Digital health and Artificial Intelligence (AI) have begun to change the face of the global healthcare markets in recent years. Many different stakeholders are engaged in all aspects of the digital transformation of health and care, leading to a continuous transition from traditional processes and services to more advanced, technology-driven solutions. A wide range of emerging digital health technologies are available, opening up many opportunities not only for patients but for all involved players in the industry. Although being part of a traditionally very conservative industry and despite having initiated this transformation substantially after digitally mature industries such as financial services and telecommunications, pharmaceutical and life science companies have closed the gap and proven digital affinity via innovative product launches in mobile and telehealth as well as AI-supported process optimizations. Building upon a previous publication on "mHealth" [1], the authors evaluate in a set of 2 consecutive articles the current landscape of AI and digitalization offers, their explicit benefits for various stakeholders as well as the challenges to be faced during development and marketing.
Almost all countries in the world follow the harmonized GxP standards of the World Health Organization (WHO) and have implemented respective rules in their guidelines. Nevertheless, there are some slight differences from country to country mainly influenced by the respective cultures in these countries. Religion, political systems, and history have noteworthy influence on that. Japan is known for high quality with the target of zero defect which makes it difficult for foreign suppliers to achieve these requirements. China is hesitating to import materials from abroad and the import license registration of a new material can take several years. On the other side, China is improving the quality and compliance of their manufacturers. Now the government even allows manufacturers to export drug products to other countries as contract manufacturers. For a global player, the manufacturing strategy is complex to follow all these rules. Best is to perform key manufacturing processes with specific requirements in these countries. To supply from a global site this may require large resources and a business case should be elaborated to compare extra costs with extra benefits.
Multiparticulates such as (micro)pellets and minitablets represent modern and innovative technology platforms, providing advantages when compared to monolithic oral dosage forms. Better compliance is achieved for children and the elderly. Individually tailored drug release profiles for any API and site-specific drug delivery allow for an optimized and safe therapeutic effect. Various drug products can be made from one multiparticulate form - capsules, oral liquids, sachets, stick packs, sipping straws, fixed-dose combinations, and multiple unit pellet system (MUPS) tablets - offering interesting perspectives for life cycle management. 3D printing of multiparticulate systems is a step into future technology. New concepts for patient-centric solutions are possible. Small particles are easily administered via nasal and gastrointestinal tubes. Moreover, the pellet concept facilitates the processing of highly potent compounds to an extraordinary degree.
Test procedures used in the GMP environment must be suitable for the intended application, i.e. H. be validated. This suitability must be proven before the first routine use, but must also be demonstrated for every application, i.e. H. throughout the entire analytical life cycle. The 7 elements of method validation were presented in issue 05/2022. In this article you will learn how to plan, carry out and evaluate the validation of the individual parameters.
In 2021, 2 draft guidelines about computerized systems and Digital Health Technology (DHT) in clinical investigation were published by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). The following article is a brief summary about the FDA DHT draft guidance with consideration of the EMA draft guideline.
