Clinical studies human drug products

To determine whether human testing for a new drug or new drug product is reasonable, it is first necessary to conduct preclinical studies and to submit the IND. The necessary information needed to prepare the IND is outlined in Table 1. The IND is to contain information on appropriate prior animal studies for safety evaluation, any available clinical data, adequate drug identification and manufacturing instructions, and a detailed outline of the proposed clinical study, routs of administration, approximate number of patients to be used, and an estimate of the length of treatment and an environmental impact statement. 

Of ultimate importance are the full reports of the clinical studies in humans and their results. These data will be treated statistically for their validity. The number of studies for a specific compound or combination of compounds will vary with the type of drug being tested, as will the number of tests needed to appraise relative or absolute safety and to clearly demonstrate efficacy. The basic requirement is the proof of safety and efficacy of the product being submitted under the NDA system. A drug that does not contribute to therapy, such as a new antihistamine that does not demonstrate greater safety or efficacy, or both, compared with drugs already on the market, will have a difficult or impossible time achieving approval. 

CSline. CSline [84] provides information on well-designed and well-executed clinical trials of drugs currently under study or in use in humans. This information includes study objectives, design, population, intervention groups, withdrawals, adverse reactions, endpoints and results, conclusions, and references. The CSline database covers more than 500 drugs currently on the market or in development. Pharmacological data from more than 2000 journal articles, congresses, and books are added each year. The product is commercially available on CD-ROM from Prous Science and is updated every 2 months. 

Guidance for Industry For the Evaluation of Combination Vaccines for Preventable Diseases Production, Testing and Clinical Studies. U.S. Department of Health and Human Services, Food and Drug Administration Center for Biologies Evaluation and Research. April 1997. 

Animal data serve as the springboard to estimating a safe and effective range of doses for human therapeutic purposes. Initial doses in phase 1 studies are based on preclinical pharmacokinetic and safety data. First estimates of safe and effective drug concentrations in plasma in human studies are also based on animal data. The Clinical Studies section in the product label includes information derived from tolerance studies of the drug (phase I), pivotal human data demonstrating efficacy at a defined dose or dose range, and a description of untoward effects observed in... 

Clinical trials, also known as clinical studies, test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. Potential treatments, however, must be studied in laboratory animals first to determine potential toxicity before they can be tried in people. Treatments having acceptable safety profiles and showing the most promise are then moved into clinical trials. 

During the early preclinical development of a new drug, the sponsor s primary goal is to determine if the product is reasonably safe for initial use in humans and if the compound exhibits pharmacological activity that justifies commercial development. When a product has been identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies. 

Comparative Clinical Studies. Where there are no other means, well-controlled clinical trials in humans may be useful to provide supportive evidence of BA or BE. However, the use of comparative clinical trials as an approach to demonstrate BE is generally considered insensitive and should be avoided where possible (21 CFR 320.24). The use of BE studies with clinical trial end points may be appropriate to demonstrate BE for orally administered drug products when measurement of the active ingredients or active moieties in an accessible biological fluid (pharmacokinetic approach) or pharmacodynamic approach is infeasible. 

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