New pharmaceutical products require significant resources from concept to final market introduction. Every step along the way is paved with trials and tribulations. A successful new drug application requires a thorough nonclinical (also known as “preclinical”) toxicology safety package (e.g., adsorption, distribution, metabolism, and excretion (ADME), pharmacokinetic (PK) and toxicokinetic (TK)), a successful clinical program (Phases I, II, III and IV), and a comprehensive chemistry, manufacturing and controls (CMC) package. All toxicology safety packages are highly dependent upon accurate and precise analytical methods for quantifying the drug dosage formulations which are administered to the hosts. If the vehicle is free of interference, the dose formulations are carefully prepared according to the batch records, and the aliquots are stored appropriately, then the dose formulations should be at the correct concentrations when administered to the hosts. However, attention to detail alone is not enough to ensure a successful formulation or regulatory compliance.

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