RTCTox Research & Technology Center in Toxicology

Pill Identification

Darcy G. Perkins, Ph.D.

Expert Toxicology Consultant / Toxicologist
	Non-Clinical Drug Development Toxicology Programs IND and NDA Pharmaceutical Development Project Planning/Management Regulatory Affairs Preclinical Study Monitoring Diplomate, American Board of Toxicology
Areas of Toxicology Expertise:
	Preclinical Pharmaceutical Development Drug Development Strategies and Guidance for Non-Clinical Toxicology and ADME Strategies for Conventional Design and Analysis of Preclinical Studies Preparation of Quality Submissions including IND/NDA, CTX/ MAA, and Expert Reports Review of License Candidates Evaluation of Unexpected Scientific and Regulatory Issues Clinical Investigator Brochures Preparation of Regulatory Documents for Submission Product/Project Management Toxicology and Product Safety Assessment Protocol Design (GLP and Non-GLP) Preclinical Study Placement and Monitoring GLP Facility Audits (in-house or CRO) Data Auditing Report Review and Preparation Study Summary Tables Preparation of Toxicology Submissions (IND, CTD, NDA) for FDA and International Agencies Literature Reviews and White Papers
Description:
	Doctorate in Toxicology; 24 years experience with Scientific Management Responsibilities with Major Pharmaceutical Companies involving General, Toxicology, Reproductive, and Inhalation Toxicology; associated drug ADME Expertise; Experienced in a Variety of Therapeutic Categories; Project Planning and Management, Technical and Scientific Management in Toxicology Laboratories; Publications; Regulatory Experience. More than 20 years with major pharmaceutical companies
Contact information
	Darcy G. Perkins, Ph.D. TriPharmSafety, Inc. Consultants in Pharmaceutical Toxicology P.O. Box 91386 Raleigh, North Carolina 27675 Phone: (919) 870-5772 Fax: (919) 870-4417 Home Page: http://www.tripharmsafety.com Email: dperkins (at) tripharmsafety.com Website: http://rtctox.com/perkins.htm
Forensic Expert Witness:
	Not willing to serve as Expert Witness	No
	No experience as Expert Witness	No

Dictionary of Abbreviations and Acronyms used:
Adme	Administration, Distribution, Metabolism, and Excretion
Ctd	Comparative Toxicogenomics Database
Cro	Contract Research Organization
Ctx	Clinical Trials Exemption
Fda	Food and Drug Administration
Glp	Good Laboratory Procedure
Ind	Investigational New Drug (Application)
Maa	Marketing Authorization Application
Nda	New Drug Application

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