Preclinical Consulting for Pharmaceuticals & Medical Devices
Kathleen P. Baran, Ph.D., D.A.B.T.
Knowledge and Experience
With more than 30 years of experience working in the pharmaceutical and medical device industries, I have the experience necessary to move projects forward efficiently, on time, and according to your budget. I have a breadth of knowledge that includes the areas of toxicology, pharmacology, safety pharmacology, pharmacokinetics, and medical device materials biocompatibility evaluation. I understand what is needed to support the various stages of development.
Communicating Results
I believe communication is one of the key factors to your program's success and coordinate all the interactions between the client, the research organizations conducting the preclinical work, and myself. You also receive a clear explanation of the meaning of the results of testing or the contents of a risk assessment.
Services
My company, TOX-TK Associates, L.L.C. in Lady Lake, Florida, was founded in 2004 and offers the following:
• Design & Management of Pharmaceutical
Preclinical Testing (ICH International
Guidelines)
• Pharmacokinetic (PK) Study Design, Data
Analysis (WinNonlin™), & Reporting
• Use of Quality Proven Preclinical CROs |
• Interpretation & Integration of
Preclinical Safety Data
• Assistance with Due Diligence
• Monitoring Preclinical Studies
• Review of Preclinical Data |
• Representation at Regulatory Meetings
• Preparation of the Preclinical Portions of
Regulatory Submissions
• Medical Device Materials Biocompatibility
Evaluation (ISO 10993)
|
Learn More About Kathleen P. Baran
