Clinical Pharmacology
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Focusing on scientific basis of Drug use, Development and Evaluation, ClinPharm stretches from pre-clinical pharmacology through PKPD into therapeutics with each segment adding value to the next.
We understand the complexity in bridging pharmacological response to Clinical measures of efficacy influenced by trial design, pharmacokinetics, formulation characteristics and clinical variability.
Our Clinical Pharmacology expertise effectively bridges the gap between Science and Practice of Medicine, enhances the Population response relationships with clincial adverse events, Biomarkers and Clinial Response.
We create Assessments, Solutions and Strategies for various Drug Development needs relying on our pool of real-life experimental biology, pharmacokinetic, clinical and Modeling expertise.
Dose Selection and Extrapolation
Translation of Dose from Animal to human
Dose decisions based on clinical data
Dose selection for large scale trials
Model based dose extrapolations to various sub-populations
Pediatric
Geriatric
Renal or Hepatic impaired
Evaluate clinical data to assess key exposure relationships.
- Exposure vs. Safety
- Exposre vs. biomarkers
- Exsure vs. clinical response
Assessing Drug Response as a population effectIntrinsic and extrinsic factors and their relationshipsDrug characteristics vs. Clinical Response Formualtion effectInter-occassion variabilityDrug Reponse in various Sub populations : Pediatric, Geriatric, Renal or Hepatic impaired
Our strong expertise in Clinical Pharmacoogy aplied to clinical research
- Trial designs based on established safety as well as simulated human exposures, Drug MOA and effect size.
- Patient section and Criteria
- Dose selection for Phase II and III trials
- Special Studies : Renal, Hepatic, Radiolabeled, Pediatric Investigation plans
- Biowaivers
At Pleroo Research, we have provided clinical pharmacology support to our clients over the last decade, providing critical data analysis, regulatory strategy, modeling and simulation as well as design of trials. We present you technically sound, cross functional and business relevant solutions without restricting to closed eco-systems or software platforms.
Solutions matter!
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