WebMay 5, 2024 · Development of generic single-entity drug-device combination products for orally inhaled drug products (OIDPs) is challenging, due in part to the complex nature of device design characteristics, and to the difficulties associated with establishing bioequivalence (BE) for a locally-acting drug product delivered to the site of action in the … WebNIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Notice of Correction to Funds Available and Award Budget for RFA-FD-12-019 Predictive Lung Deposition Models for Safety and Efficacy of Orally Inhaled Drug Products (U01) NOT-FD-12 …
Scientific Publications by FDA Staff - Food and Drug …
WebMar 12, 2015 · The presentations at the Orlando Inhalation Conference on pharmacokinetic (PK) studies indicated that PK is the most sensitive methodology for detecting formulation differences of oral inhaled drug products (OIDPs) that have negligible gastrointestinal bioavailability or for which oral absorption can be prevented (e.g., ingestion of charcoal). WebConsulting services: CMC Technical Project Leadership, Advisory, On-demand training. Specialties: Respiratory Drug Product Development, Formulation, Orally inhaled and nasal drug product (OINDPs), Combination product, Dry Powder (DPI) and Soft Mist (SMI) Inhalation, Spray drying, Biologics, Small molecules. Contact: … biotechnology personalized medicine
Center for Research on Complex Generics (CRCG) on LinkedIn: #oidps …
WebFeb 3, 2024 · FDA recommendations for establishing bioequivalence (BE) with local drug delivery for orally inhaled drug products (OIDPs) often involve study designs for conducting comparative clinical... WebMar 31, 2024 · Orally Inhaled and Nasal Drug Products (OINDPs) are of growing importance in the pharmaceutical domain, owing to their intrinsic benefits over the traditional dosage forms, such as low first pass effect by hepatic metabolization, fast onset action, and high drug levels in brain tissue (nasal route) and lung (oral inhalation).Moreover, OINDPs can … biotechnology personal statement igem