78 articles

Putting external validation performance of major bleeding risk models into context

in Cardiovascular Drug Safety

• Clair Blacketer
• Jenna M. Reps
• Lu Wang
• Patrick B. Ryan
• Zhong Yuan

Effectiveness and tolerability of Poliprotect, a natural mucosal protective agent for gastroesophageal reflux disease and dyspepsia: Surveys from patients, physicians, and pharmacists

in Substance-Based Medical Devices

• Roberto Cioeta
• Paola Muti
• Marta Rigoni
• Luigi Morlando
• Filippo Siragusa
• Andrea Cossu
• Emiliano Giovagnoni

New regulation on medical devices made of substances: Opportunities and challenges for pharmacological and toxicological research

in Substance-Based Medical Devices

• Carmela Fimognari
• Enrique Barrajón-Catalán
• Cristina Luceri
• Eleonora Turrini
• Emanuel Raschi
• Elisabetta Bigagli

Substance-based medical devices made of natural substances: An opportunity for therapeutic innovation

in Substance-Based Medical Devices

• Emiliano Giovagnoni

Towards a European harmonization of health technology assessment recommendations executive paper of European regulatory conference focused on the EU commission proposal to harmonize HTA

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

• Lucia Gozzo
• Kenneth Paterson
• Olivier Wong
• Francis Megerlin
• Jan Geldmacher
• Patrizia Popoli
• Claudio Jommi
• Frank-Ulrich Fricke
• Oriol De Solà-Morales
• Isao Kamae

Medical Devices Made of Substances: A New Challenge

in Substance-Based Medical Devices

• Maria Grazia Leone

Medical Devices Made of Substances: The Need for a Change in Approach in Paediatrics

in Substance-Based Medical Devices

• Stefano Stagi

Pharmacological Versus Non-Pharmacological and Ancillary Mechanisms in Eye Drops Used in the Treatment of Glaucoma

in Substance-Based Medical Devices

• Nicoletta Marchesi
• Foroogh Fahmideh
• Annalisa Barbieri
• Marco Racchi
• Alessia Pascale
• Stefano Govoni

Increased Confidence in Deduplication of Drug Safety Reports with Natural Language Processing of Narratives at the US Food and Drug Administration

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

• Kory Kreimeyer
• Oanh Dang
• Jonathan Spiker
• Paula Gish
• Jessica Weintraub
• Eileen Wu
• Robert Ball
• Taxiarchis Botsis

Digital Therapeutics in Perspective: From Regulatory Challenges to Post-Marketing Surveillance

in Substance-Based Medical Devices

• Salvatore Crisafulli
• Eugenio Santoro
• Giuseppe Recchia
• Gianluca Trifirò

Efficacy and Safety of a Polysaccharide-Based Natural Substance Complex in the Treatment of Obesity and Other Metabolic Syndrome Components: A Systematic Review

in Substance-Based Medical Devices

• Giuseppina Guarino
• Felice Strollo
• Peter Malfertheiner
• Teresa Della Corte
• Stefano Stagi
• Mario Masarone
• Sandro Gentile

Current Status and Future Challenges in the Treatment of Rheumatic Diseases

in Rheumatic Drug Safety

• Enrique R. Soriano

A New Era of Pharmacovigilance: Future Challenges and Opportunities

• Gianluca Trifirò
• Salvatore Crisafulli

Moving to a Personalized Approach in Respiratory Medicine. From Academic Research to Regulatory Intervention

in Respiratory Drug Safety

• Mario Cazzola