Veterinary Medicines Data
Animal health products are often developed from active substances that are already registered for other applications, e.g. as human medicines or pesticides. Therefore most studies are already available. It is recommended to review the available data package before the start of a testing program.
The "Quality Package" requires the following studies and information:
• Certificates of analysis for starting materials, intermediates, active substances and fomulated products, all with validated methods
• Stability testing under controlled climate conditions for the active substance, all products and all primary packaging materials
The "Safety Package" includes:
• Pharmacology (dynamics, kinetics)
• Toxicology: single and repeated dose, tolerance in target species, reproductive toxicity
• User safety: irritation, percutaneous and inhalation toxicity, sensitisation, etc.
• Ecotoxicology with exposure estimations and experimental tests
The "Residue Package" is only required when the product is used on food producing animals. The package consists of:
• Metabolism studies with C-14 labeled substances
• Depletion of residue studies
• Validated analytical methods for residue monitoring in food
The "Efficacy Package" includes clinical studies with the target species under controlled field conditions. These studies follow a similar scheme to the one known from human drug development during phases I to III. Particular emphasis concerns the monitoring of resistance development.
LKC Switzerland Ltd offers the following services to the Animal Health Industry:
• Preparation of Marketing Authorisation Applications (MAA), Drug Master Files (DMF) and other regulatory documents
• Preparation of expert reports and risk assessments, especially for the chemical/pharmaceutical and toxicological summaries
• Project monitoring, with the advantage that we are independend of the CROs and capable to audit test facilities and studies on behalf of the sponsor as required by GLP/GMP
People at LKC Switzerland Ltd have special expertise in insecticides, parasiticides and other pesticide related products.
Related Information
Contact LKC
LKC Switzerland Ltd
Hauptstrasse 10
P.O. Box 167
4414 Füllinsdorf
Switzerland
Phone: +41 (61) 906 8500
Fax: +41 (61) 906 8509