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P < ("P Less Than" Company) provides consulting services to life science companies:
Pharmacometric, Pharmacokinetic, Pharmacodynamic, and Statistical Analyses- Pharmacometrics: Analysis of in-progress or completed clinical trials, focussing on effect size and robustness of multiple outcomes rather than hypothesis testing.
- Pharmacokinetic modeling: Mixed-effects (NONMEM) methods analysis of routine or complicated pharmacokinetic clinical/preclinical issues such as linear vs. nonlinear absorption, saturable elimination, metabolite kinetics, sparse data
- Pharmacodynamic modeling: Development and analysis of pharmacodynamic models (both direct and indirect) to develop dosing strategies and to evaluate success of clinical trials.
- Regression models, other statistics: Linear, non-linear, and logistic regression analysis of sparse data, unbalanced samples, or missing data, using mixed-effects approaches when appropriate.
- Clinical trial simulation: Development of dosing and sampling regimens for clinical trials based on available preclinical and clinical data. Simulation of outcomes of clinical trials to evaluate trial design.
- Clinical and Regulatory Guidance
- Preparation of IND's, including determination and justification of "first dose in humans"
- Design of early- and late-stage clinical trials (with a particular expertise in proof-of-concept trials)
- Working with FDA on behalf of sponsors
- Preparing and reviewing clinical study reports and regulatory documents
- Forensic Pharmacometrics
- Post hoc analyses of failed phase 2 and phase 3 programs
- Goal is to determine if a different dosing regimen would increase the likelihood of success in a new clinical trial
- Due Diligence
- Assisting both investors and pharma companies with inlicensing, outlicensing, and early-stage investing
- Software to Facilitate Conduct of NONMEM Analyses
- Software to provide a complete environment for the conduct of NONMEM analyses is available from PLTsoft.com.
- Software to create NONMEM datasets from source documents (sas7bdat, SAS XPT, XLS, XLSX, CSV, etc.) is available from PLTsoft.com.
- NONMEM Training
- Steven Shafer and I conducted NONMEM training courses for 14 years. None are scheduled at present.
NEWS: P Less Than is pleased to announce partnering with Scott Brittain.
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