Results 241 to 250 of about 39,175 (290)

Safety assessment of biopharmaceuticals: Japanese perspective on ICH S6 guideline maintenance

, 2008
Takahiro Nakazawa, Misao Kurokawa, Kazuya Kimura, Akihiro Wakata, Shigeru Hisada, Tadashi Inoue, Fumio Sagami, Shawn M. Heidel, Koji Kawakami, Kazutoshi Shinoda, Hiroshi Onodera, Yuji Kumagai, Yasuo Ohno, Nobuyuki Kawamura, T. Yamazaki, Tohru Inoue   +15 more
openalex   +2 more sources

Advancing pharmacometrics in Africa—Transition from capacity development toward job creation

CPT: Pharmacometrics &Systems Pharmacology, Volume 14, Issue 3, Page 407-419, March 2025.
Abstract Trained pharmacometricians remain scarce in Africa due to limited training opportunities, lack of a pharmaceutical product development ecosystem, and emigration to high‐income countries. The Applied Pharmacometrics Training (APT) fellowship program was established to address these gaps and specifically foster job creation for talent retention.
Goonaseelan (Colin) Pillai, Samer Mouksassi, Innocent G. Asiimwe, Craig R. Rayner, Steven Kern, Phumla Sinxadi, Paolo Denti, Eric Decloedt, Catriona Waitt, Bernhards R. Ogutu, Rik de Greef   +10 more
wiley   +1 more source

Considering Opportunities and Challenges When Implementing the Model Master File Framework - a Meeting Report. [PDF]

Pharm Res
Tsakalozou E, Fang L, Skoda E, Nicholas T, Kollipara S, Ren K, Grosser S, Rege B, Roy P, Zhu H, Zhao L.   +10 more
europepmc   +1 more source

Modeling of Disease Progression of Type 2 Diabetes Using Real‐World Data: Quantifying Competing Risks of Morbidity and Mortality

CPT: Pharmacometrics &Systems Pharmacology, Volume 14, Issue 3, Page 606-615, March 2025.
ABSTRACT Type 2 diabetes (T2D) is a progressive metabolic disorder that could be an underlying cause of long‐term complications that increase mortality. The assessment of the probability of such events could be essential for mortality risk management. This work aimed to establish a framework for risk predictions of macrovascular complications (MVC) and
Hanna Kunina, Stefan Franzén, Maria C. Kjellsson   +2 more
wiley   +1 more source

Understanding the mechanisms of food effect on omaveloxolone pharmacokinetics through physiologically based biopharmaceutics modeling. [PDF]

CPT Pharmacometrics Syst Pharmacol
Pepin XJH, Hynes SM, Zahir H, Walker D, Semmens LQ, Suarez-Sharp S.   +5 more
europepmc   +1 more source

A Combined Modeling Approach to Predict the Effect of Gastric Emptying Delay on the Pharmacokinetics of Small Molecules

CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
ABSTRACT Dulaglutide, a long‐acting glucagon‐like peptide‐1 (GLP‐1) receptor agonist, is approved for improving glycemic control and reducing cardiovascular risks in patients with type 2 diabetes mellitus (T2DM). This research investigates the effect of dulaglutide on gastric emptying and its impact on the pharmacokinetics (PK) of orally administered ...
Maria M. Posada, Karen B. Schneck, Bridget L. Morse, Luc R. A. Rougee, Lai San Tham, Jessica F. Rehmel, Brian Thompson, Stephen D. Stamatis, Stephen D. Hall, Gemma L. Dickinson   +9 more
wiley   +1 more source

Development and Optimization of a Novel Synthetic Route for 2,4-Diamine-quinazoline Containing Ziresovir: A Drug Candidate for the Treatment of Respiratory Syncytial Virus (RSV) Infection. [PDF]

ACS Omega
You C, Wang D, He C, Zaman MK, Zhang H, Wang T, Yang Z, Hu L, Li Y.   +8 more
europepmc   +1 more source

An Open‐Source Framework for Virtual Bioequivalence Modeling and Clinical Trial Design

CPT: Pharmacometrics &Systems Pharmacology, EarlyView.
ABSTRACT To establish bioequivalence (BE) of a generic test formulation with respect to a reference listed drug, it is necessary to demonstrate a comparable rate and extent to which active ingredients reach the site of action. To decrease unnecessary human testing and simulate scenarios involving specific populations or challenges with recruitment or ...
Abdullah Hamadeh, Moriah Pellowe, Pierre Chelle, Cindy Hoi Ting Yeung, Julian Otalvaro, Walter Yamada, Jay Bartroff, Alona Kryshchenko, André Dallmann, Juri Solodenko, Jörg Lippert, Eleftheria Tsakalozou, Michael Neely, Andrea Edginton   +13 more
wiley   +1 more source

Water Activity as an Indicator for Antibody Storage Stability in Lyophilized Formulations. [PDF]

Mol Pharm
Zäh M, Brandenbusch C, Groël S, Winter G, Sadowski G.   +4 more
europepmc   +1 more source

Jujuboside B Induces Ferroptosis and Overcomes Radioresistance Through the PPARγ‐ATF3‐Gpx4 Signaling Pathway in Non‐Small Cell Lung Cancer

Phytotherapy Research, EarlyView.
Jujuboside B induces ferroptosis and overcomes radioresistance. ABSTRACT Jujuboside B (JJB) is a saponin extracted from the Ziziphus jujuba var. spinose and has been reported to have anticancer effects. However, the detailed mechanism of its anti‐cancer effect in non‐small cell lung cancer (NSCLC) remains unclear.
Tae Woo Kim, Seong‐Gyu Ko
wiley   +1 more source