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Regulatory evolution over the past 25 years has emphasized the development of age-appropriate formulations for pediatrics. Patient centricity in product development is essential for these formulations to succeed. This involves recognizing and addressing the physiological, psychological, and socioeconomic needs of both individual patients and larger pediatric populations within therapy design.
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Drug release profiles can be immediate, delayed immediate, sustained, or delayed sustained; dispersed formats exist that can achieve each profile. Specific release profiles are accomplished by applying purpose-built technologies and different combinations of materials in specific configurations; this can be done for dispersed dosage formats just as well as tablets.
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Early-stage development is an iterative process; as new data and insights are generated from preclinical studies, early clinical trials, and other research activities, adjustments and modifications to the product's formulation, dosage, delivery method, or target population may be necessary. This allows for product optimization and improvement based on emerging knowledge.
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Finding an outsourcing partner capable of giving your company proper attention and meeting project milestones on time is crucial to ensure patients in need receive treatment in a timely manner. Examine how a CDMO with the right expertise, preparation, and resources is instrumental in providing the supplies needed for successful clinical trials.
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Medication adherence is influenced by several factors, including the method of treatment, healthcare accessibility, a patient’s socioeconomic status, and the palatability and swallowability of a drug. For pediatric populations, adherence can be complicated by additional considerations. By partnering with an experienced CDMO, companies can increase acceptability of their drugs among pediatric patients.
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For orally delivered medicines, developers must carefully balance a drug’s “curb appeal” with its overall safety and efficacy. This includes optimizing its delivery mechanism to ensure proper absorption, designing a formulation with an acceptable taste to encourage adherence, and making administration as easy and convenient as possible, especially for pediatric or elderly patients.
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