Preclinical Product Development Services

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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:

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Drug Candidate Characterization

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• Physicochemical

• Morphological

• Biopharmaceutical

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Drug Candidate Performance Improvement

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• Enhance aqueous solubility and improve chemical stability, if needed

• Develop appropriate analytical methods to support activities

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Animal PK/tox Formulations Development

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• Dosage forms

  • Tablets​​

  • Pellets in capsules

  • Powder in capsules

  • Solution

  • Suspension

  • Microparticles

• Develop analytical methods

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FIH Formulation Development

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• Dosage forms

  • Tablets​​

  • Pellets in capsules

  • Granules in capsules

  • Powder in capsules

  • Liquid/Semisolid in capsules

  • Microparticles (dispersible)

• Develop analytical methods