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Elbasvir/Grazoprevir in People With Hepatitis C Genotype 1 Infection and Child-Pugh Class B Cirrhosis: The C-SALT Study.
Published in:
Clinical & Translational Gastroenterology, 2019, v. 10, n. 4, p. e00007, doi. 10.14309/ctg.0000000000000007
By:
- Jacobson, Ira M.;
- Poordad, Fred;
- Firpi-Morell, Roberto;
- Everson, Gregory T.;
- Verna, Elizabeth C.;
- Bhanja, Sanhita;
- Hwang, Peggy;
- Caro, Luzelena;
- Robertson, Michael;
- Charles, Edgar D.;
- Platt, Heather
Publication type:
Article
PK/PD Target Attainment With Ceftolozane/Tazobactam Using Monte Carlo Simulation in Patients With Various Degrees of Renal Function, Including Augmented Renal Clearance and End-Stage Renal Disease.
Published in:
2017
By:
- Xiao, Alan;
- Caro, Luzelena;
- Popejoy, Myra;
- Huntington, Jennifer;
- Kullar, Ravina
Publication type:
Report
A Phase 1 Randomized, Double‐Blind, Placebo‐Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of a Respiratory Syncytial Virus Neutralizing Monoclonal Antibody MK‐1654 in Healthy Adults.
Published in:
Clinical Pharmacology in Drug Development, 2021, v. 10, n. 5, p. 556, doi. 10.1002/cpdd.883
By:
- Aliprantis, Antonios O.;
- Wolford, Dennis;
- Caro, Luzelena;
- Maas, Brian M.;
- Ma, Hua;
- Montgomery, Diana L.;
- Sterling, Laura M.;
- Hunt, Allen;
- Cox, Kara S.;
- Vora, Kalpit A.;
- Roadcap, Brad A.;
- Railkar, Radha A.;
- Lee, Andrew W.;
- Stoch, S. Aubrey;
- Lai, Eseng
Publication type:
Article
Assessment of Drug Interaction Potential Between the Hepatitis C Virus Direct‐Acting Antiviral Agents Elbasvir/Grazoprevir and the Nucleotide Analog Reverse‐Transcriptase Inhibitor Tenofovir Disoproxil Fumarate.
Published in:
Clinical Pharmacology in Drug Development, 2019, v. 8, n. 7, p. 962, doi. 10.1002/cpdd.701
By:
- Feng, Hwa‐Ping;
- Guo, Zifang;
- Caro, Luzelena;
- Talaty, Jennifer E.;
- Mangin, Eric;
- Panebianco, Deborah;
- Fandozzi, Christine;
- Zhu, Yali;
- Marshall, William;
- Huang, Xiaobi;
- Hanley, William D.;
- Jumes, Patricia;
- Valesky, Robert;
- Martinho, Monika;
- Butterton, Joan R.;
- Iwamoto, Marian;
- Yeh, Wendy W.
Publication type:
Article
Pharmacokinetic Interactions Between the Fixed‐Dose Combinations of Elvitegravir/Cobicistat/Tenofovir Disoproxil Fumarate/Emtricitabine and Elbasvir/Grazoprevir in Healthy Adult Participants.
Published in:
Clinical Pharmacology in Drug Development, 2019, v. 8, n. 7, p. 952, doi. 10.1002/cpdd.702
By:
- Feng, Hwa‐Ping;
- Guo, Zifang;
- Fandozzi, Christine;
- Panebianco, Deborah;
- Caro, Luzelena;
- Wolford, Dennis;
- Dreyer, Daniel P.;
- Valesky, Robert;
- Martinho, Monika;
- Rizk, Matthew L.;
- Iwamoto, Marian;
- Yeh, Wendy W.
Publication type:
Article
Safety, Tolerability, and Pharmacokinetics of 3 g of Ceftolozane/Tazobactam in Healthy Adults: A Randomized, Placebo‐Controlled, Multiple‐Dose Study.
Published in:
Clinical Pharmacology in Drug Development, 2018, v. 7, n. 4, p. 382, doi. 10.1002/cpdd.429
By:
- Yu, Brian;
- Adedoyin, Adedayo;
- Hershberger, Ellie;
- Caro, Luzelena;
- Xiao, Alan;
- Rhee, Elizabeth G.;
- Huntington, Jennifer A.
Publication type:
Article
Pitavastatin is a more sensitive and selective organic anion-transporting polypeptide IB clinical probe than rosuvastatin.
Published in:
British Journal of Clinical Pharmacology, 2014, v. 78, n. 3, p. 587, doi. 10.1111/bcp.12377
By:
- Prueksaritanont, Thomayant;
- Chu, Xiaoyan;
- Evers, Raymond;
- Klopfer, Stephanie O.;
- Caro, Luzelena;
- Kothare, Prajakti A.;
- Dempsey, Cynthia;
- Rasmussen, Scott;
- Houle, Robert;
- Chan, Grace;
- Cai, Xiaoxin;
- Valesky, Robert;
- Fraser, Iain P.;
- Stoch, S. Aubrey
Publication type:
Article
A Single- and Multiple-Dose Study to Evaluate the Pharmacokinetics of Fixed-Dose Grazoprevir/Elbasvir in Healthy Chinese Participants.
Published in:
Clinical Pharmacology, 2020, v. 12, p. 1, doi. 10.2147/CPAA.S224662
By:
- Li, Haiyan;
- Yang, Zhenhua;
- Zhang, Shuang;
- Xu, Lin;
- Wei, Yudong;
- Jiang, Jun;
- Caro, Luzelena;
- Feng, Hwa-Ping;
- McCrea, Jacqueline B;
- Li, Meng;
- Xie, Shuang;
- Wang, Jiangdian;
- Zhao, Xu Min;
- Mu, Shengmei
Publication type:
Article
Pharmacokinetics of elbasvir and grazoprevir in subjects with end-stage renal disease or severe renal impairment.
Published in:
European Journal of Clinical Pharmacology, 2019, v. 75, n. 5, p. 665, doi. 10.1007/s00228-018-2585-3
By:
- Caro, Luzelena;
- Wenning, Larissa;
- Feng, Hwa-Ping;
- Guo, Zifang;
- Du, Lihong;
- Bhagunde, Pratik;
- Fandozzi, Christine;
- Panebianco, Deborah;
- Marshall, William L.;
- Butterton, Joan R.;
- Iwamoto, Marian;
- Yeh, Wendy W.
Publication type:
Article
Evaluation of Pharmacokinetic Drug Interactions of the Direct-Acting Antiviral Agents Elbasvir and Grazoprevir with Pitavastatin, Rosuvastatin, Pravastatin, and Atorvastatin in Healthy Adults.
Published in:
Clinical Drug Investigation, 2021, v. 41, n. 2, p. 133, doi. 10.1007/s40261-020-00974-8
By:
- Caro, Luzelena;
- Prueksaritanont, Thomayant;
- Fandozzi, Christine M.;
- Feng, Hwa-Ping;
- Guo, Zifang;
- Wolford, Dennis;
- Panebianco, Deborah;
- Fraser, Iain P.;
- Levine, Vanessa;
- Swearingen, Dennis;
- Butterton, Joan R.;
- Iwamoto, Marian;
- Yeh, Wendy W.
Publication type:
Article
Virologic Resistance Analysis From a Phase 2 Study of MK-5172 Combined With Pegylated Interferon/Ribavirin in Treatment-Naive Patients With Hepatitis C Virus Genotype 1 Infection.
Published in:
Clinical Infectious Diseases, 2014, v. 59, n. 12, p. 1657, doi. 10.1093/cid/ciu696
By:
- Howe, Anita Y. M.;
- Black, Stuart;
- Curry, Stephanie;
- Ludmerer, Steven W.;
- Liu, Rong;
- Barnard, Richard J. O.;
- Newhard, William;
- Hwang, Peggy M. T.;
- Nickle, David;
- Gilbert, Christopher;
- Caro, Luzelena;
- DiNubile, Mark J.;
- Mobashery, Niloufar
Publication type:
Article
Pharmacokinetics, Mass Balance, Safety, and Tolerability of Obeldesivir in Healthy Participants.
Published in:
Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1231, doi. 10.1002/cpt.3337
By:
- Anoshchenko, Olena;
- Abdelghany, Mazin;
- Lichtman, Amos;
- Duan, Ran;
- Chen, Henry;
- Shaik, Naveed A.;
- Peng, Chi‐Chi;
- Yue, Qin;
- Subramanian, Raju;
- Hyland, Robert H.;
- Davies, Santosh;
- Castellanos, Keelin;
- Mak, Lily;
- Shen, Gong;
- Xiao, Deqing;
- Caro, Luzelena;
- Winter, Helen;
- Llewellyn, Joe;
- Humeniuk, Rita
Publication type:
Article
Industrial Perspective on the Benefits Realized From the FDA's Model‐Informed Drug Development Paired Meeting Pilot Program.
Published in:
Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1172, doi. 10.1002/cpt.2265
By:
- Galluppi, Gerald R.;
- Brar, Satjit;
- Caro, Luzelena;
- Chen, Yuan;
- Frey, Nicolas;
- Grimm, Hans Peter;
- Rudd, Deanne Jackson;
- Li, Chi‐Chung;
- Magee, Mindy;
- Mukherjee, Arnab;
- Nagao, Lee;
- Purohit, Vivek S.;
- Roy, Amit;
- Salem, Ahmed Hamed;
- Sinha, Vikram;
- Suleiman, Ahmed A.;
- Taskar, Kunal S.;
- Upreti, Vijay V.;
- Weber, Benjamin;
- Cook, Jack
Publication type:
Article
Fine‐Needle Aspiration for the Evaluation of Hepatic Pharmacokinetics of Vaniprevir: A Randomized Trial in Patients With Hepatitis C Virus Infection.
Published in:
Clinical Pharmacology & Therapeutics, 2020, v. 107, n. 6, p. 1325, doi. 10.1002/cpt.1737
By:
- Gao, Wei;
- Webber, Andrea L.;
- Maxwell, Jill;
- Anderson, Melanie;
- Caro, Luzelena;
- Chung, Chris;
- Miltenburg, André M.M.;
- Popa, Serghei;
- Van Dyck, Kristien;
- Wenning, Larissa;
- Mangin, Eric;
- Fandozzi, Christine;
- Railkar, Radha;
- Shire, Norah J.;
- Fraser, Iain;
- Howell, Bonnie;
- Talal, Andrew H.;
- Stoch, S. Aubrey
Publication type:
Article
No clinically meaningful pharmacokinetic interaction between the hepatitis C virus inhibitors elbasvir and grazoprevir and the oral contraceptives ethinyl estradiol and levonorgestrel.
Published in:
European Journal of Clinical Pharmacology, 2017, v. 73, n. 5, p. 593, doi. 10.1007/s00228-017-2216-4
By:
- Marshall, William;
- Feng, Hwa-Ping;
- Caro, Luzelena;
- Talaty, Jennifer;
- Guo, Zifang;
- Huang, Xiaobi;
- Panebianco, Deborah;
- Ma, Joanne;
- Mangin, Eric;
- O'Reilly, Terry;
- Butterton, Joan;
- Yeh, Wendy
Publication type:
Article
Niacin Lipid Efficacy Is Independent of Both the Niacin Receptor GPR109A and Free Fatty Acid Suppression.
Published in:
Science Translational Medicine, 2012, v. 4, n. 148, p. 1, doi. 10.1126/scitranslmed.3003877
By:
- Lauring, Brett;
- Taggart, Andrew K. P.;
- Tata, James R.;
- Dunbar, Richard;
- Caro, Luzelena;
- Kang Cheng;
- Jayne Chin;
- Colletti, Steven L.;
- Cote, Josee;
- Khalilieh, Sauzanne;
- Jiajun Liu;
- Wen-Lin Luo;
- MacLean, Alexandra A.;
- Peterson, Laurence B.;
- Polis, Adam B.;
- Sirah, Waheeda;
- Tsuei-Ju Wu;
- Xuan Liu;
- Lan Jin;
- Kenneth Wu
Publication type:
Article
Pharmacokinetics of Oral Dexamethasone and Midazolam When Administered With Single-Dose Intravenous 150 mg Fosaprepitant in Healthy Adult Subjects.
Published in:
Journal of Clinical Pharmacology, 2011, v. 51, n. 12, p. 1712, doi. 10.1177/0091270010387792
By:
- Marbury, Thomas C.;
- Ngo, Phung L.;
- Shadle, Craig R.;
- Jin, Bo;
- Panebianco, Deborah;
- Caro, Luzelena;
- Valentine, Jack;
- Murphy, Gail
Publication type:
Article
The combination of elbasvir and grazoprevir for the treatment of chronic HCV infection in Japanese patients: a randomized phase II/III study.
Published in:
2017
By:
- Kumada, Hiromitsu;
- Suzuki, Yoshiyuki;
- Karino, Yoshiyasu;
- Chayama, Kazuaki;
- Kawada, Norifumi;
- Okanoue, Takeshi;
- Itoh, Yoshito;
- Mochida, Satoshi;
- Toyoda, Hidenori;
- Yoshiji, Hitoshi;
- Takaki, Shintaro;
- Yatsuzuka, Naoyoshi;
- Yodoya, Etsuo;
- Iwasa, Takashi;
- Fujimoto, Go;
- Robertson, Michael;
- Black, Stuart;
- Caro, Luzelena;
- Wahl, Janice;
- Robertson, Michael N
Publication type:
journal article
Pharmacokinetic Interactions Between Elbasvir/Grazoprevir and Immunosuppressant Drugs in Healthy Volunteers.
Published in:
Journal of Clinical Pharmacology, 2018, v. 58, n. 5, p. 666, doi. 10.1002/jcph.1052
By:
- Feng, Hwa‐Ping;
- Caro, Luzelena;
- Fandozzi, Christine M.;
- Guo, Zifang;
- Talaty, Jennifer;
- Wolford, Dennis;
- Panebianco, Deborah;
- Iwamoto, Marian;
- Butterton, Joan R.;
- Yeh, Wendy W.
Publication type:
Article
A phase I study to evaluate safety, pharmacokinetics, and pharmacodynamics of respiratory syncytial virus neutralizing monoclonal antibody MK‐1654 in healthy Japanese adults.
Published in:
CTS: Clinical & Translational Science, 2022, v. 15, n. 7, p. 1753, doi. 10.1111/cts.13290
By:
- Orito, Yuji;
- Otani, Naoyuki;
- Matsumoto, Yuki;
- Fujimoto, Katsukuni;
- Oshima, Nobuyuki;
- Maas, Brian M.;
- Caro, Luzelena;
- Aliprantis, Antonios O.;
- Cox, Kara S.;
- Tokumaru, Osamu;
- Kodama, Masaaki;
- Kudo, Hideo;
- Imai, Hiromitsu;
- Uemura, Naoto
Publication type:
Article
Immune‐viral dynamics modeling for SARS‐CoV‐2 drug development.
Published in:
CTS: Clinical & Translational Science, 2021, v. 14, n. 6, p. 2348, doi. 10.1111/cts.13099
By:
- Cao, Youfang;
- Gao, Wei;
- Caro, Luzelena;
- Stone, Julie A.
Publication type:
Article
No Pharmacokinetic Interactions Between Elbasvir or Grazoprevir and Buprenorphine/Naloxone in Healthy Participants and Participants Receiving Stable Opioid Agonist Therapy.
Published in:
CTS: Clinical & Translational Science, 2018, v. 11, n. 6, p. 562, doi. 10.1111/cts.12565
By:
- Feng, Hwa‐Ping;
- Guo, Zifang;
- Caro, Luzelena;
- Marshall, William L.;
- Liu, Fang;
- Panebianco, Deborah;
- Vaddady, Pavan;
- Barbour, April;
- Reitmann, Christina;
- Jumes, Patricia;
- Gilmartin, Jocelyn;
- Wolford, Dennis;
- Valesky, Robert;
- Martinho, Monika;
- Butterton, Joan R.;
- Iwamoto, Marian;
- Fraser, Iain;
- Webster, Lynn;
- Yeh, Wendy W.
Publication type:
Article
No Pharmacokinetic Interactions Between Elbasvir or Grazoprevir and Methadone in Participants Receiving Maintenance Opioid Agonist Therapy.
Published in:
CTS: Clinical & Translational Science, 2018, v. 11, n. 6, p. 553, doi. 10.1111/cts.12564
By:
- Feng, Hwa‐Ping;
- Guo, Zifang;
- Caro, Luzelena;
- Marshall, William L.;
- Liu, Fang;
- Panebianco, Deborah;
- Vaddady, Pavan;
- Reitmann, Christina;
- Jumes, Patricia;
- Wolford, Dennis;
- Fraser, Iain;
- Valesky, Robert;
- Martinho, Monika;
- Butterton, Joan R.;
- Iwamoto, Marian;
- Webster, Lynn;
- Yeh, Wendy W.
Publication type:
Article
Lung penetration, bronchopulmonary pharmacokinetic/pharmacodynamic profile and safety of 3 g of ceftolozane/tazobactam administered to ventilated, critically ill patients with pneumonia.
Published in:
2020
By:
- Caro, Luzelena;
- Nicolau, David P;
- Waele, Jan J De;
- Kuti, Joseph L;
- Larson, Kajal B;
- Gadzicki, Elaine;
- Yu, Brian;
- Zeng, Zhen;
- Adedoyin, Adedayo;
- Rhee, Elizabeth G;
- De Waele, Jan J
Publication type:
journal article
Assessment of drug interaction potential between the HCV direct-acting antiviral agents elbasvir/grazoprevir and the HIV integrase inhibitors raltegravir and dolutegravir.
Published in:
2019
By:
- Feng, Hwa-Ping;
- Guo, Zifang;
- Ross, Lisa L;
- Fraser, Iain;
- Panebianco, Deborah;
- Jumes, Patricia;
- Fandozzi, Christine;
- Caro, Luzelena;
- Talaty, Jennifer;
- Ma, Joanne;
- Mangin, Eric;
- Huang, Xiaobi;
- Marshall, William L;
- Butterton, Joan R;
- Iwamoto, Marian;
- Yeh, Wendy W
Publication type:
journal article
Safety and efficacy of elbasvir/grazoprevir in Asian participants with hepatitis C virus genotypes 1 and 4 infection.
Published in:
Journal of Gastroenterology & Hepatology, 2019, v. 34, n. 9, p. 1597, doi. 10.1111/jgh.14636
By:
- Wei, Lai;
- Kumada, Hiromitsu;
- Perumalswami, Ponni V;
- Tanwandee, Tawesak;
- Cheng, Wendy;
- Heo, Jeong;
- Cheng, Pin‐Nan;
- Hwang, Peggy;
- Mu, Sheng Mei;
- Zhao, Xu Min;
- Asante‐Appiah, Ernest;
- Caro, Luzelena;
- Hanna, George J;
- Robertson, Michael N;
- Haber, Barbara A;
- Talwani, Rohit
Publication type:
Article

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