Preclinical studies, drug guidelines

Presently there are no official, general guidelines for this kind of study available the different aspects are covered instead by dedicated guidelines, e.g. metabolism, related to drug interaction (US FDA 1999, US FDA 1997, EU CPMP 1997), or for the related preclinical studies (EU EUDRALEX 3BSlla 1994), or only in a high level form (EU EUDRALEX 3CC3a 1988). 

Guidelines for clinical trials have been established by the Food and Drug Administration (FDA) [6]. The classie model of clinical trial design takes pharmaceutical compounds that have shown some promise in preclinical experimentation through several levels of testing prior to implementation in clinical practice (Fig. 1). In general, preclinical studies in vitro and in animals... 

Table 3 indicates the preclinical safety studies for CAPTISOL (25) conducted as of 2005. The strategic safety plan for CAPTISOL was designed based on the guidelines discussed in the 1990s by the International Pharmaceutical Excipients Council which resulted in the May 2005 issuance of the FDA Guidance (26) Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients. These studies and others in the CAPTISOL Drug Master File have delineated the safety of CAPTISOL (SBE7-P-CD) for parenteral, ophthalmic, oral, nasal, and inhalation administration. 

If a compound is selected to enter preclinical development it is normally given significant resources and is expected to be around for an extended period of time. Now it is expected that the assay will be used more extensively to answer detailed questions about the drug with greater precision and confidence. The assay could be redeveloped and extensively characterized and tested so that it meets well-established guidelines for inter- and intraday precision and accuracy [54]. Other performance criteria, such as sample stability, are looked at as well. Sample preparation recovery could be denned in replicate. The assay is applied to large-scale, nonclinical studies in a variety of species. 

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