Comparative extractable studies for injectables and medical devices aligned with USP <1663> and ISO 10993 guidelines
Download the whitepaper to learn more about the regulatory requirements that must be considered when designing an extractable and leachable study.
A deep understanding of the most recent regulatory guidelines is very important to give drug product-specific recommendations for an appropriate study design for extractable studies for pharmaceutical packaging, drug delivery systems, and medical devices. Read the whitepaper for an in-depth analysis of regulatory frameworks and methodologies for extractable and leachable (E&L) studies. It compares study designs based on USP <1663> and ISO 10993 guidelines, emphasizing chemical characterization and risk management for drug packaging and medical devices.
The article was initially published in OndrugDelivery in 2021.
A deep understanding of the most recent regulatory guidelines is very important to give drug product-specific recommendations for an appropriate study design for extractable studies for pharmaceutical packaging, drug delivery systems, and medical devices. Read the whitepaper for an in-depth analysis of regulatory frameworks and methodologies for extractable and leachable (E&L) studies. It compares study designs based on USP <1663> and ISO 10993 guidelines, emphasizing chemical characterization and risk management for drug packaging and medical devices.
The article was initially published in OndrugDelivery in 2021.
