Nonclinical pharmacokinetic (PK) and toxicokinetic (TK) toxicology safety studies are performed using goodlaboratory practice (GLP) regulations to ensure the availability of safe medicines. International GLP regulationsuniformly require that dose concentration, homogeneity/uniformity and stability be known prior to administration.However, the United States Food and Drug Administration (US FDA) and the Organisation for Economic Co-operation and Development (OECD) both confirmed that GLPs do not apply to validation of analytical methodsused to determine the concentration of GLP test article in drug dosage forms. It is our assertion that the outcomeof nonclinical toxicology safety studies is inherently dependent upon accurate and precise dose formulations.In this paper, we attempt to provide supporting evidence as to why formulation method validation and sampleanalysis for supporting nonclinical toxicology studies should be consistently conducted under the framework ofGLP principles across the globe. GLP studies are planned, performed, monitored, recorded, reported and archivedaccording to a protocol, study plan or standard operating procedure (SOP) which is authorized prior to performingthe experiments. All applicable experimental parameters and associated acceptance criteria are pre-defined. TheFDA asked for responses to the Advance Notice of Proposed Rulemaking for 21 CFR Part 58 GLPs for NonclinicalLaboratory Studies [Docket No. FDAââ?¬â??2010ââ?¬â??Nââ?¬â??0548] on December 21, 2010. Several comments were receivedstating that guidance regarding the validation of formulation analysis methods and subsequent use for supportingGLP toxicology study sample analysis is warranted at this time and should be conducted consistently. Adherence toGLP principles for method validation and sample analysis would inherently improve the quality of nonclinical safetystudies. Furthermore, the recently published White Paper titled, ââ?¬Å?Nonclinical dose formulation analysis methodvalidation and sample analysisââ?¬Â should be the keystone of this effort.
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