Výsledky vyhledávání - "Drug development"

Molecular imaging in drug development Autor Willmann, Jürgen K., van Bruggen, Nicholas, Dinkelborg, Ludger M., Gambhir, Sanjiv S.

“…Key Points Drug development is a costly, time-intensive and high-risk endeavour, with only two to three approvals for novel therapeutics in new drug classes per year eventually making it to market…”
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Inclusion of Subjects who are Obese in Drug Development: Current Status and Opportunities Autor Vaidyanathan, Jayabharathi, Fletcher, Elimika Pfuma, Ramamoorthy, Anuradha, Madabushi, Rajanikanth, Burckart, Gilbert J.

“… However, drug development programs often do not have adequate representation of individuals who are obese in clinical trials, leaving gaps in the understanding of treatment response leading to a lack…”
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Subjects treated with expanded non‐genetically modified autologous Natural Killer cells (SNK01) show improved changes in CSF α‐synuclein and in cognitive function Autor Gil, Clemente Humberto Zúñiga, Gallo, Blanca Isaura Acosta, Díaz, Rufino Menchaca, Amescua, Cesar Alejandro, Hong, Sean, Hui, Lucia, Lee, Hank, Chang, Paul, Betito, Katia, Song, Paul Y

“…Background Accumulating evidence suggests that the presynaptic protein α‐synuclein (α‐syn), is involved in the pathophysiology of AD and elevated in the…”
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Phase 1b trial on the safety, tolerability and immunogenicity of anti‐amyloid vaccine ALZ‐101 in subjects with MCI or mild AD Autor Zetterberg, Henrik, Rinne, Juha O., Sandberg, Anders, Lovró, Zsófia, Scheinin, Mika, Pierrou, Stefan, Harting, Kirsten

“…‐101 in subjects with mild AD or MCI due to AD. Methods Participants were randomised to receive placebo (n = 6), 125 µg (n = 10) or 250 µg (n = 10) doses of ALZ…”
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Phase 3 Clinical Protocol: Placebo‐Controlled, Double‐Blind, Parallel‐Group to Study Safety and Efficacy of NA‐831 in Combination with Lecanemab in Subjects with Early Alzheimer’s Disease Autor Tran, Lloyd, Tran, Zung Vu, Vu, Fern

“…Background Lecanemab has been approved by the FDA for patients with early Alzheimer’s disease (AD). NA‐831 is an experimental drug that has showed a proof of…”
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Results from COG0201: A Randomized, Double‐Blind, Placebo‐Controlled, Parallel‐ Group, Phase 2 Study to Evaluate the Safety and Efficacy of CT1812 in Subjects with Mild to Moderate Alzheimer’s Disease Autor Vijverberg, Everard G.B., Catalano, Susan, Hamby, Mary E., Grundman, Michael, Iaci, Jennifer, Devins, Theresa, Caggiano, Anthony O

“…Background CT1812 is an experimental therapeutic sigma‐2 receptor modulator in development for Alzheimer’s disease (AD) and dementia with Lewy bodies. CT1812…”
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Mitochondrial Dysfunction in Alzheimer's Disease: Opportunities for Drug Development Autor Bhatia, Shiveena, Rawal, Rishi, Sharma, Pratibha, Singh, Tanveer, Singh, Manjinder, Singh, Varinder

“…Alzheimer's disease (AD) is one of the major reasons for 60-80% cases of senile dementia occurring as a result of the accumulation of plaques and tangles in…”
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Biomarkers as drug development tools: discovery, validation, qualification and use Autor Kraus, Virginia B

“…, of qualification of drug development tools, including biomarkers and clinical outcome assessments, to increase the efficiency…”
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Dosing Recommendation Based on the Effects of Different Meal Types on Pexidartinib Pharmacokinetics in Healthy Subjects: Implementation of Model‐informed Drug Development Strategy Autor Zahir, Hamim, Yin, Ophelia, Hsu, Ching, Wagner, Andrew J., Jiang, Jason, Wang, Xiaoning, Greenberg, Jon, Shuster, Dale E., Kakkar, Tarundeep, LaCreta, Frank

“…Pexidartinib, an oral small molecule inhibitor of the colony‐stimulating factor 1 receptor, is approved for treatment of adults with symptomatic tenosynovial…”
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Model-informed drug development of Mim8 – a next-generation bispecific antibody for treatment of haemophilia A Autor Kreilgaard, Mads, Matytsina, Irina, Persson, Paula

“…•Mim8 is a next-generation activated factor VIII mimetic antibody.•Mim8 is in phase 3 trials for haemophilia A in paediatric and adult populations.•Mim8…”
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Drug Development and Safety

“…This book provides a detailed overview covering all aspects of drug development, from synthesis and manufacturing to delivery strategies, and ensuring a thorough understanding of the field…”
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Age and sex in drug development and testing for adults Autor Tannenbaum, Cara, Day, Danielle

“… This review summarizes the current state of science for considering age and sex-related factors along the drug development pipeline, from cell culture and animal research through all phases of clinical trials in humans…”
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Hepatitis B surface antigen seroclearance: Immune mechanisms, clinical impact, importance for drug development Autor Tout, Issam, Loureiro, Dimitri, Mansouri, Abdellah, Soumelis, Vassili, Boyer, Nathalie, Asselah, Tarik

“…HBsAg seroclearance occurs rarely in the natural history of chronic hepatitis B (CHB) infection and is associated with improved clinical outcomes. Many factors…”
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Making Every Subject Count: A Case Study of Drug Development Path for Medication in a Pediatric Rare Disease Autor Bhattacharya, I, Manukyan, Z, Chan, P, Harnisch, L, Heatherington, A

“…% of affected children to not live past their fifth birthday. This clear sense of urgency demands innovation and acceleration in drug development…”
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Revolutionizing Patient-Reported Outcomes Analysis for Oncology Drug Development Using Population Models Autor Zhou, Jiawei, Muluneh, Benyam, Li, Quefeng, Hughes, Jim H

“…Patient-reported outcomes (PRO) play a crucial role as clinical endpoint in oncology trials. Traditional statistical methods, such as hypothesis testing, have…”
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Discovery solubility measurement and assessment of small molecules with drug development in mind Autor Barrett, Jaclyn A., Yang, Wenzhan, Skolnik, Suzanne M., Belliveau, Lisa M., Patros, Kellyn M.

“…•Seamless solubility understanding requires discovery-development collaboration.•Gold standard methods in drug development map solubility of drug candidates…”
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Older Adults in Clinical Research and Drug Development: Closing the Geriatric Gap Autor Skolnick, Adam H, Alexander, Karen P

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Pharmacogenetic Approaches to Optimize Bioequivalence Studies in Generic Drug Development Autor Bae, Jihyun, Shon, Jihong, Kim, Myong‐Jin, Li, Karen

“…) considerations into pharmacokinetic (PK) bioequivalence (BE) study design can improve subject safety and data robustness in generic drug development…”
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Model-Informed Drug Development of the Masked Anti-PD-L1 Antibody CX-072 Autor Stroh, Mark, Green, Michelle, Millard, Bjorn L, Apgar, Joshua F, Burke, John M, Garner, Will, Lu, Hong, Lyman, Susan K, Desnoyers, Luc R, Richardson, Jennifer, Hannah, Alison, Kavanaugh, W Michael

“… Here, we report the model-informed drug development of CX-072. A quantitative systems pharmacology (QSP…”
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Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration Autor Green, Dionna J, Liu, Xiaomei I, Hua, Tianyi, Burnham, Janelle M, Schuck, Robert, Pacanowski, Michael, Yao, Lynne, McCune, Susan K, Burckart, Gilbert J, Zineh, Issam

“… The use of enrichment strategies in pediatric drug development has not been systematically assessed…”
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