Search Results - "Gibbs, Megan"

Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor by Kasichayanula, Sreeneeranj, Grover, Anita, Emery, Maurice G., Gibbs, Megan A., Somaratne, Ransi, Wasserman, Scott M., Gibbs, John P.

“…Proprotein convertase subtilisin/kexin type 9 (PCSK9) increases plasma low-density lipoprotein cholesterol (LDL-C) by decreasing expression of the LDL receptor…”
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Clinical Pharmacology of Elagolix: An Oral Gonadotropin-Releasing Hormone Receptor Antagonist for Endometriosis by Shebley, Mohamad, Polepally, Akshanth R., Nader, Ahmed, Ng, Juki W., Winzenborg, Insa, Klein, Cheri E., Noertersheuser, Peter, Gibbs, Megan A., Mostafa, Nael M.

“…The clinical pharmacology of elagolix was extensively evaluated in clinical studies in healthy subjects and in women with endometriosis. Elagolix…”
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Quantitative Prediction of Human Pharmacokinetics for Monoclonal Antibodies: Retrospective Analysis of Monkey as a Single Species for First-in-Human Prediction by Dong, Jennifer Q., Salinger, David H., Endres, Christopher J., Gibbs, John P., Hsu, Cheng-Pang, Stouch, Brian J., Hurh, Eunju, Gibbs, Megan

“…Background and Objectives Prediction of human pharmacokinetics for monoclonal antibodies (mAbs) plays an important role for first-in-human (FIH) dose…”
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Synthetic Model Combination: A new machine‐learning method for pharmacometric model ensembling by Chan, Alexander, Peck, Richard, Gibbs, Megan, Schaar, Mihaela

“…When aiming to make predictions over targets in the pharmacological setting, a data‐focused approach aims to learn models based on a collection of labeled…”
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The potential and pitfalls of artificial intelligence in clinical pharmacology by Johnson, Martin, Patel, Mishal, Phipps, Alex, Schaar, Mihaela, Boulton, Dave, Gibbs, Megan

“…AI, artificial intelligence; ML, machine learning; PK, pharmacokinetics DOSE RECOMMENDATIONS A dose-recommender system based on AI/machine learning (ML), which…”
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Impact of Target‐Mediated Elimination on the Dose and Regimen of Evolocumab, a Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) by Gibbs, John P., Doshi, Sameer, Kuchimanchi, Mita, Grover, Anita, Emery, Maurice G., Dodds, Michael G., Gibbs, Megan A., Somaratne, Ransi, Wasserman, Scott M., Blom, Dirk

“…Understanding the pharmacokinetic (PK) and pharmacodynamic (PD) relationship of a therapeutic monoclonal antibody against proprotein convertase…”
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THE IMPACT OF P-GLYCOPROTEIN ON THE DISPOSITION OF DRUGS TARGETED FOR INDICATIONS OF THE CENTRAL NERVOUS SYSTEM: EVALUATION USING THE MDR1A/1B KNOCKOUT MOUSE MODEL by Doran, Angela, Obach, R Scott, Smith, Bill J, Hosea, Natilie A, Becker, Stacey, Callegari, Ernesto, Chen, Cuiping, Chen, Xi, Choo, Edna, Cianfrogna, Julie, Cox, Loretta M, Gibbs, John P, Gibbs, Megan A, Hatch, Heather, Hop, Cornelis E C A, Kasman, Ilana N, Laperle, Jennifer, Liu, Jianhua, Liu, Xingrong, Logman, Michael, Maclin, Debra, Nedza, Frank M, Nelson, Frederick, Olson, Emily, Rahematpura, Sandhya, Raunig, David, Rogers, Sabrinia, Schmidt, Kari, Spracklin, Douglas K, Szewc, Mark, Troutman, Matthew, Tseng, Elaine, Tu, Meihua, Van Deusen, Jeffrey W, Venkatakrishnan, Karthik, Walens, Gary, Wang, Ellen Q, Wong, Diane, Yasgar, Adam S, Zhang, Chenghong

“…Thirty-two structurally diverse drugs used for the treatment of various conditions of the central nervous system (CNS), along with two active metabolites, and…”
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A model-based meta-analysis of monoclonal antibody pharmacokinetics to guide optimal first-in-human study design by Davda, Jasmine P, Dodds, Michael G, Gibbs, Megan A, Wisdom, Wendy, Gibbs, John P

“…The objectives of this retrospective analysis were (1) to characterize the population pharmacokinetics (popPK) of four different monoclonal antibodies (mAbs)…”
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Pressurized metered-dose inhalers using next-generation propellant HFO-1234ze(E) deposit negligible amounts of trifluoracetic acid in the environment by Tewari, Shivendra G., Bell, John P., Budgen, Nigel, Platz, Stefan, Gibbs, Megan, Newham, Peter, Kimko, Holly

“…Pressurized metered-dose inhalers (pMDIs) deliver life-saving medications to patients with respiratory conditions and are the most used inhaler delivery device…”
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Quantitative Model of the Relationship Between Dipeptidyl Peptidase-4 (DPP-4) Inhibition and Response: Meta-Analysis of Alogliptin, Saxagliptin, Sitagliptin, and Vildagliptin Efficacy Results by Gibbs, John P., Fredrickson, Jill, Barbee, Todd, Correa, Itzela, Smith, Brian, Lin, Shao-Lee, Gibbs, Megan A.

“…Dipeptidyl peptidase-4 (DPP-4) inhibition is a well- characterized treatment for type 2 diabetes mellitus (T2DM). The objective of this model-based…”
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Coupling quantitative systems pharmacology modelling to machine learning and artificial intelligence for drug development: its pAIns and gAIns by Folguera-Blasco, Núria, Boshier, Florencia A. T., Uatay, Aydar, Pichardo-Almarza, Cesar, Lai, Massimo, Biasetti, Jacopo, Dearden, Richard, Gibbs, Megan, Kimko, Holly

“…Quantitative Systems Pharmacology (QSP) has become a powerful tool in the drug development landscape. To facilitate its continued implementation and to further…”
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Population pharmacokinetics of brodalumab in healthy adults and adults with psoriasis from single and multiple dose studies by Endres, Christopher J., Salinger, David H., Köck, Kathleen, Gastonguay, Marc R., Martin, David A., Klekotka, Paul, Nirula, Ajay, Gibbs, Megan A.

“…Brodalumab, a human monoclonal IgG2‐antibody, acts as a potent antagonist at the interleukin‐17 receptor A, which is important in the pathogenesis of…”
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Multiple-Dose Pharmacokinetics of the Selective Nicotinic Receptor Partial Agonist, Varenicline, in Healthy Smokers by Faessel, Hélène M., Gibbs, Megan A., Clark, David J., Rohrbacher, Kevin, Stolar, Marilyn, Burstein, Aaron H.

“…Varenicline is a novel and selective α4β2 nicotinic acetylcholine receptor partial agonist developed for smoking cessation. The primary objectives of this…”
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Population Pharmacokinetic/Pharmacodynamic Model of Subcutaneous Adipose 11β-Hydroxysteroid Dehydrogenase Type 1 (11β-HSD1) Activity After Oral Administration of AMG 221, a Selective 11β-HSD1 Inhibitor by Gibbs, John P., Emery, Maurice G., McCaffery, Ian, Smith, Brian, Gibbs, Megan A., Akrami, Anna, Rossi, John, Paweletz, Katherine, Gastonguay, Marc R., Bautista, Edgar, Wang, Minghan, Perfetti, Riccardo, Daniels, Oranee

“…Inhibition of 11β‐HSD1 is hypothesized to improve measures of insulin sensitivity and hepatic glucose output in patients with type II diabetes. AMG 221 is a…”
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Single-Dose Pharmacokinetics of Varenicline, a Selective Nicotinic Receptor Partial Agonist, in Healthy Smokers and Nonsmokers by Faessel, Hélène M., Smith, Bill J., Gibbs, Megan A., Gobey, Jason S., Clark, David J., Burstein, Aaron H.

“…Varenicline is a novel and selective α4β2 nicotinic receptor partial agonist that is under development for smoking cessation. The primary objectives of this…”
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A semi-mechanistic model to characterize the pharmacokinetics and pharmacodynamics of brodalumab in healthy volunteers and subjects with psoriasis in a first-in-human single ascending dose study by Salinger, David H., Endres, Christopher J., Martin, David A., Gibbs, Megan A.

“…Pharmacokinetic‐pharmacodynamic (PK‐PD) modeling can provide a framework for quantitative “learning and confirming” from studies in all phases of drug…”
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Central Nervous System Pharmacokinetics of the Mdr1 P-Glycoprotein Substrate CP-615,003: Intersite Differences and Implications for Human Receptor Occupancy Projections from Cerebrospinal Fluid Exposures by VENKATAKRISHNAN, Karthik, TSENG, Elaine, NELSON, Frederick R, ROLLEMA, Hans, FRENCH, Jonathan L, KAPLAN, Irina V, HORNER, Weldon E, GIBBS, Megan A

“…The central nervous system (CNS) distribution and transport mechanisms of the investigational drug candidate CP-615,003 ( N…”
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Quantitative systems modeling approaches towards model-informed drug development: Perspective through case studies by Verma, Meghna, Gall, Louis, Biasetti, Jacopo, Di Veroli, Giovanni Y., Pichardo-Almarza, Cesar, Gibbs, Megan A., Kimko, Holly

“…Quantitative systems pharmacology (QSP) modeling has become an increasingly popular approach impacting our understanding of disease mechanisms and helping…”
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Factors affecting the clinical development of cytochrome P450 3A substrates by GIBBS, Megan A, HOSEA, Natilie A

“…The objective of this review is to evaluate the risks associated with the discovery and development of cytochrome p450 (CYP) 3A substrates. CYP3A is the most…”
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Microsomal Protein Concentration Modifies the Apparent Inhibitory Potency of CYP3A Inhibitors by THANH HUU TRAN, VON MOLTKE, Lisa L, VENKATAKRISHNAN, Karthik, GRANDA, Brian W, GIBBS, Megan A, OBACH, R. Scott, HARMATZ, Jerold S, GREENBLATT, David J

“…The effect of microsomal protein concentration on the inhibitory potency of a series of CYP3A inhibitors was assessed in vitro using diazepam 3-hydroxylation…”
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