The development of a new molecular entity (NME) into a drug can only be successful if the drug meets today's standards in terms of quality, efficacy, safety, and convenience. The better a new drug meets hitherto unmet therapeutic needs, the more successful it will be. Urgent needs for new drugs exist in the areas of chronic diseases. Safety requirements for drugs to be used chronically are paramount. Assessments of the therapeutic benefit as opposed to the risks of a new drug are important criteria for approval. As a consequence of these strict requirements which have precipitated in rules and regulations for biomedical testing and marketing approval in most countries of the world, the drug development process has expanded and in many instances leaves little of the effective patent life to recover the considerable investment needed for an innovation. The ethical and scientific principles of drug development and biomedical research are summarized in a highly condensed manner in the Declaration of Helsinki. Worldwide development and marketing approval is a necessary prerequisite for success. A scientific approach together with strategic goal setting, planning, and continuous monitoring can nonetheless increase the efficiency of the drug development process.
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