Andre Raw
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View article: Optimizing the detection of N-nitrosamine mutagenicity in the Ames test
Optimizing the detection of N-nitrosamine mutagenicity in the Ames test Open
View article: Effect of Antioxidants in Medicinal Products on Intestinal Drug Transporters
Effect of Antioxidants in Medicinal Products on Intestinal Drug Transporters Open
The presence of mutagenic and carcinogenic N-nitrosamine impurities in medicinal products poses a safety risk. While incorporating antioxidants in formulations is a potential mitigation strategy, concerns arise regarding their interference…
View article: FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications
FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications Open
This paper describes a new FDA's pharmaceutical quality assessment system: Knowledge-aided Assessment & Structured Application (KASA). The KASA system is designed to: 1) capture and manage knowledge during the lifecycle of a drug product; …
View article: Building parity between brand and generic peptide products: Regulatory and scientific considerations for quality of synthetic peptides
Building parity between brand and generic peptide products: Regulatory and scientific considerations for quality of synthetic peptides Open
View article: Erratum to: Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products
Erratum to: Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products Open
View article: Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference
Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference Open