Guideline, FDA

The concern by consumers about cholesterol has stimulated the development of methods for its removal. Three principal approaches are in the pilot-plant stages use of enzymes, supercritical fluid extraction, and steam distillation. Using known techniques, it is not possible to remove all cholesterol from milk. Therefore, FDA guidelines identify cholesterol-free foods as containing less than 2 mg cholesterol per serving, and low cholesterol foods as containing from 2 to 20 mg (37). 

FDA Guideline for Submitting Documentation for the Stability of Fluman Drugs and Biologies, Center for Drugs and Biologies, February 1987... 

FDA Guideline to Inspection of Validation of Cleaning Processes, Office of Regulatory Affairs, July 1993... 

Linearity verifies that sample solutions are in a concentration range in which the detector response is linearly proportional to analyte concentration. Current FDA guidelines call for establishing linearity. For regulatory methods, this is generally performed by preparing standard solutions at four or five concentrations, from 30 to 200% of the tolerance. 

FDA guidelines for concentrations in foods Experimental Results in Use factors for consumption of particular foods Laboratory Animal Studies FDA... 

Where Cf FDA guideline for PBB concentration In fat (26), the SPPPLV for the soil ingestion pathway is then... 

Although the power of research MRI/MRS machines for human use can be as high as 9.4 T, the FDA has imposed a limit of 3 T for routine clinical human use. Industrial manufacturers of MRI equipment are very careful to conform to all the FDA guidelines regarding magnetic field strength, gradient speed and RF power (see Appendix Basic principles of MRI). 

ICH Stage FDA Guidelines Great Britain and EEC Guidelines Japanese Guidelines EPA OPPTS, OECD and FDA Redbook Guidelines... 

The IV-IVC is generally established by comparing in vitro dissolution of drug with certain in vivo PK parameters. There are certain FDA guidelines for this purpose, where the correlations are categorized as Level A, Level B, Level C, and multiple Level C correlations.84... 

The publication of the U.S. FDA Guidelines allowing the waiver of bioequivalence study for compounds classified as Class I based on the Biopharmaceutics Classification System... 

The FDA Guideline for Drug Master Files (21 CFR Part 314.420) consists of the following sections ... 

The following is the FDA definition for Process Validation (FDA Guidelines on General Principles of Process Validation, May 1987) ... 

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