Bioanalytical Method Validation: Metabolite Considerations Validated bioanalytical methods for the quantitation of drugs in biological matrix (e.g. blood, plasma, serum, or urine) are critical for the successful conduct of nonclinical- and clinical- bioequivalence and...
Bioanalytical Method Development: Therapeutic Peptides Therapeutic Peptides are short strings of amino acids, typically comprising 2–50 amino acids. The use of peptides as therapeutic (therapeutic peptides) agents started in 1922 with the first approval for the...
Bioanalysis Considerations for Endogenous Substance Drug Products Wait! We think you’ll find the following related article of similar interest. BIOANALYTICAL METHOD VALIDATION FOCUS ON SAMPLE STABILITY. To Read, Click Here. The term endogenous is the opposite of...
Bioanalytical Method Validation Focus on Sample Stability Bioanalytical method validation is performed to demonstrate that a given method is suitable for its intended use, i.e., in the quantitative analysis of drugs, metabolites and biomarkers in biological matrix...
Clinical Research Spotlight: Ketamine, Norketamine and Hydroxynorketamine Ketamine is a precipitation drug that was developed in the 1960s and approved as an anesthetic. Ketamine has been used on the battlefield to treat injured soldiers in the Vietnam War, in...
When is 505(b)(2) a Good Choice for Your New Drug Application? Taking a New Drug to Market When you want to market a new drug and there is enough evidence on the drug’s safety and efficacy, the 505(b)(2) is a desirable regulatory pathway for a New Drug Application...
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