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CMC Requirements for New Drug Registration in Latin America

ISPE

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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How to take care of your BIPOC patients

The Checkup by Singlecare

continues to impact BIPOC individuals and contribute to documented racial and ethnic disparities in health care. The negative outcomes for BIPOC patients are compounded by the (understandable) anxiety about and distrust for the healthcare system and its providers. A long history of medical racism in the U.S.

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Psychedelics, Pregnancy, and Breastfeeding

The Spirit Pharmacist

Beyond lack of safety data, medical approval, and regulation as illicit substances, psychedelics are powerful serotonergic compounds that have pleiotropic effects across immune, endocrine, and neural systems. J Psychoactive Drugs, 2013. Psychedelics could also have considerable risks. Neuropsychopharmacology, 2022. dos Santos, R.G.,

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Are Flame Retardant Toxins Contributing to Your Thyroid Condition?

The Thyroid Pharmacist

A few of the most common types of flame retardants include: Halogenated compounds (containing bromine and/or chlorine and known as polychlorinated biphenyls, polybrominated diphenyl ethers, etc.). The PBDEs consisted of several commercial mixtures known as octa-BDE, penta-BDE, and deca-BDE (all phased out by 2013 in the U.S.;

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Air Quality and Hashimoto’s – Is the Air You’re Breathing Making You Sick?

The Thyroid Pharmacist

I’ve seen a number of airborne toxins showing up as frequent triggers/exacerbating factors for my clients’ autoimmune conditions — mold, volatile organic compounds (VOCs), and artificial/synthetic fragrances, in particular. For cleaning products, only compounds need to be identified. Volatile Organic Compounds (VOCs) .

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Pharmaceutical microbiology: key developments 2022

European Pharmaceutical Review

He warned, “Implementation of a CCS will require more than writing documents.”. MALDI-TOF works on the basis of the ionisation of chemical compounds and measurements of their mass to charge (m/z) ratio. He questioned how regulators will enforce revisions to Good Manufacturing Practice (GMP) regulations.

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Qualification of non-mutagenic impurities (NMIs)

European Pharmaceutical Review

The document outlines alternative approaches to animal testing, including Threshold of Toxicological Concern (TTC), Quantitative Structure Activity Relationship (Q)SAR), Read Across Approaches (RAX), and in vitro approaches. Compounds that are poorly degraded or eliminated can increase concerns as they may accumulate over time.