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Quality Matters

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  • Joseph Baker
  • October 31, 2014 02:02:33 AM
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A Little About Us

Official blog of US Pharmacopeia (USP), sharing unique viewpoints on the public-health impact of worldwide efforts to promote the quality and integrity of medicines, food ingredients and dietary supplements. Writers include scientists, staff, volunteer experts and representatives of USP member organizations.

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Strengthening Biotherapeutic Innovations through Emerging Analytical Tools

Strengthening Biotherapeutic Innovations through Emerging Analytical Tools Innovations in biotherapeutic medicines are advancing at an unprecedented pace and offer great promise for improving outcomes for patients. Analytical tools and approaches for understanding quality are central to fully realizing the promise these new therapies hold, and they too are quickly evolving in sophistication and precision.  Multi-attribute method (MAM) is an emerging analytical approach that is...


Q&A: Impact of Quality Medicines on AMR

Q&A: Impact of Quality Medicines on AMR Q&A with Georgetown University researchers Matthew Hassett, Ph.D. and Professor Paul Roepe, Ph.D. on their recently published review article, Origin and Spread of Evolving Artemisinin-Resistant Plasmodium falciparum Malarial Parasites in Southeast Asia. USP: What were the objectives for the review? Dr. Hassett: Our project centers on understanding the impact of quality medicines on the spread of antimicrobial resistance (AMR), particularly...


The Future is Digital: Our last printed USP–NF

The Future is Digital: Our last printed USP–NF As we approach our 200th anniversary year in 2020, I am proud to announce a major milestone in USP’s publication history, the conclusion of the USP–NF printed product. Nearly 200 years ago, a group of physicians, concerned about the quality and consistency of medicines, published the first United States Pharmacopeia (USP), which contained formulas for the preparation of 217 drugs considered to be the “most fully established...


Novel Excipients: New Hope for Therapeutic Innovations

Novel Excipients: New Hope for Therapeutic Innovations With significant innovations in pharmaceuticals, including biologic drugs and treatments for rare diseases, the need for new and better functioning excipients to improve drug delivery is growing. Under the current US regulatory system, new or novel excipients are only evaluated for intended use in the context of a drug application review.  According to the FDA, a novel excipient is one that has not been previously used in an...


Antibiotics manufacturing components can trigger adverse reactions. Standards help restore quality and trust.

Antibiotics manufacturing components can trigger adverse reactions. Standards help restore quality and trust. What happens when patients who receive a trusted treatment start experiencing adverse reactions? And what can be done to help prevent it from reoccurring? USP standards serve as part of a robust safety network that manufacturers and regulatory agencies can rely on to help ensure the quality of drug products. Recently, physicians became concerned when they saw a sharp...


A new generation of tools and standards for biologic medicine quality

A new generation of tools and standards for biologic medicine quality Patients, their families and health care providers alike care about the quality of their medicines. For nearly 200 years, USP has contributed to the quality of medicines by providing publicly-available standards. These are developed through an open and collaborative process, in which we work closely with FDA, industry and other stakeholders to develop tools that help ensure product quality and support regulatory...


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