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Charles B. Spainhour, V.M.D., Ph.D.,
DABFM, DABT |
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Expert Toxicology Consultant /
Toxicologist |
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- Consultant & Expert Witness
- Nonclinical Development Program Design & Management
- Biologics, Drugs, Devices, Nutraceuticals, Dietary Supplements
- Safety Pharmacology
- Diplomate American Board of Toxicology
- Diplomate American Board of Forensic Medicine
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Areas of Toxicology Expertise:
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- Design of Drug Discovery/Lead Optimization Programs
- Human Preclinical Pharmaceutical Development
- Biologic and Medical Device Development
- Nutraceuticals
and Dietary Supplements Safety Assessment
Programs Safety Pharmacology, Pharmacology & Toxicology
- Study Design, Monitoring and Data Analysis
- Regulatory Submission Document (IND & NDA) Preparation
and
Review
- Expert Reports
- Technical Training
- Facility
and Program Auditing
- USDA and AAALAC Inspection Preparation
- GLP Training
- Litigation Support
- Animal Rights Situation Management
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Description: |
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Doctorate in Toxicology.
Thirty-four years in Biomedical Research composed of fifteen years as
Senior Level Scientist in Major Pharma, eight years
Teaching Toxicology and Veterinary Medicine, eleven years
Directing Science and Study Conduct at a CRO. Sixteen
years as Consultant. General, Reproductive and
Developmental Toxicology and Associated ADME work. Background
Encompasses a Large Number of Test Articles in a Wide Variety of
Therapeutic Categories and Clinical Indications. Safety
Program Design and Management. Regulatory Experience |
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Contact information |
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Charles B. Spainhour V.M.D., Ph.D., DABT
Spainhour Consulting Services
27 Briarwood Way
Clarks Summit, Pennsylvania 18411
Phone: 570-586-7779
Fax:
570-586-7779
Email:
barts (at) epix.net
Website:
http://rtctox.com/spainhour.htm
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Forensic Expert Witness: |
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Willing to
serve as Expert
Witness |
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Experience
as Expert Witness |
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Dictionary of
Abbreviations and Acronyms used: |
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Aaalac |
Association for Assessment
and Accreditation of Laboratory Animal Care International |
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Adme |
Administration, Distribution,
Metabolism, and Excretion |
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Dabfm |
Diplomate of the American
Board Forensic Medicine |
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Dabt |
Diplomate of the American
Board of Toxicology |
| Cro |
Contract Research
Organization |
| Glp |
Good Laboratory Practice |
| Ind |
Investigational New Drug |
| Nda |
New Drug Application |
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Usda |
United States Department of
Agriculture |
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