Therapeutic Innovation & Regulatory Science
Overview
Therapeutic Innovation & Regulatory Science is a peer-reviewed journal that focuses on the latest advancements in the field of drug development and regulatory affairs. It provides a platform for researchers, scientists, and regulatory professionals to share innovative approaches, methodologies, and insights to enhance the safety, efficacy, and accessibility of therapeutic products. The journal covers a wide range of topics, including clinical trials, pharmacovigilance, regulatory policies, and emerging technologies, making it an essential resource for those involved in the development and regu
Details
Details
Abbr.
Ther Innov Regul Sci
Start
2013
End
Continuing
Frequency
Bimonthly
p-ISSN
2168-4790
e-ISSN
2168-4804
Country
Switzerland
Language
English
Specialties
General Medicine
Pharmacology
Pharmacology
Metrics
Metrics
h-index / Ranks: 7207
51
SJR / Ranks: 7073
637
CiteScore / Ranks: 9425
2.60
JIF / Ranks: 6109
1.5
Recent Articles
1.
Williams D, Maidment J, Concepcion P, Zorenyi G
Ther Innov Regul Sci
. 2025 Mar;
PMID: 40080325
Lack of long-term safety data for the AYA population has been identified as a key area that reduces enrolment of AYA in adult oncology clinical trials. Here we describe a...
2.
Jones J, Califf R
Ther Innov Regul Sci
. 2025 Mar;
PMID: 40069512
Following the largest reorganization in its history, the U.S. Food and Drug Administration (FDA) is now working to modernize how it defines and engages in regulatory oversight of the quality...
3.
4.
Hatcher H, Stankeviciute S, Learn C, Qu A
Ther Innov Regul Sci
. 2025 Mar;
PMID: 40057669
Background: Biomarkers are an integral component in the drug development paradigm. According to the US Food and Drug Administration (FDA), a biomarker is "a defined characteristic that is measured as...
5.
Andersen L, Williams M, Pease S, Dhatt H, Delong P
Ther Innov Regul Sci
. 2025 Mar;
PMID: 40056370
Objectives: Patient-reported outcomes (PROs) are important measures of efficacy in the context of clinical trials but are sometimes identified as time and resource intensive to study participants and site personnel....
6.
Zhang Y, Zhang X, Wang P, Wu Y, Chow S
Ther Innov Regul Sci
. 2025 Mar;
PMID: 40029554
In clinical development, an independent data safety monitoring committee (IDMC) is often established to ensure the test treatment's integrity, quality, safety, and efficacy under investigation. In clinical trials, IDMC may...
7.
Bou-Jaoudeh M, Piaton-Breda G, Pereme F, Gilbert S
Ther Innov Regul Sci
. 2025 Feb;
PMID: 40014258
The emergence of personalized RNA therapeutics, tailored to individual patients' genetic profiles, offers new hope for treating both common and rare diseases. This review explores regulatory aspects of N-of-1 and...
8.
Picci M, Cook N, Jones B, Zhou M, Berlin C, Sturchler C, et al.
Ther Innov Regul Sci
. 2025 Feb;
PMID: 40011380
This paper describes the planning of a patient preference study for evaluating device features for the subcutaneous (SC) delivery of high dose/large volume (e.g., > 2 ml) of drugs. Multiple...
9.
Welty F, Parhofer K, Konstam M, Palmer M, Greenberg B, Daher R, et al.
Ther Innov Regul Sci
. 2025 Feb;
PMID: 40011379
In November 2007, a black box warning was mandated for rosiglitazone in type 2 diabetes mellitus (T2DM) based on an increased risk of ischemic cardiovascular (CV) events. The Food and...
10.
de Bruin A, Masullo J, Sine S, Getz K
Ther Innov Regul Sci
. 2025 Feb;
PMID: 40009138
Importance: Racially and ethnically diverse, equitable representation among clinical trial participants is important for enhancing the drug development process and promoting equitable healthcare outcomes. Objective: To understand the barriers and...