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The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Camargo

The first two were published in December of 2014: Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act mandates that NDAs, ANDAs, and INDs be submitted in electronic format. 3.1.1: Bioavailability Study Reports. 3.1.1: Bioavailability Study Reports.

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Synthesis-to-Clinic®: integrating isotopic labeling and human ADME to reduce time to clinic

Pharmaceutical Technology

Understanding how a drug will act in the body, including how it is absorbed, distributed, and eventually eliminated, is a crucial component of drug research. ADME studies require the use of a radiolabeled version of the investigational drug. ADME studies require the use of a radiolabeled version of the investigational drug.

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ProstaStream

The Pharma Data

The natural green tea contained by this formula, and the broccoli leaf extracts are also powerful ingredients. But even so, I decided to do something never before seen: And the good news keep on coming: So click the 6-bottle package or any other package you choose below this video right now to secure your order.

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Accurate dosing: How to achieve maximum precision with poor-flowing products

Pharmaceutical Technology

Due to rising healthcare spending, launch of novel treatments, and the rise of chronic diseases in an aging population, the global pharmaceutical packaging equipment market is rapidly expanding. But cost-effectiveness in drug-loading and production speed relies on dosing accuracy. Recent analysis valued the market [i] at USD 8.5

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Mitigating the risks of cross-contamination during Oral Solid Dose (OSD) manufacturing

Pharmaceutical Technology

In 2021, 72% of newly approved drugs were small molecules, and almost 50% of new drugs approved were OSD. While the industry is seeing advances in alternative drug delivery systems, oral solid doses, such as pills, capsules and soft gels, remain at the forefront of the industry.