A pharmaceutical form or substance being tested for potential therapeutic use, but which has not yet received full regulatory approval for widespread marketing, falls under a specific classification. This encompasses products undergoing clinical trials to assess safety and efficacy. Such a product may be a new chemical entity, a reformulation of an existing medicine, or a medicine being investigated for a new indication.
The development and assessment of these products are crucial for advancing medical knowledge and providing patients with innovative treatment options. Rigorous testing protocols are implemented to minimize risks and ensure that any potential benefits outweigh possible harms. This process often involves multiple phases, each designed to evaluate different aspects of the product’s behavior and effectiveness within the human body. Historically, the systematic evaluation of these compounds has led to significant improvements in patient outcomes and the management of various diseases.