Results 261 to 270 of about 4,643,128 (344)

Efficacy and safety of a novel sodium picosulfate oral tablet in a randomized controlled trial for bowel preparation. [PDF]

World J Gastroenterol
Park SB, Kang SB, Seo GS, Eun CS, Choi CH, Yang DH, Park JJ, Moon CM, Jung SH, Park H, Park MH, Yoo HK, Kim J, Heo JA, Park DI.   +14 more
europepmc   +1 more source

Is a Clinical Trial With a Non‐Bioequivalent Batch Necessary? The Critical Role of Intrasubject Variability in Olaparib Formulation Bridging by PBPK

Clinical Pharmacology &Therapeutics, EarlyView.
Although physiologically based pharmacokinetic (PBPK) modeling is increasingly being used to support oral drug formulation bridging, the acceptance by regulatory agencies is low. One of the primary concerns is the absence of clinical pharmacokinetic (PK) data from a non‐bioequivalent (non‐BE) batch during model validation.
Jin Dong, Andrea Moir, Xavier Pepin, Elizabeth Lowe, Sandy Hopkins, Weifeng Tang, Diansong Zhou   +6 more
wiley   +1 more source

Epilepsy Therapy Screening From 1975 to 2026 and Beyond: Merging Established and New Approaches to Develop Novel Therapies. [PDF]

Epilepsy Curr
Metcalf CS, West PJ, Smith MD, Wilcox KS.   +3 more
europepmc   +1 more source

Assessing tolerability of cancer therapeutics: A regulatory perspective from the FDA Oncology Center of Excellence. [PDF]

Cancer
Bhatnagar V, Lee Johnson L, Fiero MH, Mulkey F, Kluetz P.   +4 more
europepmc   +1 more source

Pharmacokinetics of Perampanel in Danish Paediatric Patients With Epilepsy Based on Therapeutic Drug Monitoring. [PDF]

Basic Clin Pharmacol Toxicol
Angelucci S, Houlind MB, Hansen MS, Hansen AFH, Shorter JR, Bayat A.   +5 more
europepmc   +1 more source

Retrospective analysis of the tolerability and effectiveness of rimegepant for the acute treatment of migraine in adolescents. [PDF]

Headache
Tourlas K, Ilangovan S, White C, Irwin SL, Pavitt S.   +4 more
europepmc   +1 more source

Beyond Methodological Considerations: Clinical Implications of Real-World Evidence from the CARE Study [Response to Letter]. [PDF]

J Pain Res
Überall MA, Müller-Schwefe PCG, Küster MA, Müller-Schwefe GHH.   +3 more
europepmc   +1 more source

Clobazam in Adult Drug-Resistant Epilepsy: Excellent Long-Term Retention and Potential Synergy with Neuromodulation. [PDF]

Cureus
Fang B, Haroon M, Kalantzis E, Kurukumbi M.   +3 more
europepmc   +1 more source