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Theragnostics in prostate cancer
The objective of this comprehensive review is to highlight the recent advances in PCa theragnostics, focusing on actual clinical applications and future perspectives.PMID:35133097 | DOI:10.23736/S1824-4785.21.03419-1 (Source: Quarterly Journal of Nuclear Medicine and Molecular Imaging)
Source: Quarterly Journal of Nuclear Medicine and Molecular Imaging - February 8, 2022 Category: Nuclear Medicine Authors: Andrea Farolfi Riccardo Mei Sakaria Ali Paolo Castellucci Source Type: research

Considerations for the Forced Expiratory Volume in 1 Second (FEV < sub > 1 < /sub > )-Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products
Clin Pharmacol Ther. 2022 Feb 8. doi: 10.1002/cpt.2553. Online ahead of print.ABSTRACTHerein, we present the U.S. Food and Drug Administration (FDA) Office of Research and Standards' current thinking, challenges, and opportunities for comparative clinical endpoint bioequivalence (BE) studies of orally inhaled drug products (OIDPs). Given the product-associated complexities of OIDPs, FDA currently uses an aggregate weight-of-evidence approach to demonstrate that a generic OIDP is bioequivalent to its reference listed drug (RLD). The approach utilizes comparative clinical endpoint BE or pharmacodynamic BE studies, pharmacoki...
Source: Clinical Pharmacology and Therapeutics - February 8, 2022 Category: Drugs & Pharmacology Authors: Jieon Lee Kairui Feng Denise S Conti Ross Walenga Michael Wientjes Hezhen Wang Bryan Newman Liangfeng Han Sneha Dhapare Elizabeth Bielski Andrew Babiskin Fang Wu Mark Donnelly Myong-Jin Kim Wenlei Jiang Markham C Luke Lanyan Fang Liang Zhao Source Type: research

Successful regulatory agency interaction - A nonclinical regulatory strategist's perspective
Regul Toxicol Pharmacol. 2022 Feb 4;130:105130. doi: 10.1016/j.yrtph.2022.105130. Online ahead of print.ABSTRACTRegulatory agency interaction occurs from before a candidate drug enters clinical development and all the way to marketing approval and beyond. This paper presents ways to enable successful interaction by avoiding issues, with an emphasis on nonclinical testing aspects. Strategic thinking as to whether an early regulatory agency meeting should occur is discussed and if yes, how to make it a success by generating relevant questions with proper preparation including a robust Briefing Document. Examples of unfavoura...
Source: Regulatory Toxicology and Pharmacology : RTP - February 8, 2022 Category: Toxicology Authors: Paul Baldrick Source Type: research

An Empirical Analysis of Japan's Drug Development Lag Behind the United States
This article is protected by copyright. All rights reserved.PMID:34970781 | DOI:10.1002/jcph.2023 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - December 31, 2021 Category: Drugs & Pharmacology Authors: Hiroshi Nakamura Naohiko Wakutsu Satoshi Murayama Takeshi Suzuki Source Type: research

Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration
This report summarizes the (1) yearly trend of submissions, (2) proportion of submissions between INDs and NDAs/BLAs, (3) percentage distribution along the stages of drug development, (4) percentage distribution across various therapeutic areas, and (5) nature of QSP applications. In brief, QSP is increasingly applied to model and simulate both drug effectiveness and safety throughout the drug development process across disease areas. (Source: CPT: Pharmacometrics and Systems Pharmacology)
Source: CPT: Pharmacometrics and Systems Pharmacology - November 4, 2021 Category: Drugs & Pharmacology Authors: Jane P. F. Bai, Justin C. Earp, Jeffry Florian, Rajanikanth Madabushi, David G. Strauss, Yaning Wang, Hao Zhu Tags: ARTICLE Source Type: research