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Does the Drug Shortage White Paper Fall Short?

FDA Law Blog: Biosimilars

FDA previously analyzed 163 drugs that went into shortage in the 5-year period between 2013 and 2017; 63% (103) were sterile injectables and 67% (109) were drugs that have a generic version on the market. For generic drug manufacturing facilities specifically, the numbers are 63% and 87%.

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ACMT Toxicology Visual Pearl: Swollen Lips

ALiEM - Pharm Pearls

The severity and extent of symptoms depend on the concentration, dosage, and form of caustic ingested. 2013 Jul 7;19(25):3918-30. Long-term complications in survivors may include gastrointestinal strictures, stenoses, and fistula formation. What diagnostic testing should be obtained? BMC Gastroenterol. 2008 Jul 25;8:31.

Dosage 130
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The Missing Link to Thyroid Fatigue

The Thyroid Pharmacist

Please note: Some people may need to increase their dosage of thiamine from 600 mg per day. It looked at the effect of thiamine on patients with Crohn’s disease and ulcerative colitis, and found that effective dosages ranged from 600 mg to 1,500 per day, depending on individual body size. [7] 2013 Aug;19(8):704-8. doi:10.1046/j.1432-1327.2001.02329.x.

Dosage 98
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UNC team discovers interactions vital for hepatitis A virus replication

Pharmaceutical Technology

In 2013, UNC Department of Medicine and UNC Department of Microbiology & Immunology professor Stanley Lemon and colleagues discovered that the HAV undergoes significant changes within the human liver. The latest findings are the first to show that a drug was effective against HAV in an animal model of the disease.

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Staging of Renal Function

RX Note

NOTE: While creatinine is commonly utilized, it is not perfect as creatinine is a metabolic by-product of muscle catabolism, meaning patients with lower or higher than average muscle will demonstrate different values than expected based on their renal function.

Dosage 52
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Paradigm Shift in Drug Development: Analytical Quality by Design and Analytical Procedure Life Cycle

Quality Matters

and increased complexity of the manufacturing process Traditional medicines have been evolving into more complex, sophisticated drug products, dosage forms, and advanced therapies. Some highlights include: USP created an Expert Panel in 2013 to focus on the future of analytical validation concepts.

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Chronic Kidney Disease

RX Note

NOTE: While creatinine is commonly utilized, it is not perfect as creatinine is a metabolic by-product of muscle catabolism, meaning patients with lower or higher than average muscle will demonstrate different values than expected based on their renal function.