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Formulation Technology and
Development including: |
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Solutions |
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Encapsulation and taste masking
technologies with or
without slow release profiles |
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Liposomes |
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Nano-suspensions |
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Nanocapsules |
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Nano-emulsions |
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Lyophilisates |
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Powders for dual chamber systems
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Drugs not stable in an aqueous
formulation |
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Methods Development and
Characterization of formulations
with respect to pH, osmolarity (isotonicity),
viscosity, surface tension,
refractive index and zeta potential,
differential calorimetry |
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Analytical Methods Development
for drug assay and impurities by GC
and HPLC fitted with a variety of
detectors, such as UV, PDA,
Fluorescence, ELSD, MS-MS |
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Stability Testing of
formulations at various conditions
according to FDA and ICH Guidelines |
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Particle Size Measurements of
formulations via laser diffraction
(Malvern) and cascade impaction (ACI,
NGI) or cast models such as the
Sophia Anatomical Infant Nose Throat
(SAINT) model |
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Aerosol Characterization of
formulations under breath simulation
that mimic real breathing patterns
of patients. In-vitro data to
determine in-vivo results |
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Comprehensive Method Validation |
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Preparation of Pharmaceutical
Development Reports |
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Regulatory and Clinical Trial
Support |
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Project Management to Keep Your
Product Development on Track
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Resources Through Network Partners
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Characterization of formulations in
epithelial and alveolar
cell culture models for the assessment of their tolerability
and pharmacokinetics |
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Scale-up of batches including
manufacture of clinical trial
and production batches |
