RTCTox Research & Technology Center in Toxicology

Pill Identification

Alex Apostolou, DVM, PhD

Expert Toxicology Consultant / Toxicologist
	Drug Research & Development, and Regulatory Support International Litigation Arbitration Product Safety
Areas of Toxicology Expertise:
	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
Description:
	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).
Contact information
	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
Forensic Expert Witness:
	Willing to serve as Expert Witness
	Experience as Expert Witness

Dictionary of Abbreviations and Acronyms used:
Ctd	Comparative Toxic genomics Database
eCTD	Electronic Comparative Toxic genomics Database
Fda	Food and Drug Administration
Glp	Good Laboratory Practice
Ich	International Conference on Harmonization
Ind	Investigational New Drug (Exemption)
Nda	New Drug Application
Nada	New Animal Drug Application

Pharmikos

Pharmikos