Activity examples based upon experience
Consultancy Training
1. Preclinical programs 1. Preclinical toxicology
Design Toxicology principles
Pre-phase I package Definitions
Pre-phase II package Therapeutic & safety index
Pre-phase III package Acceptable daily intake
Resource Planning PK &PD of a Toxicon
Test article calculation Exposure
Time planning ADME: Absorption, distribution,
CRO selection Dose-response curve
Test Facility/Site Selection Toxicology studies
Comparison of cost &service General& specific toxicology studies
Facility, process &procedure evaluation Parameters & criteria in toxicology studies
Multi-site situation analysis Safety assessment & extrapolation to man
2. Study monitoring 2. Clinical toxicology
Planning & Protocol Intoxication types
Study planning & integration Acute / sub-acute / chronic intoxication
Protocol writing &monitoring Accidental / intentional intoxications
Compliance evaluation Exposition (oral, topical, parenteral )
Follow-up &Documentation Prevalence & Causes
Scientific & compliance monitoring Age & location distribution
Amendment & deviation management Causes & examples of intoxication
Raw data sampling & composition Diagnosis samples & techniques
Reporting & Interpretation Treatment & Prevention
Report writing or monitoring Elimination techniques
Report review Neutralization techniques & antidotes
Interpretation of results Pictograms & preventive/protective measures
3. Regulatory documents 3. Daily exposure toxicology
Dossier Preparation Food toxins
Safety documents Natural toxins in plants, animals & food
Clinical trial applications Food contaminants, e.g. additives, toxins
Common technical documents Leisure consumables , e.g. caffeine,
Scientific Support Contact toxins
Literature selection Body care products, including cosmetics
Mechanistic documentation Cleaning detergents and disinfectants
Authority consultation Pesticides, acids & bases, petrochemicals
Issue solving Inhalation toxins
Answers to questions Aromatic fragrances & other components
Study selection & advice Ingredients of dyes and wood protectors
Additional support Environmental pollutants