Technical Writing Services with a Clinical Pharmacology Focus
Allucent has extensive experience with clinical pharmacology studies and analyses needed to support drug development programs and messaging of key data to support the product label. Our authoring tasks span the entire process from drafting, reviewing, and updating to full writing of regulatory documents, supporting clients with documents that meet industry standards in an efficient […]
Study Design and Conduct Leveraging Allucent’s Clinical Pharmacology Expertise
Allucent has extensive experience with designing, conducting, analyzing, and interpreting of data from each type of Phase 1 clinical pharmacology study needed for an individual drug development program. While we can conduct any Phase 1 study, our focus and expertise in clinical pharmacology is our differentiator. This is about much more than just conducting one […]
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. […]
Rare Central Nervous System Disease Trials
Precision medicine offers the promise to treat a variety of conditions, especially rare diseases, with targeted approaches. But developing more personalized medicines can introduce new complexities in the clinical trial process, which can hold back drug developers on the road to commercialization. Find out the factors that make rare neurological diseases a prime target for precision […]