| Vincent B. Ciofalo, Ph.D. | | |
| | | |
| Expert Toxicology Consultant / Toxicologist |
| | - Preclinical Development Program Design & Monitoring
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| Areas of Toxicology Expertise: |
| | - New Drug Research & Development Design & Management
- Drug Metabolism
- Pharmacokinetics
- Toxicology & Clinical Study Design
- Monitoring & Evaluation;
- Regulatory Affairs (GLP, GCP, cGMP, IND, NDA)
- Assist Pharmaceutical Business & Trade in China
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| Description: |
| | 7 years Quality Control Management; Over 15 years in directing New Drug Research & Development; Over 10 years as part-time Consultant; 10 years as Adjunct Professor of Pharmacology & Toxicology. Diplomate, American Board of Forensic Examiners & American Board of Forensic Medicine |
| Contact information: |
| | Vincent B. Ciofalo The Summit Group P.O. Box 756 Waverly, Pennsylvania 18471 Phone: (570) 586-4193 Fax: (570) 585-8990 e-mail: vbc (at) epix.net Website:http://rtctox.com/ciofalo.htm | |
| Forensic Expert Witness: |
| | Willing to serve as Expert Witness | |
| | Experience as Expert Witness | |
| | |
| Dictionary of Abbreviations and Acronyms used: |
| Glp | Good Laboratory Practice | |
| Gcp | Good Clinical Practice |
| cGMP | Current Good Manufacturing Practice | |
| Ind | Investigational New Drug (Exemption) | |
| Nda | New Drug Application | |