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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

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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 2006. The fit-for-purpose and reduced-size POD units promote green manufacturing. Journal of Biotechnology 213 (2015):120–30.

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The Benefits of Vitamin D for Your Thyroid

The Thyroid Pharmacist

10] In Finland, the incidence of type 1 diabetes in Finnish children increased when the daily recommended dosage of vitamin D was reduced from 4000-5000 IU in 1964, to 400 IU in 1992. Yet, incidences of diabetes in children have been decreasing since 2006, the year Finland decided to fortify all dietary milk products with vitamin D3.

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How Do Adaptogenic Herbs Benefit Hashimoto’s?

The Thyroid Pharmacist

I recommend that you closely monitor your thyroid symptoms, thyroid hormones, and thyroid antibodies, and test hormone levels every six to 12 weeks, to ensure your thyroid medication dosage is optimized. 2006 Feb 16;78(12):1287-92. You are pregnant or nursing: Most adaptogens are not to be taken during pregnancy. Int J Ayurveda Res.