Recent Advances in Regulatory Science for Pharmaceutical Development and Approval DOI Open Access
Ali Rahmani,

Ali Rahmani,

Maedeh Dahaghin

и другие.

Journal of Pharmaceutical Research, Год журнала: 2023, Номер 8(2)

Опубликована: Июль 18, 2023

Regulatory science is a vital component of pharmaceutical development and approval processes, ensuring the safety, efficacy, quality drugs. This article provides an overview background importance regulatory in industry. It highlights critical role plays supporting innovation creating predictable transparent environment. Recent advances are discussed, including use real-world evidence, innovative trial designs, advancements gene cell therapies. These developments have potential to revolutionize drug approval, offering new treatment options improving patient outcomes. However, they also introduce challenges that need be addressed, such as reliability evidence adapting complex landscape Understanding evolving field crucial for professionals navigate bring safe effective therapies patients.

Язык: Английский

PROTACs: Emerging Targeted Protein Degradation Approaches for Advanced Druggable Strategies DOI Creative Commons

Nuwayo Ishimwe Sincere,

Krishnan Anand, Sumel Ashique

и другие.

Molecules, Год журнала: 2023, Номер 28(10), С. 4014 - 4014

Опубликована: Май 10, 2023

A potential therapeutic strategy to treat conditions brought on by the aberrant production of a disease-causing protein is emerging for targeted breakdown using PROTACs technology. Few medications now in use are tiny, component-based and utilize occupancy-driven pharmacology (MOA), which inhibits function short period time temporarily alter it. By utilizing an event-driven MOA, proteolysis-targeting chimeras (PROTACs) technology introduces revolutionary tactic. Small-molecule-based heterobifunctional hijack ubiquitin–proteasome system trigger degradation target protein. The main challenge PROTAC’s development facing find potent, tissue- cell-specific PROTAC compounds with favorable drug-likeness standard safety measures. ways increase efficacy selectivity focus this review. In review, we have highlighted most important discoveries related proteins PROTACs, new approaches boost proteolysis’ effectiveness development, promising future directions medicine.

Язык: Английский

Процитировано

37

Towards a New Paradigm for Digital Health Training and Education in Australia: Exploring the Implication of the Fifth Industrial Revolution DOI Creative Commons
Toh Yen Pang, Tsz-Kwan Lee, Manzur Murshed

и другие.

Applied Sciences, Год журнала: 2023, Номер 13(11), С. 6854 - 6854

Опубликована: Июнь 5, 2023

Digital transformation, characterised by advanced digitalisation, blockchain, the Internet of Things, artificial intelligence, machine learning technologies, and robotics, has played a key role in revolutionising various industries, especially healthcare sector. The adoption transition (from traditional) to new technology will bring challenges, opportunities, disruptions existing systems. According European Union, we must pursue both digital green transitions achieve sustainable, human-centric, resilient industries world prosperity for all. study aims present novel approach education training health field that is inspired fifth industrial revolution paradigm. paper highlights interventions are required support future so students can develop capacity recognise exploit potential technologies. This article briefly discuss challenges opportunities related systems era transformation beyond. Then, look at enabling technologies from an Industry 5.0 perspective supports health. Finally, teaching paradigm strategies embed academic curricula their capacities embrace minimise disruption inevitably accompany it. By incorporating principles into education, believe gain deeper understanding industry skills enable them deliver more efficient, effective, sustainable system.

Язык: Английский

Процитировано

23

CRISPR-Based Therapies: Revolutionizing Drug Development and Precision Medicine DOI
Dilip Kumar Chanchal, Jitendra Singh Chaudhary, Pushpendra Kumar

и другие.

Current Gene Therapy, Год журнала: 2024, Номер 24(3), С. 193 - 207

Опубликована: Фев. 4, 2024

With the discovery of CRISPR-Cas9, drug development and precision medicine have undergone a major change. This review article looks at new ways that CRISPR-based therapies are being used how they changing way is done. CRISPR technology's ability to precisely flexibly edit genes has opened up find, validate, develop targets. Also, it made for personalized gene therapies, precise editing, advanced screening techniques, all which hold great promise treating wide range diseases. In this article, we look latest research clinical trials show could be treat genetic diseases, cancer, infectious other hard-to-treat conditions. However, ethical issues problems with regulations also discussed in relation shows important use them safely responsibly. As continues change drugs used, shines light on amazing things been done what future might rapidly field.

Язык: Английский

Процитировано

10

Digital Frontiers in Healthcare: Integrating mHealth, AI, and Radiology for Future Medical Diagnostics DOI Creative Commons
Reabal Najjar

Biomedical engineering, Год журнала: 2024, Номер unknown

Опубликована: Янв. 23, 2024

In an era where technology and healthcare increasingly intertwine, we stand on the precipice of a seismic shift in future medicine. This chapter unravels confluence mHealth, artificial intelligence (AI), radiology as it navigates labyrinth these advancements, dissecting their unique qualities, historical evolution, projected trajectories. From democratising potential mHealth to AI’s analytical might, transformative journey medical imaging from film digital—the offers deep dive into current realities horizons. Further, intersection domains is explored, illuminating revolutionary role enhancing capabilities through advances imaging. An exhaustive review cutting-edge applications ethico-regulatory conundrums they pose, forms substantial part discourse, followed by foresight anticipated technological breakthroughs, impacts, critical policymakers health leaders this odyssey. The culminates holistic synthesis, tying together strands preceding sections underscore triumvirate. text designed captivating exploration, reflective critique, roadmap for collectively navigate towards technologically empowered era.

Язык: Английский

Процитировано

8

Navigating the technological landscape in hospitals: A taxonomy of scanning and assessment integration types anchored in innovation orientation and specialization of care DOI Creative Commons
Maria Pinelli, Emanuele Lettieri, Fabian Bernhard

и другие.

Technological Forecasting and Social Change, Год журнала: 2025, Номер 212, С. 123986 - 123986

Опубликована: Янв. 23, 2025

Язык: Английский

Процитировано

0

Challenges in Sustainable Pharmaceutical Development DOI
Thuy Trang Nguyen, Nguyen Thi Trang

Опубликована: Янв. 1, 2025

Язык: Английский

Процитировано

0

Artificial Intelligence and Internet of Things Integration in Pharmaceutical Manufacturing: A Smart Synergy DOI Creative Commons

Reshma Kodumuru,

S. Sarkar,

Varun Parepally

и другие.

Pharmaceutics, Год журнала: 2025, Номер 17(3), С. 290 - 290

Опубликована: Фев. 22, 2025

Background: The integration of artificial intelligence (AI) with the internet things (IoTs) represents a significant advancement in pharmaceutical manufacturing and effectively bridges gap between digital physical worlds. With AI algorithms integrated into IoTs sensors, there is an improvement production process quality control for better overall efficiency. This facilitates enabling machine learning deep real-time analysis, predictive maintenance, automation—continuously monitoring key parameters. Objective: paper reviews current applications potential impacts integrating concert technologies like cloud computing data analytics, within sector. Results: Applications discussed herein focus on industrial analytics quality, underpinned by case studies showing improvements product reductions downtime. Yet, many challenges remain, including ethical implications AI-driven decisions, most all, regulatory compliance. review also discusses recent trends, such as drug discovery blockchain traceability, intent to outline future autonomous manufacturing. Conclusions: In end, this points basic frameworks that illustrate ways overcome existing barriers increased efficiency, personalization, sustainability.

Язык: Английский

Процитировано

0

In vivo CAR T cells and targeted gene delivery: A theme for the Pharmaceuticals and Medical Devices Agency Science Board to address DOI Creative Commons
Rika Wakao,

Ai Fukaya‐Shiba

Frontiers in Medicine, Год журнала: 2023, Номер 10

Опубликована: Апрель 17, 2023

OPINION article Front. Med., 17 April 2023Sec. Regulatory Science Volume 10 - 2023 | https://doi.org/10.3389/fmed.2023.1141880

Язык: Английский

Процитировано

8

Global Pipeline of Innovative Medicinal Products: A Narrative Review DOI Creative Commons
В. А. Меркулов, R.I. Yagudinа, V.G. Serpik

и другие.

The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products Regulatory Research and Medicine Evaluation, Год журнала: 2024, Номер 14(1), С. 14 - 28

Опубликована: Фев. 27, 2024

SCIENTIFIC RELEVANCE . The rapid expansion of the range medicines in global pharmaceutical market determines importance periodically reviewing innovative and products at various stages development. AIM. This study aimed to determine main trends development medicines. DISCUSSION review presents information on therapeutic effects value medicinal products, outlines current approaches their authorisation, addresses increase costs. authors used search, content analysis, horizon scanning methods prepare this narrative review. describes pipeline for second half 2023, both generally by specific aspects. determined that over 21,000 were time, with approximately 23% those later (from phase III clinical trials registration stage). predominant indications use cancers. separately reviewed innovations treatment Alzheimer’s disease, as well gene, cell, RNA therapies. CONCLUSIONS. A significant number have a high likelihood changing landscape disease treatment, prevention, diagnosis. With rising costs potential change underscores introducing predictive tools, such scanning, into national healthcare system.

Язык: Английский

Процитировано

2

Implementing Horizon Scanning as a tool for the strategic development of regulatory guidelines for nanotechnology-enabled health products DOI Creative Commons

Francisco D. Rodríguez-Gómez,

Dominique Monferrer,

Oriol Penon

и другие.

Frontiers in Medicine, Год журнала: 2024, Номер 10

Опубликована: Янв. 11, 2024

Strategic regulatory development is essential to ensure that new innovations in nanotechnology-enabled health products (NHPs) successfully reach the market and benefit patients. Currently, lack of specific guidelines for NHPs considered one primary causes so-called "valley death" these products, impacting both current future advancements. In this study, we have implemented a methodology anticipate key trends NHP compare them with landscape applicable NHPs. This relies on Horizon Scanning, tool commonly used by policymakers foresee needs proactively shape framework tailored those needs. Through application methodology, different been identified, notably drug delivery dental applications. Furthermore, most disruptive elements involve are multicomposite multifunctional, harnessing nano-scale properties combine therapeutic diagnostic purposes within single product. When compared landscape, regulations gradually adapting accommodate emerging trends, being developed. However, elements, multifunctional NHPs, their novelty still poses significant challenges, requiring strategic agencies safe effective integration into healthcare practices. study underscores importance proactive planning bridge gap between innovation implementation.

Язык: Английский

Процитировано

2