Frontiers in Medicine | Regulatory Science

Original Research

Published on 12 Nov 2021

Process Evaluation of Internet-Based Cognitive Behavioral Therapy Intervention for Informal Caregivers

in Regulatory Science

Ieva Biliunaite
Evaldas Kazlauskas
Robbert Sanderman
Gerhard Andersson

Frontiers in Medicine

doi 10.3389/fmed.2021.725510

4,898 views
7 citations

Review

Published on 02 Nov 2021

Challenges During Review of COVID-19 Research Proposals: Experience of Faculty of Medicine, Ain Shams University Research Ethics Committee, Egypt

in Regulatory Science

Diaa Marzouk
Iman Sharawy
Isabelle Nakhla
Mostafa El Hodhod
Hoda Gadallah
Amr El-Shalakany
Reda Elwakil
Mohammed M. Moussa
Alaa Ismail
Fathy M. Tash

Frontiers in Medicine

doi 10.3389/fmed.2021.715796

3,954 views
7 citations

Original Research

Published on 01 Nov 2021

Biomarker and Companion Diagnostics—A Review of Medicinal Products Approved by the European Medicines Agency

in Regulatory Science

Laura Patricia Orellana García
Falk Ehmann
Philip A. Hines
Armin Ritzhaupt
Angela Brand

Frontiers in Medicine

doi 10.3389/fmed.2021.753187

15,341 views
23 citations

Perspective

Published on 27 Oct 2021

A Learning Health System Framework to Operationalize Health Data to Improve Quality Care: An Australian Perspective

in Regulatory Science

Joanne C. Enticott
Angela Melder
Alison Johnson
Angela Jones
Tim Shaw
Wendy Keech
Jim Buttery
Helena Teede

Frontiers in Medicine

doi 10.3389/fmed.2021.730021

10,708 views
26 citations

Review

Published on 26 Oct 2021

R&D Costs of New Medicines: A Landscape Analysis

in Regulatory Science

Steven Simoens
Isabelle Huys

Frontiers in Medicine

doi 10.3389/fmed.2021.760762

30,856 views
65 citations

Original Research

Published on 22 Oct 2021

Process Evaluation of an Online SUpport PRogram for Older Hearing Aid Users Delivered in a Cluster Randomized Controlled Trial

in Regulatory Science

Janine F. J. Meijerink
Marieke Pronk
Birgit I. Lissenberg-Witte
Vera Jansen
Sophia E. Kramer

Frontiers in Medicine

doi 10.3389/fmed.2021.725388

2,733 views

Brief Research Report

Published on 11 Oct 2021

Identification of Novel Modalities Through Bibliometric Analysis for Timely Development of Regulatory Guidance: A Case Study of T Cell Immunity

in Regulatory Science

Ai Fukaya-Shiba
Kouhei Otsuka
Hajime Sasaki
Mayumi Shikano
Rika Wakao

Frontiers in Medicine

doi 10.3389/fmed.2021.756870

5,217 views
3 citations

Review

Published on 11 Oct 2021

Network Meta-Analysis of 10 Storage Mediums for Preserving Avulsed Teeth

in Regulatory Science

Na Zhang
Yuzhao Cheng
Fenglan Li
Qian Kang

Frontiers in Medicine

doi 10.3389/fmed.2021.749278

7,731 views
7 citations

Systematic Review

Published on 04 Oct 2021

Pediatric Clinical Trials in Mainland China Over the Past Decade (From 2009 to 2020)

in Regulatory Science

Wen-Wen Wu
Xing Ji
Hao Wang
Feng Chen
Qian Ding
Guan-dong Zhang
Man Li
Shan-shan Wang
Ming-ming Ni
Qing-qing Liu

Frontiers in Medicine

doi 10.3389/fmed.2021.745676

4,417 views
5 citations

Original Research

Published on 09 Sep 2021

Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities

in Regulatory Science

Hasumati Rahalkar
Alan Sheppard
Gustavo Mendes Lima Santos
Chitralekha Dasgupta
Sonia Mayra Perez-Tapia
Carlos A. Lopez-Morales
Sam Salek

Frontiers in Medicine

doi 10.3389/fmed.2021.726660

27,525 views
12 citations

Study Protocol

Published on 06 Sep 2021

A Protocol for the Use of Case Reports/Studies and Case Series in Systematic Reviews for Clinical Toxicology

in Regulatory Science

Aboubakari Nambiema
Grace Sembajwe
Juleen Lam
Tracey Woodruff
Daniele Mandrioli
Nicholas Chartres
Marc Fadel
Adrien Le Guillou
Remi Valter
Marie Deguigne

Frontiers in Medicine

doi 10.3389/fmed.2021.708380

40,646 views
46 citations

Original Research

Published on 27 Aug 2021

Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward

in Regulatory Science

Tariro Sithole
Gugu Mahlangu
Velma Capote
Tania Sitoie
Saren Shifotoka
Johannes Gaeseb
Silverani Padayachee
Tohlang Sehloho
Akida Khea
Adam Fimbo

Frontiers in Medicine

doi 10.3389/fmed.2021.742181

3,551 views
13 citations

Original Research

Published on 27 Aug 2021

Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward

in Regulatory Science

Tariro Sithole
Gugu Mahlangu
Velma Capote
Tania Sitoie
Saren Shifotoka
Johannes Gaeseb
Lorraine Danks
Portia Nkambule
Alex Juma
Adam Fimbo

Frontiers in Medicine

doi 10.3389/fmed.2021.742200

5,987 views
8 citations

Policy and Practice Reviews

Published on 27 Aug 2021

Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit–The EU Regulator's Perspective

in Regulatory Science

Maria E. Sheean
Frauke Naumann-Winter
Giuseppe Capovilla
Maria Elisabeth Kalland
Eva Malikova
Segundo Mariz
Darius Matusevicius
Robert Nistico
Brigitte Schwarzer-Daum
Stelios Tsigkos

Frontiers in Medicine

doi 10.3389/fmed.2021.744625

5,973 views
6 citations

Original Research

Published on 27 Aug 2021

PRAgmatic Clinical Trial Design of Integrative MediCinE (PRACTICE): A Focus Group Series and Systematic Review on Trials of Diabetes and Kidney Disease

in Regulatory Science

Kam Wa Chan
Pak Wing Lee
Crystal Pui-sha Leung
Yee Kwan Law
Lucy Gao
Gary Chi-wang Chan
Wai Han Yiu
Tai Pong Lam
Sydney Chi-wai Tang

Frontiers in Medicine

doi 10.3389/fmed.2021.668913

5,065 views
12 citations

Review

Published on 25 Aug 2021

Implementation and Access to Pre-exposure Prophylaxis for Human Immunodeficiency Virus by Men Who Have Sex With Men in Europe

in Regulatory Science

Bruno Sepodes
João Rocha
Jorge Batista
Maria-Eduardo Figueira
František Dráfi
Carla Torre

Frontiers in Medicine

doi 10.3389/fmed.2021.722247

47,162 views
7 citations