Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US
| Autor: | Michael Kopcha, Lucinda F. Buhse, Adam C. Fisher, Janet Woodcock, Richard L. Friedman, Melika Ashtiani, Alex Viehmann |
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| Rok vydání: | 2020 |
| Předmět: |
Quality Control
Prescription drug Quality management Research media_common.quotation_subject Capsules General Medicine Quality Improvement United States Dosage form Product (business) Online Only Pharmaceutical Preparations Generic drug Drugs Generic Quality (business) Process performance index Business Marketing Medical prescription Original Investigation Pharmacy and Clinical Pharmacology Tablets media_common |
| Zdroj: | JAMA Network Open |
| ISSN: | 2574-3805 |
| DOI: | 10.1001/jamanetworkopen.2020.13920 |
| Popis: | Key Points Question Are there substantive differences in the major quality attributes of difficult-to-make pharmaceutical products manufactured throughout the world and marketed in the US? Findings In this quality improvement study, all of 252 drug product samples met the US market standards for the major quality attributes of dosage unit uniformity and dissolution, although there was evidence of differences in the consistency of these attributes among regions and manufacturers. Meaning These findings suggest that difficult-to-make prescription pharmaceuticals marketed in the US consistently meet quality standards even when manufactured outside the US. This quality improvement study examines quality testing of prescription pharmaceutical products that are manufactured in various regions of the world and marketed in the US. Importance Health care practitioners and patients must have information to support their confidence in the quality of prescription pharmaceuticals. Objective To determine whether there were clear and substantive differences in major quality attributes between difficult-to-make solid oral dosage form pharmaceutical products marketed in the US. Design, Setting, and Participants This quality improvement study analyzed US Food and Drug Administration–collected samples of 252 drug products marketed in the US and manufactured in the US, Canada, Europe, India, and the rest of Asia. These drug products were immediate-release solid oral dosage forms considered difficult to make on the basis of product quality history. This sampling included 35 innovator and 217 generic drug samples manufactured by 46 different firms containing 17 different active ingredients. Statistical analysis was performed from February to November 2019. Main Outcomes and Measures All products were tested within their shelf life on the basis of the legally recognized tests of the US Pharmacopeia for the major quality attributes of dosage unit uniformity and dissolution. These tests measure dosage consistency and drug release, respectively. The consistency of either attribute was used to calculate a process performance index to describe the variability in manufacturing. Results All 252 drug product samples met the US market standards for dosage unit uniformity and dissolution, although the process performance index (Ppk) for dissolution fell below the level of 4-sigma capability (ie |
| Databáze: | OpenAIRE |
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