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Pill Identification

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