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Keep an Eye on Clinical Validation Gaps in AI-Enabled Medical Devices
16 Sep 2025 21:51 GMT
… predominantly involved products lacking clinical validation and manufactured by publicly traded … to risk-based strategies in pharmacovigilance. “The association between public … include reliance on publicly available validation reports, exclusion of software …
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Physiologically Based Pharmacokinetic Modeling and Dose Optimization of Linezolid in Pediatric Patients With Renal Impairment
16 Sep 2025 19:29 GMT
… function underwent development and validation prior to its extrapolative … Developmental changes in pharmacokinetics and pharmacodynamics. J Clin Pharmacol. 2018;58 … physiological-based pharmacokinetics modeling tools. CPT Pharmacometrics Syst Pharmacol. 2023; …
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Piramal Pharma Solutions Acquires Korsch XM-12 Bilayer Tablet Press
16 Sep 2025 15:22 GMT
… technicians, while Piramal’s validation experts carry out qualification … Site Head at Piramal Pharma Solutions’ Morpeth facility. … XM-12 at Piramal Pharma Solutions’ Morpeth site … investment will help Piramal Pharma Solutions deliver innovative therapies …
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MIRA Pharmaceuticals Reports Positive PTSD Data Demonstrating Ketamir-2 Restores Normalized Behavior in Stressed Animals
16 Sep 2025 12:49 GMT
… ; September 16, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA … ;Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics … non-stressed animals. This initial validation supports the study design, and …
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Population Pharmacokinetic/Pharmacodynamic Modeling of Tacrolimus in Renal Transplant Recipients: Impact of CYP3A5 Genotype and Wuzhi Capsule Co-Medication
16 Sep 2025 09:23 GMT
… 2, and the external validation results are presented in Supplementary … validation results, we conclude that the estimated V/F remains pharmacologically … clinical implementation require further validation. Nevertheless, this study developed population …
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As the pharma industry grapples with a talent shortfall, AI makes inroads in drug-safety workflows
16 Sep 2025 04:46 GMT
… data scientists, AI scientists, validation specialists,” with regulators “effectively … use.
Filed Under: Pharmacovigilance
Tagged With: AI, … sciences, machine learning, Pharma Industry, pharmaceutical research, pharmacovigilance, regulatory affairs, talent …
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Vidac Pharma Submits Clinical Study Application to EMA for Advanced Actinic Keratosis Lesions
15 Sep 2025 05:00 GMT
… Chief Executive Officer of Vidac Pharma, commented:
“This submission … efficacy signals of Vidac Pharma’s investigational therapy in … Vidac Pharma will provide updates following EMA’s validation phase … .
Max Herzberg
Vidac pharma Holding Plc
72544257381
Visit …
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People experiencing manic episodes have measurably higher skin temperatures
17 Sep 2025 12:25 GMT
People with bipolar disorder often experience dramatic shifts in mood, energy, and behavior. A new study suggests that these psychological states may have physical signatures as well. Researchers found that individuals going through manic episodes tend to …
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Pharmaceutical Analytical Testing Market Set to Reach \$11.47 Billion by 2029, Growing at 8.7% CAGR – TBRC
15 Sep 2025 01:15 GMT
… for calibration, validation, and verification purposes in pharmaceutical labs. Take … Bioanalytical Testing, Method Development And Validation, Stability Testing, Drug Substances … By Method Development And Validation: Analytical Method Development, Analytical …
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Pharmaceutical Quality Control Market Report 2025 | Growth Opportunities, Key Drivers & Trends Through 2029
15 Sep 2025 01:15 GMT
… Shaping The Pharmaceutical Quality Control Industry?
The pharmaceutical quality control … To illustrate, Dycine Pharmaceuticals Ltd., a pharmaceutical company based in India … Services, Sterility Assurance Services, Validation And Qualification Services
3) By …