by Steven Perez | Jul 7, 2011 | Analytical Testing News & Updates | ADPEN Laboratories, Pharmaceutical Links
This past May, FDA issued a new guidance for industry concerning the submission of summary bioequivalence data for abbreviated new drug applications (ANDAs). The guidance is meant to clarify the requirements for the submission of bioequivalence data that were...
by Steven Perez | Jul 7, 2011 | Analytical Testing News & Updates | ADPEN Laboratories, Nutraceutical Links
The FDA issued its updated draft guidance on new dietary ingredients (NDIs), which the agency said is intended to assist industry in deciding when a premarket safety notification for a dietary supplement containing a NDI is necessary. The guidance is also designed to...
by Steven Perez | May 26, 2010 | Analytical Testing News & Updates | ADPEN Laboratories, Food Safety Links
Nitrofurans are a class of drugs that have the ability to kill micro-organisms. The group consists of four drugs. Since 1989, nitrofurazone has been discontinued from being classified as a drug by the US Food and Drug Administration. It has been reported that most...
by Steven Perez | May 26, 2010 | Analytical Testing News & Updates | ADPEN Laboratories, Food Safety Links
In September 2008, China found that milk powder, milk, yogurt and infant formula had been adulterated (contaminated) with melamine. Nearly 53,000 illnesses, over 12,800 hospitalizations and several infant deaths caused by kidney stones and renal failure have been...
by Steven Perez | May 9, 2010 | Analytical Testing News & Updates | ADPEN Laboratories, Food Safety Links
ADPEN provides analysis results at a faster rate for Fluoroquinolones. Fluoroquinolones are a subgroup of the quinolone antibiotics that were discovered within the last decades. These are employed against almost all bacterial infections, particularly against urinary...
by Steven Perez | May 9, 2010 | Analytical Testing News & Updates | ADPEN Laboratories, Food Safety Links
ADPEN is currently utilizing the validated FDA LC/MS/MS methods which can detect down to 0.3 ppb for seafood and honey. ADPEN has also validated a modification of this method for use in milk by products and other matrices. ADPEN can help food companies implement...
