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Navigating the unique CMC challenges of oral anaerobic live biotherapeutics

European Pharmaceutical Review

As previously highlighted batch-to-batch variability in potency is expected, however, the compounding effect of method related variability in quantification makes root cause analysis even more difficult when trying to identify those parameters/conditions for process establishment/scale up. 2015; 69(1):381–403 5. 2021; 19:100306 4.

Dosage 77
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14 remedies to get rid of congestion

The Checkup by Singlecare

Follow these steps to try nasal irrigation for congestion: Prepare the nasal rinse solution by mixing saline with distilled water per the package instructions. Supplement with turmeric Curcumin is the main compound of the herb turmeric, and according to Dr. Garcia-Ibáñez, it works as a powerful antioxidant and anti-inflammatory.

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Contamination Trends & Proposed Solutions

ISPE

The cases covered the same types of contaminants and impurities noted in Table 1: microbial contaminants, process-related im-purities, metal contaminants, packaging-related contaminants, drug cross-contamination, and an “unknown” category encompassing other contaminants associated with the manufacturing process, including those from cell culturing.

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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.

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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. Thymoquinone (TQ), one of the active compounds found in black seed oil, acts as a biofilm disruptor, meaning that it can break free from the protective coating that H. 39,64-67).

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). These new operating models can help enable and accelerate the efforts of Pharma 4.0™