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Program
Tuesday, 7 September 2010
MULTIPARTICLE DOSAGE FORM
08.30 Transfer from hotel to TTC
08.45 Login
09.00 Introduction
Klaus Either
09.10 Pellets as oral multi particulate
Mike Newton
dosage
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What is multiparticle dosage forms?
Multiparticle dosage forms are pharmaceutical dosage forms composed of multiple particles, each containing a portion of the drug substance.
Who is required to file multiparticle dosage forms?
Pharmaceutical companies and manufacturers are typically required to file multiparticle dosage forms for regulatory approval.
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Multiparticle dosage forms can be filled out by providing detailed information on the composition, manufacturing process, and intended use of the dosage form.
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The purpose of multiparticle dosage forms is to provide a controlled release of the drug substance, allowing for better absorption and efficacy.
What information must be reported on multiparticle dosage forms?
Information such as the drug substance(s) used, particle size distribution, coating material, release profile, and stability data must be reported on multiparticle dosage forms.
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