve many stakeholders, especially the patients and their family members, who have demonstrated their commitment to developing new therapeutic interventions for this devastating disease. We certainly do not want to lose all … Continued

Mechanistic quantitative pharmacology strategies for the early clinical development of bispecific antibodies in oncology

Bispecific antibodies (bsAbs) have become an integral component of the therapeutic research strategy to treat cancer. In addition to clinically validated immune cell re‐targeting, bsAbs are being designed for tumor targeting and as dual immune modulators. Explorative preclinical and emerging clinical data indicate potential for enhanced efficacy and reduced systemic toxicity. However, bsAbs are a … Continued

Trial Simulator for NONMEM Modelers

Examples Guide Version 1 Applies to: Trial Simulator 2.3, NONMEM 7.3 As a courtesy to Certara’s Trial Simulator users, we have created this guide with 23 hypothetical examples where NONMEM codes and the corresponding TS codes are provided so that users may use these examples as templates to enter their models into Trial Simulator for … Continued

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