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Abstract: Clinical Pharmacology in Drug Development, Volume 12, Issue 11, Page 1047-1050, November 2023.
PubDate: 2023-11-01T12:13:35-07:00
DOI: 10.1002/cpdd.983
Issue No: Vol. 12, No. 11 (2023)
- Bioequivalence of 240 mg Apalutamide Tablets and Preparation in Aqueous
Food Vehicles for Alternative Administration-
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Authors:
Alex Yu; Mieke Van Uffel,
Juhui J. Jiao,
Rosamerlinda Rosales,
Maura Erba,
Nahor Haddish‐Berhane
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-11-20T11:57:40-08:00
DOI: 10.1002/cpdd.1346
- Bioequivalence and Pharmacokinetics Study of Two Zidovudine/Lamivudine
Tablets in Chinese Healthy Volunteers-
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Authors:
Xiaomei Huang; Gongzhu Wang,
Jian Huang,
Wu Liang,
Huiyu Guan,
Haisha Liu,
Yuan Deng,
Yu You,
Bikui Zhang
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-11-20T11:56:20-08:00
DOI: 10.1002/cpdd.1335
- Bioequivalence of 200 mg Amisulpride Tablets in Healthy Chinese
Volunteers under Fasting and Fed Conditions-
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Authors:
Yi Cao; Jianfen Su
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-11-20T11:55:53-08:00
DOI: 10.1002/cpdd.1348
- Effect of the Phosphate Binder Sevelamer Carbonate on the Bioavailability
of Enarodustat, an Oral Erythropoiesis Stimulating Agent-
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Authors:
Sudhakar M. Pai; Hiroyuki Yamada
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-11-17T05:04:36-08:00
DOI: 10.1002/cpdd.1336
- Bioequivalence Study of Epalrestat for Healthy Chinese Subjects
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Authors:
Dandan Yang; Xiaodan Wang,
Yi Duan,
Yichao Xu,
Zourong Ruan,
Bo Jiang,
Honggang Lou,
Jinliang Chen
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-11-16T06:18:22-08:00
DOI: 10.1002/cpdd.1347
- Support for Removing Pharmacodynamic and Clinical Efficacy Testing of
Biosimilars: A Critical Analysis-
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Authors:
Sarfaraz K. Niazi
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-11-14T07:45:46-08:00
DOI: 10.1002/cpdd.1349
- The Effect of BI 730357 (Retinoic Acid‐Related Orphan Receptor Gamma t
Antagonist, Bevurogant) on the Pharmacokinetics of a Transporter Probe
Cocktail, Including Digoxin, Furosemide, Metformin, and Rosuvastatin: An
Open‐Label, Non‐randomized, 2‐Period Fixed‐Sequence Trial in
Healthy Subjects-
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Authors:
HeeJae Choi; Fenglei Huang,
Mary Flack
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-11-13T11:31:12-08:00
DOI: 10.1002/cpdd.1344
- Population Pharmacokinetics of Tenofovir Alafenamide Fumarate and Its
Metabolite Tenofovir in Healthy Chinese Volunteers-
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Authors:
Xingfang Ji; Yunfei Li,
Zhipeng Wang,
Yuan Gao,
Ling Wang
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-11-12T11:16:46-08:00
DOI: 10.1002/cpdd.1340
- Population Pharmacokinetic Model of N‐Acetylcysteine During Periods of
Recurrent Hypoglycemia in Healthy Volunteers-
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Authors:
Mohamed S. Fayed; Jillian Brooks,
Elizabeth R. Seaquist,
Anjali Kumar,
Amir Moheet,
Lynn Eberly,
Usha Mishra,
Lisa D. Coles
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-11-08T12:48:38-08:00
DOI: 10.1002/cpdd.1338
- Pharmacokinetics and Safety Evaluation of Single‐Dose Saroglitazar
Magnesium in Subjects with Hepatic Impairment-
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Authors:
Eric Lawitz; Deven Parmar,
Taufik Momin,
Farheen Shaikh,
Harilal Patel,
Helen Hayes,
Kimberly Swint
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-11-01T01:03:59-07:00
DOI: 10.1002/cpdd.1339
- The Pharmacokinetics, Safety, and Tolerability of Rimegepant 75 mg Are
Similar in Elderly and Nonelderly Adults: A Phase 1, Open‐Label,
Parallel‐Group, Single‐Dose Study-
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Authors:
Rajinder Bhardwaj; Beth Morris,
Richard Bertz,
Robert Croop,
Jing Liu
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-10-30T11:34:48-07:00
DOI: 10.1002/cpdd.1337
- Pharmacokinetics and Drug–Drug Interaction of Allisartan Isoproxil and
Indapamide Sustained‐Release Formulation-
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Authors:
Wu Yi; Sisi Lin,
Rui Hao,
Yiming Shao,
Yannan Wang,
Jin Yu,
Lu Fang,
Jingjing Zhu,
Aiwei Wang,
Yanfang Wu,
Hua Huang,
Chongyang Deng,
Jingchao Sun,
Hongcan Zhao,
Ying Wang,
Xiangming Tong
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-10-10T02:14:19-07:00
DOI: 10.1002/cpdd.1321
- Effect of Paricalcitol Combined with Cinacalcet on Calcium and Phosphorus
Metabolism in Patients Receiving Maintenance Hemodialysis-
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Authors:
Feng‐yun Zheng; Ya‐yin Tan,
Jia‐jun Zhou
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-10-10T02:08:16-07:00
DOI: 10.1002/cpdd.1328
- Association Study of Esomeprazole Pharmacokinetics and CYP2C19 Gene
Polymorphisms-
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Authors:
Yuan Fang; Xia He,
Ai Peng,
Yi qi Yang,
Jin Xiang
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-09-29T05:49:46-07:00
DOI: 10.1002/cpdd.1334
- Effects of Omeprazole and Verapamil on the Pharmacokinetics, Safety, and
Tolerability of Mavacamten: Two Drug–Drug Interaction Studies in Healthy
Participants-
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Authors:
Vidya Perera; Daniel D. Gretler,
Julie D. Seroogy,
Manting Chiang,
Maria Palmisano,
Victoria Florea
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-09-28T11:04:41-07:00
DOI: 10.1002/cpdd.1332
- A Bioequivalence Trial of Dienogest in Healthy Chinese Participants Under
Fed Conditions-
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Authors:
Chunyan Zhao; Yuxia Wang,
Yanhua Shao
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-09-24T09:39:22-07:00
DOI: 10.1002/cpdd.1324
- Bioequivalence of Blonanserin Tablets Under Fasting and Fed Conditions in
Healthy Chinese Subjects-
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Authors:
Yuyan Lei; Yu Yan,
Junli Lu,
Chao Li,
Jie Wang,
Canxia Li,
Lifeng Huang,
Caihong Wang,
Wanying Liu,
Xiaohui Li,
Weiming Chen,
Man Xia,
Lulu Chen
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-09-23T01:23:22-07:00
DOI: 10.1002/cpdd.1331
- Effect of a High‐Fat Diet on the Pharmacokinetics and Safety of
Rivaroxaban in Healthy Chinese Subjects-
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Authors:
Xue Sun; Haojing Song,
Huan Liu,
Bo Qiu,
Congyang Ding,
Yiting Hu,
Wanjun Bai,
Zhanjun Dong
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-09-23T01:09:19-07:00
DOI: 10.1002/cpdd.1330
- Bioequivalence of Reference and Biosimilar Preparations of Premixed
Biphasic Insulin Aspart: A Comparative Clamp Study-
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Authors:
Artem Dorotenko; Igor Makarenko,
Tatiana Karonova,
Ekaterina Protsenko,
Maria Gefen,
Gagik Galstyan,
Elizaveta Antonova,
Leonid Shitov,
Yurij Dzhurko,
Roman Drai
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-09-20T04:49:09-07:00
DOI: 10.1002/cpdd.1333
- Pharmacokinetic and Bioequivalence Study of Lisinopril/Hydrochlorothiazide
Tablet Under Fasting and Postprandial Conditions in Healthy Chinese
Subjects-
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Authors:
Zhuan Yang; Xiaolan Mi,
Qin Li,
Lu Chen,
Yan Zeng,
Peng Du,
Lin Liu,
Shijing Liu,
Chen Zeng,
Qian Zhang,
Yan Zhou,
Yun Xiong,
Na Li,
Qiuyuan Ze,
Jiyu Chen,
Yan He
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-09-18T12:33:57-07:00
DOI: 10.1002/cpdd.1329
- Pharmacokinetics of Alglucosidase Alfa Manufactured at the 4000‐L Scale
in Participants with Pompe Disease: A Phase 3/4 Open‐Label Study-
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Authors:
Xavier Nicolas; Fabrice Hurbin,
Magali Periquet,
Susan Richards,
Charlotte Sensinger,
Karen Welch,
Kristina An Haack
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-09-13T11:59:19-07:00
DOI: 10.1002/cpdd.1314
- Comparison of Pharmacokinetics and Bioavailability of Fixed‐Dose
Combination Tablet and Monotherapy Combination of Allisartan Isoproxil and
Indapamide Sustained‐Release in Healthy Chinese Volunteers-
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Authors:
Ni Fan; Zhou Gongmin,
Cheng Wenming,
Yang Jiao,
Zhang Ruijie,
Chen Yan,
Tong Xiangming,
Wu Yi
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-09-10T10:30:35-07:00
DOI: 10.1002/cpdd.1327
- A Randomized Control Study in Healthy Adult Smokers to Assess Reduced
Exposure to Selected Cigarette Smoke Constituents in Switching to the
Novel Heated Tobacco Product DT3.0a-
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Authors:
Daisuke Nishihara; Dai Yuki,
Takuya Suzuki,
Chikako Sakaguchi,
Yasufumi Nagata,
Aoi Kakehi
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-09-07T11:54:05-07:00
DOI: 10.1002/cpdd.1322
- Bioequivalence of 2 Pediatric Formulations of Fexofenadine Hydrochloride
Oral Suspension-
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Authors:
Clemence Rauch; Luiz Lucio,
Beatrice Bois De Fer,
Michele Lheritier‐Barrand
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-09-01T12:56:44-07:00
DOI: 10.1002/cpdd.1311
- Comparative Pharmacokinetic Profiles of a Novel Low‐Dose Micronized
Formulation of Raloxifene 45 mg (AD‐101) and the Conventional
Raloxifene 60 mg in Healthy Subjects-
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Authors:
Hae Won Lee; Woo Youl Kang,
Mi‐Ri Gwon,
Soo‐Jin Park,
Kyunghee Cho,
Sook Jin Seong,
Young‐Ran Yoon
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-08-25T04:36:50-07:00
DOI: 10.1002/cpdd.1319
- Safety, Pharmacokinetics, and Exposure–Response Modeling of Nedosiran in
Participants With Severe Chronic Kidney Disease-
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Authors:
Aniruddha Amrite; Ernesto Fuentes,
Thomas C. Marbury,
Steven Zhang
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-08-21T10:53:10-07:00
DOI: 10.1002/cpdd.1320
- Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZY‐IL1
in Three Patients with Cryopyrin‐Associated Periodic Syndromes-
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Authors:
Pravin Hissaria; Kevinkumar Kansagra,
Hardik Patel,
Taufik Momin,
Ashok Ghoghari,
Harilal Patel,
Bhavesh Sharma
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-08-14T01:49:45-07:00
DOI: 10.1002/cpdd.1318
- Safety, Tolerability, and Pharmacokinetics of Valemetostat Tablets and the
Effect of Food on Valemetostat Pharmacokinetics in Healthy Subjects: Two
Phase 1 Studies-
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Authors:
Masaya Tachibana; Shunji Matsuki,
Kaoru Toyama,
Yutaro Maekawa,
Masato Fukae,
Takako Shimizu,
Junko Tsutsumi,
Sayaka Shinohara,
Hitoshi Ishizuka
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-08-11T04:13:45-07:00
DOI: 10.1002/cpdd.1315
- Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous
Sibeprenlimab in Healthy Participants-
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Authors:
Xiaoyan Zhang; Yanlin Wang,
Jill Yarbrough,
Mohit Mathur,
Lee Andrews,
Brian Pereira,
Susan E. Sloan,
Asher D. Schachter
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-08-11T04:13:32-07:00
DOI: 10.1002/cpdd.1316
- Changes in Urinary Uric Acid Concentration after Dotinurad Administration
to Patients with Hyperuricemia: A Post Hoc Analysis of Two Clinical Trials
in Japan-
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Authors:
Toshinari Takahashi; Minoru Sasaki,
Toru Shimizu,
Satoshi Yamaguchi
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-08-09T11:00:07-07:00
DOI: 10.1002/cpdd.1317
- Pharmacokinetics and Food Effect Between a 100‐mg Sustained‐Release
Tablet and a 50‐mg Immediate‐Release Tablet of Vildagliptin in Healthy
Subjects-
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Authors:
Hyounggyoon Yoo; Wonsuk Shin,
BackHwan Lee,
JinSoo Park,
Yilseob Lee,
Anhye Kim
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-08-07T01:42:23-07:00
DOI: 10.1002/cpdd.1313
- Pharmacokinetics and Pharmacodynamics of Burixafor Hydrobromide
(GPC‐100), a Novel C‐X‐C Chemokine Receptor 4 Antagonist and
Mobilizer of Hematopoietic Stem/Progenitor Cells, in Mice and Healthy
Subjects-
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Authors:
Devki D. Sukhtankar; Li‐wen Chang,
Cheng‐yuan Tsai,
Pina M. Cardarelli,
Niña G. Caculitan
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-08-04T02:58:23-07:00
DOI: 10.1002/cpdd.1302
- Pharmacokinetic Properties of an FDA‐approved Intranasal Nalmefene
Formulation for the Treatment of Opioid Overdose-
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Authors:
Roger Crystal; Mark Ellison,
Charlotte Purdon,
Phil Skolnick
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-07-27T12:23:26-07:00
DOI: 10.1002/cpdd.1312
- Pharmacokinetic Comparison Between a Fixed‐Dose Combination of
Empagliflozin L‐Proline/Metformin and Empagliflozin/Metformin in Healthy
Korean Subjects-
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Authors:
HyunJoon Lee; Jae‐Yong Chung,
Kyung‐Sang Yu,
Shin‐Jung Park,
Soyoung Lee
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-07-25T01:49:50-07:00
DOI: 10.1002/cpdd.1310
- Pharmacokinetic and Bioequivalence Evaluation of Two Cefprozil Dispersible
Tablets in Healthy Chinese Volunteers-
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Authors:
Lang Xu; Jianfen Su,
Halimulati Muhetaer,
Canhua Zhang,
Chen Huang,
Yukuan Tang,
Xihua Fu,
Zhimin Liang
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-07-21T05:59:50-07:00
DOI: 10.1002/cpdd.1304
- Pharmacokinetic and Bioequivalence Evaluation of Single‐Tablet and
Separate‐Tablet Regimens for Ainuovirine, Lamivudine, and Tenofovir
Disoproxil Fumarate in Chinese Healthy Subjects-
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Authors:
Lei Huang; Jing Lei,
Yuanxun Yang,
Tingting Ma,
Hui Lin,
Bei Cao,
Juan Li
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-07-20T12:24:04-07:00
DOI: 10.1002/cpdd.1309
- Comparative Bioavailability of Two Daily Subcutaneous Doses Versus a
Single Dose of Intramuscular and Vaginal Progesterone Formulations in
Healthy Postmenopausal Females-
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Authors:
Mario Tanguay; Barbara Cometti,
Sylvie Boudreault
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-07-12T11:29:05-07:00
DOI: 10.1002/cpdd.1300
- Bioequivalence of Two 6‐Mercaptopurine Tablet Formulations in Healthy
Fasting Chinese Volunteers-
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Authors:
Yaping Deng; Guohua Wang,
Guojun Jiang,
Dandan Song,
Xian Xu,
Dandan Zhao,
Guojun Tan,
Zijun Tan,
Jian Chen
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-07-05T10:56:42-07:00
DOI: 10.1002/cpdd.1298
- Bioequivalence of a Pediatric Fixed‐Dose Combination Tablet
Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Compared With
Coadministration of the Separate Agents in Healthy Adults: An
Open‐Label, Randomized, Replicate Crossover Study-
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Authors:
Sandy Van Hemelryck; Erika Van Landuyt,
Jay Ariyawansa,
Simon Vanveggel,
Martyn Palmer
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-06-19T08:14:29-07:00
DOI: 10.1002/cpdd.1293
- Bioequivalence Study of Miglitol Orally Disintegrating Tablets in Healthy
Chinese Volunteers Under Fasting Condition Based on Pharmacodynamic and
Pharmacokinetic Parameters-
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Authors:
Ming‐Xuan Zhao; Jin‐Lian Wu,
Li‐Chun Dong,
Jing Chen,
Feng‐Jia Zhu,
Yu‐Xin Fan,
Juan Zhang,
Xiao‐Ping Zhang,
Ping Zhang,
Chong‐Jing Yu,
Meng‐Di Zhou,
Jian‐Chang He
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-06-10T12:33:30-07:00
DOI: 10.1002/cpdd.1268
- Pharmacokinetic and Safety Study of Single and Multiple Oral Doses of
Safinamide in Healthy Chinese Volunteers-
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Authors:
Sun Jing; Yaozong Yuan,
Chiara Leuratti,
Valentina Vaja,
Carlo Cattaneo
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-06-09T04:29:44-07:00
DOI: 10.1002/cpdd.1277
- Bioequivalence of Celecoxib Capsules in Chinese Healthy Volunteers
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Authors:
Lichun Dong; Mingxuan Zhao,
Huiyuan Huang,
Runfang Guan,
Ruixia Li,
Yuxin Fan,
Jin Feng,
Juan Zhang,
Wenhong Zou,
Jiong Chen,
Shuxian Long,
Jianchang He
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-05-29T03:18:32-07:00
DOI: 10.1002/cpdd.1270
- Pharmacokinetics of Nifedipine‐Sustained Release Tablets in Healthy
Subjects After a Single Oral Administration: Bioequivalence Analysis and
Food Effects-
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Authors:
You‐Xuan Wu; Xue‐Feng Zhong,
Xiao‐Min Li,
Wan‐Li Liu,
Yan‐Xin Zhang,
Qiu‐Ying Shen,
Su‐Mei Xu,
Ping‐Sheng Xu
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-05-27T03:48:20-07:00
DOI: 10.1002/cpdd.1269
- Pharmacokinetics, Safety, and Tolerability of Brivaracetam in Healthy
Elderly Participants-
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Authors:
Armel Stockis; Jean‐Marie Nicolas,
Maria Laura Sargentini‐Maier,
Walter Krauwinkel
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-05-22T12:00:00-07:00
DOI: 10.1002/cpdd.1264
- Pharmacokinetics and Bioequivalence of 2 Nifedipine Controlled‐Release
Tablets: A Randomized, Single‐Dose, 2‐Period Crossover Study in
Healthy Chinese Volunteers Under Fasting and Fed Conditions-
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Authors:
Liang Xin; Qing Chen,
Dandan Chen,
Yijhen Li,
Yiqun Li,
Qingqing Wu,
Yang Zou,
Wei Wang,
Jingying Jia,
Chen Yu,
Yanmei Liu
Abstract: Clinical Pharmacology in Drug Development, EarlyView.
PubDate: 2023-05-03T02:10:20-07:00
DOI: 10.1002/cpdd.1258
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