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. At this stage of development there are often more questions than answers.

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?