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Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Pharmaceutical Technology

Understanding both the significant competitive advantages that FDC products can offer, and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Of those 131 approved FDCs, 98 were oral dosage forms.

Dosage 52
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EMA Annex 1 Q&A discusses bioburden considerations

European Pharmaceutical Review

In its answer, when considering bioburden, EMA shared that the specification limits should be “NMT 10 CFU/100ml”, in line with the guideline sterilisation-medicinal-product and active-substance ref EMA/CHMP/CVMP/QWP/850374/2015. What are the requirements for the bioburden sampling to support parametric release?

Dosage 52
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Are microtaggants the key to making medicines smarter?

pharmaphorum

Many countries have introduced serialisation legislation which requires product identifiers to be affixed to each package to provide traceability throughout the distribution supply chain. However, traceability and security measures focused on the packaging level may not be enough to protect patients. About the author .

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Hashimoto’s and Graves’ Remission after Helicobacter Pylori Eradication

The Thyroid Pharmacist

In 2015, 80 percent of my clients who hit a plateau with nutrition and took the gut tests I recommended, tested positive for at least one gut infection. MegaGuard and PyloGuard provide doses on the package. doi: 10.1515/cipms-2015-0038. Published 2015 Jul 16. Gut Infections and Autoimmunity. 39,64-67). 2018; 28(1): 30-32.

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Navigating the unique CMC challenges of oral anaerobic live biotherapeutics

European Pharmaceutical Review

Intestinal bacteria ( microbiome ) concept Capsules are therefore the most common dosage form considered currently for LBP delivery due to their flexibility in selection of size during dose establishment and the ability to modify release profiles using well established coating systems. 2015; 69(1):381–403 5. 2021; 19:100306 4.

Dosage 97
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Studies on Magnesium and Thyroid Health

The Thyroid Pharmacist

11] For insomnia : I like to recommend Epsom salt baths (one cup of salts per tub – follow package instructions, and don’t overdo it!), link] Published May 11, 2015.; doi:10.1139/cjpp-2015-0247.; You may also want to explore gut issues that may be a trigger, including SIBO , parasites , and food sensitivities. [11] Lundberg M.

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Sleep Solutions for Hashimoto’s

The Thyroid Pharmacist

Be sure to follow the package directions and your practitioner’s guidance to determine the right dosage for you. 2015-1351 [3] Rasch B, Born J. doi:10.1155/2015/607148 [16] Thakkar MM. 2015;8(3):143-152. doi:10.1016/j.slsci.2015.09.002; 2015.09.002; Wondisford FE. Endocrinology. 2015;156(6):1939-1940. doi:10.1210/en.2015-1351