| Activity examples based upon experience |
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| Consultancy |
Training |
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| 1. Preclinical programs |
1. Preclinical toxicology |
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| Design |
Toxicology principles |
| Pre-phase I package |
Definitions |
| Pre-phase II package |
Therapeutic & safety index |
| Pre-phase III package |
Acceptable daily intake |
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| Resource Planning |
PK &PD of a Toxicon |
| Test article calculation |
Exposure |
| Time planning |
ADME: Absorption, distribution, … |
| CRO selection |
Dose-response curve |
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| 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 |
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| 2. Study monitoring |
2. Clinical toxicology |
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| Planning & Protocol |
Intoxication types |
| Study planning & integration |
Acute / sub-acute / chronic intoxication |
| Protocol writing &monitoring |
Accidental / intentional intoxications |
| Compliance evaluation |
Exposition (oral, topical, parenteral … ) |
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| 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 |
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| Reporting & Interpretation |
Treatment & Prevention |
| Report writing or monitoring |
Elimination techniques |
| Report review |
Neutralization techniques & antidotes |
| Interpretation of results |
Pictograms & preventive/protective measures |
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| 3. Regulatory documents |
3. Daily exposure toxicology |
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| 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, … |
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| Scientific Support |
Contact toxins |
| Literature selection |
Body care products, including cosmetics |
| Mechanistic documentation |
Cleaning detergents and disinfectants |
| Authority consultation |
Pesticides, acids & bases, petrochemicals … |
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| Issue solving |
Inhalation toxins |
| Answers to questions |
Aromatic fragrances & other components |
| Study selection & advice |
Ingredients of dyes and wood protectors |
| Additional support |
Environmental pollutants |
Reflector Consulting provides services in chemical pharmaceutical and biomedical Research & Development. Areas of expertise are TOXICOLOGY program design, study monitoring and regulatory documentation on the one hand, and QUALITY aspects, including compliance and efficiency improvement on the other hand.