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NuAire | Pharmacy Compounding Aseptic Isolator [CAI] NU-PR797 Performance Evaluation
NuAire Inc.
The United States Pharmacopeia (USP) published USP Chapter 797, Pharmaceutical Compounding - Sterile Preparations. The chapter details the requirements of most every aspect of Compounded Sterile Preparations (CSP’s) from definitions of quality assurance programs practices and procedures necessary to provide the highest quality CSP’s to patients. Each state board of Pharmacy will determine to ...
 
Commercially Successful Cell Therapies eBook
Fisher BioServices
If you have a cell-based therapy in development, then you need to consider such variables as packaging, storage, in- ventory management, monitoring systems, distribution, and even clinical site capabilities well before you begin to pre- pare the Investigational New Drug (IND) submission to the Food and Drug Administration (FDA). By sidestepping these issues until clinical trials begin, you may ...
 
FDA Inspection – A Survival Guide
Tutela Monitoring Systems LLC
While the FDA are the regulatory body, there is actually no legal requirement to respond to a Form 483 inspection report. According to the FDA’s own website, a form 483 report records “inspectional observations, and do not represent a final agency determination regarding your compliance.” It all sounds quite benign, but the consequences and ramifications can be serious and a timely, proper, ...
 
Rat KidneyMAP
Myriad RBM, Inc.
A 12-Biomarker Multi-Analyte Profile (MAP) for Detecting Kidney Toxicity in Rat Preclinical Drug Studies. Sherry Sours-Brothers, Ph.D. and Dominic Eisinger, Ph.D. Introduction Rat KidneyMAP® and Biomarker Qualification by the Predictive Safety Testing Consortium Drug induced toxicity is responsible for killing 30% of promising compounds from early preclinical studies and can negatively impact ...
 
CASE STUDY-  Korott Labs – Nutricosmetics go Mainstream
Capsugel
 
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Jackson Laboratory's legacy of genetic discovery The Jackson Laboratory The Jackson Laboratory has been a significant force in genetic discovery for more than 80 years. We discover the genetic basis for preventing, treating ...
 
Tutela Wireless Temperature Monitoring Tutela Monitoring Systems LLC Tutela wireless temperature monitoring systems are fully FDA compliant, deliver unparalleled accuracy, and rock-solid audit trails for complete regulatory ...
 

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