Services

Dennis Miller of CPTxBio provides advice and assistance on the planning, design and interpretation of a number of activities that are critical to the early drug development phase.

Clinical Pharmacology services:
-Protocol planning and study design
-Statistical analysis plans
-Data interpretation and reporting
-Bioanalytical support of PK, biomarker and immunogenicity assays

Preclinical services:
-Toxicology study planning, conduct, interpretation and reporting
-Pharmacokinetic study planning, interpretation and reporting
-Bioanalytical assay planning, establishment, validation and conduct

I also can intergrate and link the various preclinical activies to each other and to clinical trial activites.

Another way to view my services is in terms of the questions and uncertainities that exist during early drug development.

Example questions that I can help to answer:
-What doses should I use in a pharmacology study?
-How does an effective dose in a disease model relate to the clinical situation?
-What concentration should my drug be for clinical testing?
-How much drug do I need to make for the next phase of development?
-How much drug is expected in the blood of a patient following dosing?
-What type of PK assay do I need?
-How sensitive does it need to be?
-What does it need to detect?
-What types of immunogenicity assays do I need?
-What does it need to detect?
-What is the significance of a finding in a toxicology study?
-How do I use a biomarker to predict effective dose(s) for my drug?
-How do I combine my drug with another drug, device, or therapy?