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Dosage forms / Pharmacy / Tablet / Excipient / Quality by Design / Dissolution testing / Magnesium stearate / Generic drug / Formulation / Pharmaceutical industry / Pharmaceutical sciences / Pharmacology


Quality by Design for ANDAs: An Example for Immediate-Release Dosage Forms
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City

Lactose Monohydrate / magnesium stearate / /

Company

P.2 Pharmaceutical / Physical Attributes Identification Assay Content Uniformity Pharmaceutical / QTPP Elements Target Justification Pharmaceutical / /

Country

United States / /

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Event

Reorganization / FDA Phase / /

IndustryTerm

food effect / pharmaceutical quality system / pharmaceutical development / final product / drug product / generic product / proposed generic product / near expiry product / particular product / example pharmaceutical development report / degradation products / pharmaceutical development approaches / pharmaceutical development report / manufacturing process / food / /

Organization

FDA / using FDA-recommended method N/A / /

Position

levels representative / Executive / /

Product

Total tablet / Acetriptan Tablets / talc / Reference Listed Drug / Generic Acetriptan Tablets / IR tablets / QTPP Elements Target Justification Pharmaceutical equivalence Dosage form Tablet / Pilot / IR tablet / RLD tablet / Example QbD IR Tablet / Brand Acetriptan Tablets / Immediate / Nikon D90 Digital Camera / RLD tablets / Product / United States / /

Technology

Pharmacokinetics / spectroscopy / simulation / determined using UV spectroscopy / /

SocialTag