Regulatory Toxicology Perspectives on the Development of Botanical Drug Products in the United States

2004 ◽  
Vol 11 (3) ◽  
pp. 213-217 ◽  
Author(s):  
Kuei-Meng Wu ◽  
James Farrelly ◽  
Debra Birnkrant ◽  
Shaw Chen ◽  
Jinhui Dou ◽  
...  
Keyword(s):  
United States ◽  
The United States ◽  
Regulatory Toxicology ◽  
Drug Products ◽  
Botanical Drug

A update of botanical drug development in the United States: Status of applications

Planta Medica ◽  
2015 ◽  
Vol 81 (11) ◽  
Author(s):  
KM Wu ◽  
C Wu ◽  
J Dou ◽  
H Ghantous ◽  
S Lee ◽  
...  
Keyword(s):  
United States ◽  
Drug Development ◽  
The United States ◽  
Botanical Drug

The use of the United States FDA programs as a strategy to advance the development of drug products for neglected tropical diseases

2014 ◽  
Vol 40 (11) ◽  
pp. 1429-1434 ◽  
Author(s):  
Kristina Sachs-Barrable ◽  
Jocelyn Conway ◽  
Pavel Gershkovich ◽  
Fady Ibrahim ◽  
Kishor M. Wasan
Keyword(s):  
United States ◽  
Neglected Tropical Diseases ◽  
The United States ◽  
Tropical Diseases ◽  
Drug Products

scholarly journals Analysis of Crowdsourced Metformin Tablets from Individuals Reveals Widespread Contamination with N-Nitrosodimethylamine (NDMA) in the United States

2020 ◽  
Author(s):  
Qian Wu ◽  
Evgenia Kvitko ◽  
Amber Jessop ◽  
Shannon Williams ◽  
Ryan C. Costantino ◽  
...  
Keyword(s):  
United States ◽  
High Resolution Mass Spectrometry ◽  
Daily Intake ◽  
The United States ◽  
Product Recalls ◽  
Acceptable Daily Intake ◽  
Drug Products ◽  
Post Market ◽  
United States Food ◽  
States Food

AbstractRecent reports of metformin drug products contaminated with unacceptable levels of the probable human carcinogen N-Nitrosodimethylamine (NDMA) prompted a national sampling of post-market metformin drug products. To most broadly sample the market and minimize supply chain bias, metformin medication samples were crowdsourced directly from individuals across many states in the United States. 128 samples were received, and liquid chromatography-high resolution mass spectrometry tests for a panel of nitrosamines revealed significant levels of NDMA that trend with labeling company. 42% of all medication samples contained detectable levels of NDMA and, when scaled to maximum daily tablet dose, 36% of all medication samples contained NDMA levels exceeding the FDA daily acceptable intake limit. The highest NDMA detection from the tested samples was 1565 ng per tablet, which, when commonly taken four times a day, is 65 times the United States Food and Drug Administration (FDA) acceptable daily intake limit. Results underscore the need for immediate product recalls of tainted medications and an overall investigation of metformin manufacturing practices.

How Often are Orphan Drugs Orphaned by the Thermochemical Community?

2020 ◽  
Vol 27 (1) ◽  
pp. 23-31 ◽  
Author(s):  
Kathleen F. Edwards ◽  
Joel F. Liebman
Keyword(s):  
United States ◽  
Metabolic Disease ◽  
Orphan Drug ◽  
Drug Product ◽  
Orphan Drugs ◽  
The United States ◽  
Drug Products ◽  
Chemical Structures ◽  
Disease Condition ◽  
The U.S

Orphan drug products (e.g. drugs and biologics) in the United States are those that treat people with rare chronic diseases, often cancer or metabolic disease. The rare disease condition being treated by these orphan drugs must serve a patient population of less than 200,000 people in the U.S. in order to earn the orphan drug product title. Just as the disease conditions are seen as “orphans,” so, we assert is the thermochemical understanding of the drugs themselves in terms of the chemical structures that define those drugs. This article illustrates this orphan thermochemical status for a recent series of orphan drugs.

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