PHATOPHY - Drugs Study in Animal

- PHATOPHY recruits a Study Director for the in-life phase department

 

- PHATOPHY is Level A GLP certified since August 2010 

 

- PHATOPHY celebrates its 30 years and reported it through an article on the "Gazette du Laboratoire"

For Animal Health:

Preclinical studies in all target species
-Pharmacokinetics after treatment by IV, IM, SC, Oral, intramammary, intravaginal route, but also by spot on, pour on, bolus, intra-auricular, intranasal, intraocular, for ADME, bioavailability, dose determination, bio-equivalence, PK/PD analysis,..
-Local and systemic tolerance with examination of injection sites, gross examination in autopsy facilities, sampling for histo-pathology but also medical imaging by scan, IRM, echograph, …
-Residue depletion for any feedstuff of animal origin and dedicated to Human consumption, with validated analytical methods and in compliance with MRLs and regulatory guidelines. For milk depletion residue studies, we can work directly in regular farm without transportation of milking cows or in common farm conditions within our test facility in controlled environmental conditions…
-Palatability tests for any medicinal product given as tablets (dogs, cats) as solution or powder in drinking water or in feed (poultry, rabbits, pigs, calves,..) for short or long period of administration.
-Efficacy tests and challenge tests for antibiotics, vaccines, antiparasitic, but also for other various products that do not need regulatory studies.
-Pilot studies on target species permanently available within our associated experimental farm or other test sites, on clinically safe animals, whatever the required number, age or sex of animals.
Analytical studies
-Development and validation of analytical methods applied for the quantity determination of actives, impurities, degradation products, preservatives, manufacturing process validation, with a lot of analytical techniques with detection by fluorescence, refractometry, diode array, MS/MS
-Stability studies according to VICH conditions, at different levels of temperature and hygrometry, over 6, 12, 24, 36 and 48 months in climatic cabinets easily adaptable to any packaging form (bags, pots, flasks, blisters, boxes, ampoules, aerosols, ). Photo-stability, stability in use, stability at use by date, stability in deep freezing.
Dissolution and disintegration studies in water but also in milk, with stability studies over 12 or 24 hours, validation of medicated food process and stability studies in various conditions of storage, demixing tests, etc
Caracterisation of finished products for powder, tablets, pastes, creams, gel, solutions, suspensions, with studies of container-content effects, preservative efficiency, challenge tests.
Regulatory affairs
-Documentation research by using our own data bank but also thanks to easy access to  Universities and various High Schools or private libraries
-Writing of dossiers for registration (Marketing Authorization, MRLs), Quality part, Safety part and Efficacy part, dossiers for export (NTA or CTD format), national, centralized or mutual recognition procedures.
-Audits of dossiers, labelling, composition, indications, notices, for all kind of products