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Alex Apostolou, DVM, PhD |
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Expert Toxicology Consultant /
Toxicologist |
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- Drug Research & Development, and
Regulatory Support
- International Litigation Arbitration
- Product Safety
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Areas of Toxicology Expertise:
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- Drug Safety
and Efficacy (USA & ICH Compliance)
- Regulatory
Strategy; Preparation and Support of IND/NDA/NADA
Sections, Investigators' Brochure, Introduction Statements, Annual Reports. Carcinogenicity
& Risk Assessment. Ophthalmologic & Dermatological
Products
- Food Safety
- Good Laboratory Practice (GLP) Compliance and
Inspection
- Litigation/Arbitration
Support
- Preparation of
Chemical Toxicology Profiles. Evaluation of
Licensing Candidates
- Literature
Search and Analysis
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Description: |
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1965-1991: Drug
Industry (16 yrs.); Contract Laboratories (4 yrs); FDA
(6 yrs); Former Director of Toxicology (FDA). Director Dept.
of Pharmacology / Toxicology (Bristol-Myers). Research Fellow (Merck).
Chairman, Committees for Cancer Assessment (FDA), Product Recalls
(FDA), and Animal Welfare. USA Representative at the Codex Alimentations.
Since 1991: Senior Toxicology/Pharmacology Consultant for the
Domestic and Foreign Drug and Chemical Industries and the U.S. Government,
Medical Database Contractor (National Library of Medicine). |
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Contact information |
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Alex Apostolou,
DVM, PhD
5308 Bangor Drive
Kensington, Maryland 20895-1105
Phone: (301)929-6263
Home Page: http://www.altox.com
Email:altox
(at) altox.com
Website:http://rtctox.com/apostolou.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: |
| Ctd |
Comparative Toxic genomics Database |
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| eCTD |
Electronic Comparative Toxic genomics Database |
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Fda |
Food and Drug Administration |
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Glp |
Good Laboratory Practice |
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| Ich |
International Conference
on Harmonization |
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| Ind |
Investigational New Drug (Exemption) |
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Nda |
New Drug Application |
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Nada |
New Animal Drug Application |
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