Using PBPK to Optimize Magnesium Concentrations in an Intravenous Formulation
A new intravenous formulation was developed and the client wanted to know if Allucent could help evaluate the proposed magnesium amount in the new formulation considering various populations of pregnant women, neonates, infants, pediatric patients, adults, and adults with renal impairments. Download the full case study below to learn more. DOWNLOAD RESOURCE
Using PBPK to Extrapolate Animal Tissue Concentrations to Humans
An approved small molecule therapeutic has shown efficacy in numerous target organs of interest in clinical trials. The client wished to show that this efficacy was explained by high drug penetration into these tissues. PBPK modeling can be utilized in multiple stages of drug development. New guidance from regulatory agencies has highlighted key areas for […]
Using Modeling and Simulation to Determine FIH Dose
Allucent’s client requested assistance using modeling and simulation to determine the First-in-Human(FIH) dose for their program. The drug was created to prevent the toxicity of cytotoxic drugs. However, the sponsor felt that the drug could be studied in healthy volunteers in Phase 1, if given carefully and for a short period. Conducting a Phase 1 […]
Gene Therapy
Allucent’s client requested support to bring an AAV gene therapy for a rare neurodegenerative disease into the clinic for a Phase 1b study in patients. Dosescaling from pharmacology and toxicology studies by brain volume alone for administration directly into the brain by MRI-Guided Convection-EnhancedDelivery led to human equivalent doses that lacked a margin of safety. […]
Due Diligence to Support a Client’s Decision-Making
A client needed due diligence performed on the preclinical data, translational dose rationale and first-in-human (FIH) clinical protocol for a central nervous system (CNS) small molecule indicated for a chronic neurodegenerative orphan disease. Download the full case study below to learn more. DOWNLOAD RESOURCE
Complex Concentration-QT Analysis
A Concentration-QT (C-QT) Analysis is a modeling and simulation technique used to help establish the risk of prolonging the QT interval. C-QT analysis can sometimes eliminate the need for a TQT study, which is more expensive and time-consuming. In a C-QT analysis, pharmacokinetic data (concentration of a drug over time) is time matched with EKG […]
Grass & Birch Allergy Phase II Parallel Studies
About the Case Study Pharm-Olam was contracted to provide a full-service solution for two Phase II, dose escalation allergy studies that required a total of 500 patients in Europe and were run in parallel. With two different indications required, Grass Pollen Allergy and Birch Pollen Allergy, Pharm-Olam completed a comprehensive feasibility program and presented the […]
Indolent NHL Immuno-Oncology Rescue Study
Background Non-Hodgkin’s Lymphoma (Indolent NHL, PI3K inhibitor) Allucent was contracted to provide rescue study services by a small-emerging biotech company after the originally contracted CRO had difficultly enrolling patients in the challenging indication of refractory, indolent NHL (Follicular Lymphoma, Marginal Zone Lymphoma, or Small Lymphocytic Lymphoma), as well as other quality issues. Allucent set up […]