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3. Regulatory and Approval Fees Isoflurane is subject to strict regulatory requirements imposed by health authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The costs associated with obtaining and maintaining regulatory approvals, including clinical trials and post-market surveillance, are often reflected in the product’s price.
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The development process begins with drug discovery, focusing on identifying potential candidates that can effectively target specific biological pathways. During this phase, researchers explore various chemical entities to assess their activity against disease models. Once promising candidates emerge, they advance into preclinical studies, where APIs undergo rigorous testing for pharmacokinetics, pharmacodynamics, and toxicity. These studies ensure that selected APIs have the potential for success in clinical trials.
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Formulation refers to the process of combining APIs with other substances to develop a viable drug product. These additional substances, often referred to as excipients, can include fillers, binders, preservatives, and stabilizers. The formulation is crucial because it determines the drug's stability, absorption, distribution, metabolism, and excretion (ADME) properties.
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