Preclinical Product Development Services
Targeted development services that expeditiously facilitate preclinical animal PK/tox studies and first-in-human (FIH) trials using limited API quantities and fit-for-purpose formulations comprising:
Drug Candidate Characterization
-
Physicochemical
-
Morphological
-
Biopharmaceutical
Drug Candidate Performance Improvement
-
Enhance aqueous solubility and improve chemical stability, if needed
-
Develop appropriate analytical methods to support activities
Animal PK/tox Formulations Development
-
Dosage forms
-
Tablets
-
Pellets in capsules
-
Powder in capsules
-
Solution
-
Suspension
-
Microparticles
-
-
Develop analytical methods
FIH Formulation Development
-
Dosage forms
-
Tablets
-
Pellets in capsules
-
Granules in capsules
-
Powder in capsules
-
Liquid/Semisolid in capsules
-
Microparticles (dispersible)
-
-
Develop analytical methods