Clinical evaluation, drugs roles

Medical/clinical reviewers, often called medical officers, are almost exclusively physicians. In rare instances, nonphysicians are used as medical officers to evaluate drug data. Medical reviewers are responsible for evaluating the clinical sections of submissions, such as the safety of the clinical protocols in an IND or the results of this testing as submitted in the NDA. Within most divisions, clinical reviewers take the lead role in the IND or NDA review and are responsible for synthesizing the results of the animal toxicology, human pharmacology, and clinical reviews to formulate the overall basis for a recommended agency action on the application. 

Study design plays a critical role in the clinical evaluation of drugs. A clinical study cannot be conducted without specifically outlined objectives and a definitive plan, which are vital components around which the study protocol is constructed. The use of placebo or active drug control groups in the study, and whether the design should be open, parallel, or crossover, must be determined. In most studies, patients are assigned to study groups randomly. 

One property of a crystalline compound is its ability to form polymorphs, that is, more than one crystal form for the same molecular entity. The phenomenon of polymorphism plays a critical role in the pharmaceutical industry because it affects every phase of drug development, from initial drug discovery to final clinical evaluation, including patent protection and competition in the market. A critical challenge is the early identification of possible polymorphs. Chapters 2 and 3 will address this key issue. 

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