Population Modeling Capabilities

Population pharmacokinetic, PK/PD, and exposure-response modeling are the industry standard approaches for modeling clinical, and increasingly non-clinical, pharmacological and safety and efficacy data to inform clinical trial program design and data analysis and interpretation. This meets regulatory requirements and expectations through all drug development phases to submission and beyond. Population PK, or PK/PD modeling uses […]

Model-Informed Drug Development

Let your data be your guide. With model-informed drug development (MIDD), you can leverage your existing data and others to optimize your pre-clinical and clinical studies and development programs. Allucent has an expert team of pharmacometricians and modelers with state-of-the-art high-performance computing (AWS) to help you design, simulate and analyze your drug development studies and […]

Begin with the End in Mind Investigational New Drug (IND) Services

The IND application is the primary means through which the FDA allows the testing of new drugs and biologics in humans. The path to a successful IND can be long and resource intensive. The first key to success is understanding the IND process and how to best support your clinical program. Clinical Pharmacology Modeling and […]

Allucent’s Expertise in Predicting Human Exposure From Nonclinical Data

Several different approaches can be used to predict human drug exposures and exposure-response relationships from nonclinical data. Four possible approaches are described below. Scope and budget for actual project requests may differ, depending on specific client objectives, (including which and how many dosing regimens to simulate) and the amount and format of the nonclinical data […]

505(b)(2) Regulatory Pathway – Clinical Pharmacology Services

Understanding how to link the two products best is an essential step in maximizing the full streamlining capability of the 505(b)(2) approach and requires experts in these techniques to be successful. Allucent can help with your program’s505(b)(2) strategy by helping create the strongest PK (and sometimes PK/PD) modeling and development plans needed for your 505(b)(2)program. […]

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