Lawrence X. Yu
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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: A network of regulatory innovations to improve FDA quality assessments of human drug applications
A network of regulatory innovations to improve FDA quality assessments of human drug applications Open
A network of regulatory innovations brings a holistic approach to improving the submission, assessment, and lifecycle management of pharmaceutical quality information in the U.S. This dedicated effort in the FDA's Center for Drug Evaluatio…
View article: Industry 4.0 for pharmaceutical manufacturing: Preparing for the smart factories of the future
Industry 4.0 for pharmaceutical manufacturing: Preparing for the smart factories of the future Open
Over the last two centuries, medicines have evolved from crude herbal and botanical preparations into more complex manufacturing of sophisticated drug products and dosage forms. Along with the evolution of medicines, the manufacturing prac…
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: A multiple biomarker assay for quality assessment of botanical drugs using a versatile microfluidic chip
A multiple biomarker assay for quality assessment of botanical drugs using a versatile microfluidic chip Open
View article: Understanding Pharmaceutical Quality by Design
Understanding Pharmaceutical Quality by Design Open
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: Advancing Product Quality: a Summary of the Second FDA/PQRI Conference
Advancing Product Quality: a Summary of the Second FDA/PQRI Conference 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: Gordon L. Amidon: Very Sustained Drug Absorption
Gordon L. Amidon: Very Sustained Drug Absorption Open
View article: Erratum to: A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion
Erratum to: A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion 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
View article: A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion
A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion Open
View article: Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production
Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production Open
View article: International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences
International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences Open
View article: Dissolution Testing for Bioavailability of Over-the-Counter (OTC) Drugs—a Technical Note
Dissolution Testing for Bioavailability of Over-the-Counter (OTC) Drugs—a Technical Note Open