USP’s featured publications include a selection of significant peer-reviewed manuscripts, articles, white papers and other materials published and presented by our staff scientists and our Expert Committees and Expert Panels. We invite you to review a sample of these materials and engage in conversations about the future of quality with us.
- Christian Zeine, Doug Podolsky, Jane Weitzel, Ravi Reddy, Steven L. Walfish. The Value of Pharmacopeial Reference Standards. Pharmaceutical Technology. February, 2021. “The US Pharmacopeia and other major pharmacopoeias have established that only the combination of documentary standards and pharmacopeial reference standards (RS) is conclusive and determines compliance to their official quality requirements. Therefore, the use of non-pharmacopeial RS with pharmacopeial methods is…more.”
- Maura C. Kibbey. Implementing Improved Analytical Methods To Support Vaccine Quality. Pharmaceutical Online. December, 2020. “Advancements in analytical technology can improve testing paradigms in vaccine development, while also supporting existing vaccine manufacturing and quality control. A key impediment to implementing new methods for characterizing and releasing licensed vaccines, however, is submitting updates to regulators across multiple jurisdictions…more.”
- Narendra Chirmule, Whitney Winters, Stephan Roenninger, Elisabeth Vachette, and Maura Kibbey. Mitigating Risks To Global Distribution Of COVID-19 Vaccines and Therapeutics. Pharmaceutical Online. December, 2020. “As of July 31, 2020, the FDA’s Coronavirus Treatment Acceleration Program had reported 570 SARS-CoV-2 drug development programs in planning stages and 270 FDA-reviewed trials. Meanwhile, the World Health Organization’s Aug. 20, 2020 draft landscape listed 30 candidate vaccines in clinical evaluation and 139 in preclinical evaluation. While these numbers illustrate the extraordinary efforts of the global community…more.”
- Fouad Atouf, Jaap Venema. Do Standards Matter? What is Their Value? Journal of Pharmaceutical Sciences. August 2020. 109(8) 2387-2392. “Standards allow us to manage expectations for a diverse range of goods and services across the globe. From coordinating international global telecommunications across 24 different time zones to ensuring access to safe drinking water, standards allow us to work… more.”
- Jingzhong Guo, Huiping Tu, B. Maheswara Rao, Anjali Kumari Chillara, Edith Chang, Fouad Atouf. More comprehensive standards for monitoring glycosylation. Analytical Biochemistry. August, 2020. 113896. “Biologics manufacturers must continually monitor the attachment of carbohydrates, called glycans, to their products, because any variability can impact safety and efficacy. To help the industry meet this challenge, the United States Pharmacopeial Convention (USP) offers glycan reference standards and validated methods for glycoprofiling…more.”
- Ian K. Warthin, Julia Berik, Doug Podolsky, Vimala Raghavendran, Ravi Reddy, Judy Chang, Noah Porter, Nicholas Garito. Commentary on the Benefits of US Pharmacopeial Standards: A Generic Pharmaceutical Industry Survey. Journal of Pharmaceutical Sciences. July, 2019. 109(2):944-949 “Pharmacopeial quality standards for medicines are associated with ensuring quality, but they can also facilitate innovation and competition in pharmaceutical markets. Unpublished data suggest that pharmacopeial quality standards, while not associated… more.”
- Scott A. Jackson, Jean L. Schoeni, Christina Vegge, Marco Pane, Buffy Stahl, Michael Bradley, Virginia S. Goldman, Pierre Burguière, John B. Atwater and Mary Ellen Sanders. Improving End-User Trust in the Quality of Commercial Probiotic Products. Frontiers in Microbiology. April, 2019. (10) 739 “In a rapidly growing global probiotic market, end-users have difficulty distinguishing between high quality and poor quality products. This ambiguity threatens the trust consumers and healthcare providers have in probiotic products. To address this problem…more.”
- Hellen A. Oketch-Rabah, Robin J. Marles, Scott A. Jordan, Tieraona Low Dog. United States Pharmacopeia Safety Review of Willow Bark. Planta Medica. November, 2019. 85(16):1192-1202. “Willow bark (Salix spp.) is an ingredient in some dietary supplements. No serious adverse effects were reported from trials of willow bark extracts delivering 120 - 240 mg salicin (the purported active constituent) daily for up to 8 weeks. All studies involved…more.”
- Chensheng Li, Sitaram Bhavaraju, Marie-Pier Thibeault, Jeremy Melanson, Andreas Blomgren, Torgny Rundlöf, Eric Kilpatrick, Carolyn J. Swann, Timothy Rudd, Yves Aubin, Kevin Grant, Margaret Butt, WaiKei Shum, Tursun Kerim, William Sherwin, Yukari Nakagawa, Sergi Pavón, Silvia Arrastia, Tim Weel, Arunima Pola, Dinesh Chalasani, Steven Walfish, Fouad Atouf. Survey of peptide quantification methods and comparison of the irreproducibility: A case study using oxytocin. Journal of Pharmaceutical and Biomedical Analysis. March, 2019. (166) 105-112. “USP’s peptide reference standards content is typically determined using an HPLC assay against an external standard for which the purity was determined by a mass balance approach. To explore the use of other analytical methods, the USP Biologics Department conducted a multi-laboratory collaborative study…more.”
- Lukas Roth, Daniel Bempong, Joseph B. Babigumira, Shabir Banoo, Emer Cooke, David Jeffreys, Lombe Kasonde, Hubert G. M. Leufkens, John C. W. Lim, Murray Lumpkin, Gugu Mahlangu, Rosanna W. Peeling, Helen Rees, Margareth Ndomondo-Sigonda, Andy Stergachis, Mike Ward and Jude Nwokike. Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regulatory systems. Globalization and Health. November, 2018. 14(1):102 “Access to quality-assured medical products improves health and save lives. However, one third of the world’s population lacks timely access to quality-assured medicines while estimates indicate that at least 10% of medicine in low- and middle-income countries (LMICs) are substandard or falsified (SF), costing approximately US$ 31 billion annually…more.”
- Qun Xu. Advancing USP compendial methods for fixed dose combinations: A case study of metoprolol tartrate and hydrochlorothiazide tablets. Journal of Pharmaceutical Analysis. April, 2019. (9) 77-82 “The current United States Pharmacopeia–National Formulary (USP–NF) includes more than 250 monographs of fixed dose combinations (FDCs), and some of them need to be updated due to incompleteness of impurity profiles and…more.”
- Annu Uppal, Chaitanya Kumar Koduri, Sireesha Yadlapalli, Narendra Chirmule, Ranjan Chakrabarti, Fouad Atouf. Recommendations for Enhancing Quality and Capability of Indian Biopharmaceutical Industry: Summary of a Workshop. Journal of Pharmaceutical Sciences. October, 2020. 109(10): 2958-2961. “The biopharmaceutical industry is undergoing an evolutionary phase with the rise of advanced manufacturing technologies. The regulatory and customer requirements are shifting towards the development of personalized or targeted medicines. With this changing landscape…more.”
Trade and professional associations
for a comprehensive list of news articles, visit our USP in the News page
- Maura Kibbey. The Right Start is Crucial. GEN – Genetic Engineering and Biotechnology News. April, 2020. “What goes into a biotherapeutic process impacts outcomes. So, raw materials and cell substrates used in biomanufacturing must be qualified for their purposes, but that creates a complicated task. To find out what causes the complication, GEN talked with Maura Kibbey, senior scientific fellow of global biologics…more.”
- John Giannone, Michael Rashed, Peter Claise, and Doug Podolsky. FDA warning letters cite drug manufacturers for failing to test excipients or verify COAs. Tablets & Capsules. October, 2019. “In 2017 and 2018, the FDA's Center for Drug Evaluation and Research (CDER) issued 38 warning letters to pharmaceutical firms in the US and 12 other countries for failing to test for identity of incoming excipients, failing to verify the information on excipient suppliers' certificates of analysis…more.”
- Steven M. Gendel. Ingredient Standards Are Vital to Supply Chain Integrity. Food Quality & Safety. September, 2019. “Maintaining food security and safety depends on protecting the integrity of the entire food supply chain. While our food has become multinational, diverse, and nonseasonal, these improvements have come with a reduction in supply chain transparency. At the same time, industry…more.”
- Will Brown, Satish Perivilli, Doug Podolsky, Erika S. Stippler, and Steven Walfish. The Critical Role of the USP Performance Verification Test in Dissolution Testing and Qualification of the Paddle Apparatus. Dissolution Technologies. February, 2019. “Performance qualification of the United States Pharmacopeia (USP) paddle apparatus (USP apparatus 2), as described in USP General Chapter <711> Dissolution, requires a demonstration of the dissolution behavior of a standard material as well as control of the mechanically measurable parameters of the apparatus. The USP performance verification test…more.”
- Parul Angrish, Rowan Moore, Jeff Rohrer, Leonel M. Santos, Shreekant Karmarkar, Edith Chang, Michael Chang, Edmond Biba. Updating the Book: Modern Methods for Modern Times. Manufacturing Chemist. January, 2018. “An accurate and good understanding of the contents of any pharmaceutical or biopharmaceutical helps to ensure both drug efficacy and patient safety. This is no revelation. In fact, this was recognised almost 200 years ago when the United States Pharmacopeia (USP) was formed…more.”
- Lawrence H. Block, Hong Wang, Catherine Sheehan. Characterization of Polymeric Excipients. Pharmaceutical Technology. April, 2017. “Viscosity, or a fluid’s resistance to flow, is independent of the rate of shear or shear stress, at a given temperature, for Newtonian fluids. Non-Newtonian fluids such as polymer solutions often exhibit viscosity values that vary with the rate of shear or shear stress. Processability and functional performance of polymeric…more.”
- Fouad Atouf. The Role of Quality Standards for Biomanufacturing Raw Materials. Pharmaceutical Technology. August, 2017. “Successful pharmaceutical manufacturing strategies depend on raw materials that are of good quality. While much effort is spent to develop active ingredient specifications, excipients and other non-active raw materials are often taken for granted…more.”
White papers and position papers
- The role of public standards in assuring the quality of digital therapeutics - As digital therapies represent an emerging science that can offer exciting alternatives for some patients, it is important to ask how the quality of these therapies can be assured.
- A Food Safety Leader’s Guide to Food Authenticity - USP white paper on the importance of food authenticity and its direct connection to food safety.
- Modernization of Organic Impurities Testing in USP Drug Product Monographs - As part of an ongoing modernization initiative, USP is updating its general chapters related to organic impurities testing for articles subject to USP–NF standards.
- Ensuring Patient Safety in Compounding of Medicines - supports a comprehensive public policy framework to advance compounding quality, promote patient safety, and respond to the evolving public health quality environment.
- Ensuring the quality of Dietary Supplements - The United States Pharmacopeial Convention (USP)4 supports a comprehensive public policy framework to ensure the quality of dietary supplements. The framework should focus on education, investment in the public agencies responsible for consumer protection, public quality standards, and surveillance.
- USP Global Public Policy Position - Combatting Substandard and Falsified Medicines USP supports a comprehensive public policy framework to combat substandard and falsified medicines, including advancing stewardship of quality pharmaceutical products and practices, and building the capacity to prevent, detect, and respond to threats.
- USP Global Public Policy Position - Combatting Antimicrobial Resistance USP supports a comprehensive public policy framework to combat AMR that focuses on reducing the threat of resistance posed by substandard medicine (one important cause) and advances stewardship of quality pharmaceutical products and practices.