Therapeutic Areas in Which Projections Research has Experience
a. PRI has experience working with pharmacokinetics and pharmacodynamics of anti-hypertensive agents, cholesterol lowering agents and anti-coagulants.
b. Such agents are frequently dose adaptively based on measured endpoints (e.g. blood pressure). PRI has extensive experience in conducting adaptive simulations to evaluate the performance of pharmacodynamic models and also to evaluate clinical trial designs.
c. PRI has experience with models of disease progression for recovery from stroke as well as models for time to event for assessing protective ability of drugs designed to prevent stroke and heart attack
a. PRI has experience (primarily with biological agents) developed for treatment of RA, psoriasis, UC/IBD. PRI has developed pharmacokinetic and pharmacodynamic models for such agents in support of dose regimens
a. PRI has experience in developing models to select or support dose regimens for novel antibiotic agents.
b. PRI has experience with antiviral agents for treatment of HIV (e.g. enfuvirtide) and Hepatitis (e.g. interferon, Entecavir). PRI has worked with models for viral load/viral DNA to evaluate drug activity.
4. Anti-neoplastic agents
a. PRI has extensive experience with anti-neoplastic agents (both biological and chemical agents). PRI has developed models for both pharmacokinetics and pharmacodynamic responses (latter is primarily adverse event response although we have developed models for survival with selected agents such as paclitaxel).
a. PRI has experience working with drugs designed to treat major depressive disorder, Alzheimer’s disease, schizophrenia and mania and epilepsy. In many cases, models for disease progression for these agents have been developed. In particular PRI has developed and published models for placebo effects which can be substantial in this therapeutic area.
b. PRI has experience also with sedative/hypnotics such as midazolam, diltiazem, propofol etc.
Other Areas in Which Projections Research has Experience
a. PRI has experience in providing support for pediatric extensions for marketed agents.
2. PK/QTc evaluations
a. PRI has extensive experience in conducting PK/QTc evaluations.
3. Formulation changes
a. PRI has assisted companies that are changing formulations (e.g. changing an immediate release to a sustained release) by developing PKPD models to support the use of the new formulation at the requested dose
4. Disease progression modeling
a. PRI has experience in developing models for disease progression for many therapeutic indications (e.g. treatment of osteoporosis etc).
a. PRI has experience in providing dose adjustments for obese subjects. In addition to the changes in body mass and composition, adipose tissue produces cytokines making dosing for anti-inflammatory agents somewhat different in this patient population.