Ateneo - UPO

The module explores the role of pharmaceutical development within the Drug Discovery and Development process, with particular emphasis on the scientific decisions that guide the transformation of a drug candidate into a developable and manufacturable drug product.
Through the discussion of real-world case studies, students will integrate the knowledge acquired in previous courses in Medicinal Chemistry, Pharmaceutical Technology and Pharmacology to critically assess the developability of drug candidates, identify the major development challenges and compare alternative formulation strategies.
The principles of Quality by Design (QbD) will be applied as practical tools to support scientific decision-making throughout pharmaceutical development and the rational design of drug products. The course will also present examples of the use of Generative Artificial Intelligence as a support tool for literature searching, organization of scientific information and generation of development hypotheses, promoting its critical, transparent and responsible use, always complemented by the verification of information through reliable scientific sources.
Teaching activities will be primarily based on the discussion of case studies and the guided design of pharmaceutical development strategies.

Caliceti P., Tecnologia Farmaceutica, CEA – Casa Editrice Ambrosiana, ultima edizione; Aulton M.E., Taylor K.M.G., Aulton's Pharmaceutics. The Design and Manufacture of Medicines, Elsevier, ultima edizione.

Upon completion of the module, students will have acquired the ability to understand and critically analyse the role of pharmaceutical development within the Drug Discovery and Development process, assessing the developability of drug candidates and comparing alternative formulation strategies. They will be able to apply Quality by Design (QbD) principles to support scientifically sound development decisions, integrating knowledge from different disciplines and critically using scientific literature and digital tools. Students will also be able to communicate their decisions clearly and rigorously and to address realistic pharmaceutical development challenges with independent judgement, a multidisciplinary perspective, and a problem-solving approach.

Students are expected to have a basic knowledge of Medicinal Chemistry, Pharmaceutical Technology and Pharmacology, particularly with regard to drug properties, drug delivery systems and the fundamental principles of formulation development. Access to the final assessment is subject to the prerequisites established by the Degree Programme regulations.

Teaching activities will combine lectures with case studies and practical exercises focused on the analysis of realistic pharmaceutical development challenges. Students will be actively engaged in the critical evaluation of alternative formulation strategies and in the application of Quality by Design (QbD) principles to support scientific decision-making. The course will also include the analysis of scientific literature and the guided use of digital tools and generative Artificial Intelligence to support literature searches, information management, and development planning, promoting their critical and responsible use.

Students with physical disabilities, Learning Disabilities or Special Education Needs can request specific services and tools via the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti, consulting the University webpage: https://www.uniupo.it/en/services/services-students-physical-or-learning-disabilities Students with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects.

Assessment will be carried out as part of the integrated final examination for the course Drug Discovery and Development. The examination consists of a written test common to all course modules, accounting for 60% of the final grade, with the score calculated as the weighted average of the marks obtained in the individual modules, and an oral presentation of a multidisciplinary case study developed during the course, accounting for the remaining 40% of the final grade.

The module introduces the role of pharmaceutical development within the Drug Discovery and Development process, examining how a drug candidate is transformed into a developable, manufacturable, and clinically suitable pharmaceutical product. The main factors influencing the developability of a drug candidate will be discussed, with particular emphasis on its physicochemical and biopharmaceutical properties and their impact on formulation development strategies.
The course will examine the criteria guiding the selection of dosage forms and formulation strategies according to the characteristics of the active pharmaceutical ingredient (API), the route of administration, therapeutic objectives, and product quality requirements. Through case studies, alternative development strategies will be compared, highlighting the major trade-offs between efficacy, stability, bioavailability, quality, and manufacturability.
The module will introduce the principles of Quality by Design (QbD) as a systematic approach to pharmaceutical development, illustrating how they can be applied to define development objectives, identify Critical Quality Attributes (CQAs), assess development risks, and support evidence-based decision-making throughout the development process.
Particular emphasis will be placed on the critical analysis of case studies involving the development of innovative medicines, with the aim of integrating knowledge from medicinal chemistry, pharmacology, and pharmaceutical technology into a unified pharmaceutical development strategy. The course will also present examples of the use of scientific literature, digital tools, and generative Artificial Intelligence to support literature retrieval, information management, and development planning, while promoting their critical, transparent, and responsible use.

Upon successful completion of the module, students will be able to understand the role of pharmaceutical development within the Drug Discovery and Development process and critically evaluate its main challenges. They will be able to assess the developability of drug candidates, compare alternative formulation strategies, and apply Quality by Design (QbD) principles to support evidence-based development decisions. Students will also be able to integrate knowledge from different disciplines, critically use scientific literature and digital tools, and communicate pharmaceutical development strategies in a clear and scientifically rigorous manner.