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API/FDF Analytical Testing Site

Known as: API/FDF Analytical Testing, Active Pharmaceutical Ingredient / Finished Dosage Form Analytical Testing Site, Analytical Testing 
Sites that perform testing of the characteristics and attributes of active pharmaceutical ingredients or finished dosage forms.
National Institutes of Health

Related topics

Related topics

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Structured Product Labeling Business Operation Terminology

Papers overview

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Review
2012
Review
2012
Recent Trends in the Development of Oral dissolving Film
Oral dissolving films are formulated by incorporating the drug with selected oral cavity absorption enhancers in a specially… 
Review
2010
Review
2010
Immunogenicity of therapeutics: a matter of efficacy and safety
Importance of the field: The unwanted immunogenicity of therapeutic proteins is a major concern regarding patient safety… 
2009
2009
Analytical control of genotoxic impurities in the pazopanib hydrochloride manufacturing process.
Review
2008
Review
2008
The clinical need for high-sensitivity cardiac troponin assays for acute coronary syndromes and the role for serial testing.
Highly Cited
2008
Highly Cited
2008
Demonstration of Robust Host Cell Protein Clearance in Biopharmaceutical Downstream Processes
Residual host cell protein impurities (HCPs) are a key component of biopharmaceutical process related impurities. These… 
2007
2007
Application of chromatographic theory for process characterization towards validation of an ion‐exchange operation
The behavior of ion‐exchange chromatography is well understood with respect to changes in ionic strength, pH, resin ligand… 
Highly Cited
2003
Highly Cited
2003
Forensic applications of chemical imaging: latent fingerprint detection using visible absorption and luminescence.
Chemical imaging technology is a rapid examination technique that combines molecular spectroscopy and digital imaging, providing… 
Review
2000
Review
2000
Techniques for analytical testing of unconventional samples.
Forensic scientists have long detected the presence of drugs and their metabolites in biological materials using body fluids such… 
1998
1998
System for dynamic measurements of membrane capacitance in intact epithelial monolayers.
Review
1960
Review
1960
Removal of Heavy Metal and Halide Contamination from Macronutrient Salts.
In micronutrient deficiency experiments with plants the salts used to supply macronutrients must obviously be free of significant… 
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