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Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

ISPE

In 2014, CDER established the Emerging Technology Program (ETP) within its Office of Pharmaceutical Quality to better facilitate the adoption of emerging technologies such as CM. End-to-end continuous processes flow from starting materials to finished dosage forms.

FDA 52
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Lasers for Thyroid Tissue Regeneration

The Thyroid Pharmacist

2] In some cases, the person will become hyperthyroid, and the dosage of their medications will need to be reduced. If they are already taking thyroid medications, they may find themselves overmedicated, and may need to work with their doctors to reduce their dosage of thyroid medications. References [1] Nanan R, Wall JR. Ross, DS.

Dosage 97
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Strategies to Overcome Anxiety with Hashimoto’s

The Thyroid Pharmacist

You may want to read my articles on understanding your thyroid labs and taking thyroid medications for more information on how adjusting thyroid medication dosages can help optimize your thyroid hormone levels. Presented as part of the Anxiety Summit; June 22, 2014. [16] Published 2017 Sep 26. doi:10.3389/fpsyg.2017.01668

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms.” September 2014. 4 (2014):771–83. The fit-for-purpose and reduced-size POD units promote green manufacturing. doi:10.1016/j.jbiotec.2015.06.388

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2.

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2.

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A Systemwide Approach to Managing the Risks of Continuous Manufacturing

ISPE

For much of the pharmaceutical industry, batch manufacturing (BM) processes that have been relied upon for decades remain the preferred approach for most oral solid dosage (OSD) drug products. 176 (September 2014):54517–49. This document catalogs and summarizes the various risks to the company. Final Rule. Washington, D.C.: