Dose Translation, Rationale, and Justification

Establishing the appropriate dosing regimens is critical to maximizing safety and efficacy for patients and clinical trial participants. Allucent’s pharmacologists and pharmacometricians are experts in dose translation, selection, and justification across all therapeutic areas, modalities, and stages of development.

Allucent partners with your team to build strategies and models tailored to guide your program’s dosing decisions. Even before your drug reaches the clinic, nonclinical modeling and simulation approaches are used to predict human PK and dose based on desired PD (safety and efficacy targets or outcomes) to inform candidate selection, formulation selection, other nonclinical studies, and establish an appropriate first-in-human (FIH) starting dose and dose range.

Allucent’s pharmacometricians use modeling techniques to explore and/or evaluate how different dosing choices (e.g., dose amount, frequency, and duration) and patient variability affect drug concentrations and the relationships between drug concentration and desired or undesired responses to select appropriate doses for clinical trials, specific populations, and indications, as appropriate, for regulatory authority review.

Dose Translation, Rationale, and Justification Services:

• Calculating the clinical dose to inform:
  • candidate selection, product profile, therapeutic index, formulation selection, drug supply, cost of goods, dose range for toxicology studies, assay development, and drug-drug interaction potential
• Translating in vitro, non-clinical PK/PD data, and published controlled clinical study results to clinical dose strategies
  • i.e., starting dose, dose escalations, dose cohorts, proof of concept and dose-ranging study designs, drug-drug interaction studies, etc. /li>
• Optimizing dose and dose frequency for specific populations
  • infants, children, pregnant and breast-feeding women, elderly, patients with renal or hepatic impairment, and more
• Providing comprehensive justification of the clinical dose(s) for indications, diverse patient characteristics, and various clinical scenarios for regulatory authority review