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Think Rare, Think Inside and Out: Simple Question‐Based Approach to Complex Rare Disease Drug Development.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, p. S6, doi. 10.1002/jcph.2173
By:
- Bhattacharya, Indranil;
- Ahmed, Mariam A.
Publication type:
Article
Bridging the Gap With Clinical Pharmacology in Innovative Rare Disease Treatment Modalities: Targeting DNA to RNA to Protein.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, p. S95, doi. 10.1002/jcph.2172
By:
- Lee, Lucy;
- Gollen, Rakesh;
- Fathallah, Anas M.;
- Gao, Lan;
- Patil, Shivakumar
Publication type:
Article
Issue Information.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, p. S1, doi. 10.1002/jcph.2175
Publication type:
Article
Regulatory Framework for Drug Development in Rare Diseases.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, p. S15, doi. 10.1002/jcph.2171
By:
- Korth‐Bradley, Joan M.
Publication type:
Article
Natural History and Real‐World Data in Rare Diseases: Applications, Limitations, and Future Perspectives.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, p. S38, doi. 10.1002/jcph.2134
By:
- Liu, Jing;
- Barrett, Jeffrey S.;
- Leonardi, Efthimia T.;
- Lee, Lucy;
- Roychoudhury, Satrajit;
- Chen, Yong;
- Trifillis, Panayiota
Publication type:
Article
Immunogenicity Considerations for Therapeutic Modalities Used in Rare Diseases.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, p. S110, doi. 10.1002/jcph.2166
By:
- Fathallah, Anas M.;
- Oldfield, Philip;
- Fiedler‐Kelly, Jill;
- Ramadan, Abdulraouf
Publication type:
Article
Until My Son Calls Me Dad: Quest to Find a Treatment for Ultra‐Rare Disease.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, p. S12, doi. 10.1002/jcph.2154
By:
- Ramesh, Sanath Kumar
Publication type:
Article
Model‐Informed Approach Supporting Drug Development and Regulatory Evaluation for Rare Diseases.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, p. S27, doi. 10.1002/jcph.2143
By:
- Li, Ruo‐Jing;
- Ma, Lian;
- Li, Fang;
- Li, Liang;
- Bi, Youwei;
- Yuan, Ye;
- Li, Yangbing;
- Xu, Yuan;
- Zhang, Xinyuan;
- Liu, Jiang;
- Bhattaram, Venkatesh Atul;
- Wang, Jie;
- Schuck, Robert;
- Pacanowski, Michael;
- Zhu, Hao
Publication type:
Article
Clinical Pharmacology Considerations on Recombinant Adeno‐Associated Virus–Based Gene Therapy.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, p. S79, doi. 10.1002/jcph.2141
By:
- Sun, Kefeng;
- Liao, Michael Z.
Publication type:
Article
Overview of Clinical Pharmacology Packages of New Drug Applications Approved for the Treatment of Rare Diseases.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, p. S72, doi. 10.1002/jcph.2167
By:
- Qosa, Hisham;
- Hassan, Hazem E.;
- Younis, Islam R.
Publication type:
Article
Bayesian Complex Innovative Trial Designs (CIDs) and Their Use in Drug Development for Rare Disease.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, p. S56, doi. 10.1002/jcph.2132
By:
- Carlin, Bradley P;
- Nollevaux, Fabrice
Publication type:
Article
Gastrointestinal Bleeding During Direct Oral Anticoagulant Therapy in Patients With Nonvalvular Atrial Fibrillation and Risk of Polypharmacy.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1548, doi. 10.1002/jcph.2106
By:
- Honda, Taku;
- Abe, Koichiro;
- Oda, Minoru;
- Harada, Fumito;
- Maruyama, Kyohei;
- Aoyagi, Hitoshi;
- Miura, Ryo;
- Konno, Kumiko;
- Arizumi, Toshihiko;
- Asaoka, Yoshinari;
- Kodashima, Shinya;
- Kozuma, Ken;
- Yamamoto, Takatsugu;
- Tanaka, Atsushi
Publication type:
Article
The Importance of Diversity and Inclusion in Drug Development and Clinical Trial Conduct.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1475, doi. 10.1002/jcph.2151
By:
- Moore, Kenneth T.;
- Grundmann, Oliver;
- Iwuchukwu, Otito;
- Rakhmanina, Natella
Publication type:
Article
Using Endogenous Biomarkers to Derisk Assessment of Transporter‐Mediated Drug‐Drug Interactions: A Scientific Perspective.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1501, doi. 10.1002/jcph.2119
By:
- Arya, Vikram;
- Reynolds, Kellie S.;
- Yang, Xinning
Publication type:
Article
Drug Lawsuit Advertisements and the Importance of Physician Consultation Prior to Voluntary Medication Withdrawal or Transition.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1468, doi. 10.1002/jcph.2136
By:
- Moore, Kenneth T.;
- Pai, Sudhakar M.;
- Rogge, Mark
Publication type:
Article
The Importance of Participant Tracking When Conducting Clinical Pharmacology Drug Trials.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1465, doi. 10.1002/jcph.2135
By:
- Moore, Kenneth T.;
- Fossler, Michael J.;
- Younis, Islam
Publication type:
Article
Dosage Optimization of Lamotrigine in Pregnancy: A Pharmacometric Approach Using Modeling and Simulation.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1557, doi. 10.1002/jcph.2111
By:
- PA, Bhavatharini;
- G, Shri Sanghavi;
- Thomas, Grace;
- KP, Arun
Publication type:
Article
Leveraging a Previously Published Population Pharmacokinetic Model to Predict Rivaroxaban Exposure in Real‐World Patients.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1518, doi. 10.1002/jcph.2122
By:
- Weiner, Daniel;
- Powell, J. Robert;
- Patterson, J. Herbert;
- Tyson, Rachel;
- Gehi, Anil;
- Moll, Stephan;
- Konicki, Robyn;
- Qaraghuli, Farah Al;
- Campbell, Kristen B.;
- Kashuba, Angela D.M.;
- Gonzalez, Daniel
Publication type:
Article
Over‐the‐Counter Epinephrine for Asthma Treatment: Too Much Risk for Too Little Benefit.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1472, doi. 10.1002/jcph.2146
By:
- Gaynes, Bruce I.
Publication type:
Article
Could Active Hexose Correlated Compound (AHCC) Currently Be an Appropriate Choice to Clear Human Papillomavirus Infection?
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1576, doi. 10.1002/jcph.2118
By:
- Farasatinasab, Maryam;
- Nassiri, Setare
Publication type:
Article
Evaluation of Preoperative Risk Factors for Sugammadex‐Induced Anaphylaxis: Analysis of the Japanese Adverse Drug Event Report Database.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1574, doi. 10.1002/jcph.2114
By:
- Kotake, Kazumasa;
- Mitsuboshi, Satoru;
- Kawakami, Yasuhiro
Publication type:
Article
Thyroid Antibody Titers and Hypothalamic‐Pituitary‐Thyroid Axis Activity in Levothyroxine‐Treated Women With Autoimmune Subclinical Hypothyroidism Receiving Atorvastatin or Metformin.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1566, doi. 10.1002/jcph.2123
By:
- Krysiak, Robert;
- Kowalcze, Karolina;
- Okopień, Bogusław
Publication type:
Article
Effect Compartment Model for the Evaluation of Tolerance to Psychological Highness Following Smoking Marijuana.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1539, doi. 10.1002/jcph.2109
By:
- Singla, Sumeet;
- Block, Robert
Publication type:
Article
Bisphosphonate Use Is Not Associated With Tuberculosis Risk Among Patients With Osteoporosis: A Nationwide Cohort Study.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 11, p. 1412, doi. 10.1002/jcph.2090
By:
- Chen, Jin‐Hua;
- Lee, Chih‐Hsin;
- Lee, Meng‐Rui;
- Huang, Pei‐Yu;
- Yen, Tzu‐Hsin;
- Lee, Ming‐Chia;
- Tsai, Ching‐Wen;
- Wang, Jann‐Yuan;
- Lee, Jen‐Ai
Publication type:
Article
Population Pharmacokinetic Modeling of Lenvatinib in Chinese Patients With Advanced Hepatocellular Carcinoma Using Real‐World Data.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1507, doi. 10.1002/jcph.2103
By:
- Hu, Yingying;
- Chen, Ruijia;
- Ye, Zhenjie;
- Wei, Fuqun;
- Lin, Kecan;
- Liu, Jingfeng;
- Zeng, Yongyi
Publication type:
Article
Risk Factors for Tigecycline‐Associated Hepatotoxicity in Patients in the Intensive Care Units of 2 Tertiary Hospitals: A Retrospective Study.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 11, p. 1426, doi. 10.1002/jcph.2099
By:
- Jiang, Tingting;
- Huang, Xuhui;
- Liu, Qinghua;
- Feng, Hangwei;
- Huang, Yiting;
- Lin, Jian;
- Huang, Long;
- Chen, Shufang;
- Zhuang, Yingfeng;
- Weng, Cuilian
Publication type:
Article
Population Pharmacokinetics of Hydroxychloroquine Sulfate in Healthcare Workers, Given for Prophylaxis Against Coronavirus Disease 2019 (COVID‐19) in India.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 11, p. 1403, doi. 10.1002/jcph.2092
By:
- Raj, Jeffrey Pradeep;
- Gogtay, Nithya Jaideep;
- Pandey, Avaneesh;
- Kakkar, Ashish Kumar;
- Shafiq, Nusrat;
- Mekala, Padmaja;
- Pingali, Usharani;
- Raju, Arun Prasath;
- Mallayasamy, Surulivelrajan;
- Kshirsagar, Nilima Arun
Publication type:
Article
Pituitary Effects of Metformin in Men With Early‐Onset Androgenic Alopecia.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 11, p. 1364, doi. 10.1002/jcph.2088
By:
- Krysiak, Robert;
- Kowalcze, Karolina;
- Okopień, Bogusław
Publication type:
Article
The Impact of Suboptimal 25‐Hydroxyvitamin D Levels and Cholecalciferol Replacement on the Pharmacokinetics of Oral Midazolam in Control Subjects and Patients With Chronic Kidney Disease.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1528, doi. 10.1002/jcph.2104
By:
- Tuey, Stacey M.;
- Prebehalla, Linda;
- Roque, Amandla‐Atilano;
- Roda, Gavriel;
- Chonchol, Michel B.;
- Shah, Nirav;
- Wempe, Michael F.;
- Hu, Yichun;
- Hogan, Susan L.;
- Nolin, Thomas D.;
- Joy, Melanie S.
Publication type:
Article
ECG Evaluation as Part of the Clinical Pharmacology Strategy in the Development of New Drugs: A Review of Current Practices and Opportunities Based on Five Case Studies.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1480, doi. 10.1002/jcph.2095
By:
- Darpo, Borje;
- Borin, Marie;
- Ferber, Georg;
- Galluppi, Gerald R.;
- Hopkins, Seth C.;
- Landry, Ishani;
- Lo, Arthur;
- Rege, Bhaskar;
- Reyderman, Larisa;
- Sun, Lei;
- Watanabe, Takao;
- Xue, Hongqi;
- Yasuda, Sally
Publication type:
Article
Anaphylaxis and Related Events Following COVID‐19 Vaccination: A Systematic Review.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 11, p. 1335, doi. 10.1002/jcph.2120
By:
- Paul, Pradipta;
- Janjua, Emmad;
- AlSubaie, Mai;
- Ramadorai, Vinutha;
- Mushannen, Beshr;
- Vattoth, Ahamed Lazim;
- Khan, Wafa;
- Bshesh, Khalifa;
- Nauman, Areej;
- Mohammed, Ibrahim;
- Bouhali, Imane;
- Khalid, Mohammed;
- Zakaria, Dalia
Publication type:
Article
Issue Information.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 12, p. 1459, doi. 10.1002/jcph.1668
Publication type:
Article
A Randomized, Controlled Study to Assess Biomarkers of Exposure in Adult Smokers Switching to Oral Nicotine Products.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 11, p. 1445, doi. 10.1002/jcph.2098
By:
- Edmiston, Jeffery;
- Liu, Jianmin;
- Wang, Jingzhu;
- Sarkar, Mohamadi
Publication type:
Article
Lithium Pharmacokinetics in the Perinatal Patient With Bipolar Disorder.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 11, p. 1385, doi. 10.1002/jcph.2089
By:
- Clark, Crystal T.;
- Newmark, Rebecca L.;
- Wisner, Katherine L.;
- Stika, Catherine;
- Avram, Michael J.
Publication type:
Article
Effects of Voriconazole Exposure on the Pharmacokinetics of Tacrolimus in Lung Transplantation Patients, Based on Therapeutic Drug Monitoring Data.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 10, p. 1310, doi. 10.1002/jcph.2066
By:
- Chen, Wenqian;
- Wang, Xiaoxue;
- Li, Bo;
- Qin, Wei;
- Li, Shu;
- Wang, Xiaoxing;
- Chen, Wenhui;
- Zhang, Xianglin;
- Li, Pengmei;
- Zuo, Xianbo
Publication type:
Article
A Retrospective Analysis of Intravenous vs Oral Antibiotic Step‐Down Therapy for the Treatment of Uncomplicated Streptococcal Bloodstream Infections.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 11, p. 1372, doi. 10.1002/jcph.2097
By:
- Ramos‐Otero, Gerardo P.;
- Sarangarm, Preeyaporn;
- Walraven, Carla
Publication type:
Article
An Open‐Label, Single‐Arm, Pilot Intervention Study to Assess the Efficacy and Safety of Apixaban in Heparin‐Induced Thrombocytopenia.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 11, p. 1379, doi. 10.1002/jcph.2096
By:
- Farasatinasab, Maryam;
- Balouchzehi, Saeedeh;
- Moghaddam, Omid Moradi;
- Ansarinejad, Nafiseh;
- Mohammadi, Mahmonir;
- Nasiripour, Somayyeh
Publication type:
Article
Effects of Renal Impairment on the Pharmacokinetics of Gefapixant, a P2X3 Receptor Antagonist.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 11, p. 1435, doi. 10.1002/jcph.2094
By:
- Nussbaum, Jesse C.;
- Hussain, Azher;
- Min, K. Chris;
- Marbury, Thomas C.;
- Lasseter, Kenneth;
- Stoch, S. Aubrey;
- Iwamoto, Marian
Publication type:
Article
Drug Disposition in Subjects With Obesity: The Research Work of Darrell R. Abernethy.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 11, p. 1350, doi. 10.1002/jcph.2093
By:
- Greenblatt, David J.;
- Bruno, Christopher D.;
- Harmatz, Jerold S.;
- Zhang, Qingchen;
- Chow, Christina R.
Publication type:
Article
Physiologically Based Pharmacokinetic Modeling Approaches for Patients With SARS‐CoV‐2 Infection: A Case Study With Imatinib.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 10, p. 1285, doi. 10.1002/jcph.2065
By:
- Adiwidjaja, Jeffry;
- Adattini, Josephine A.;
- Boddy, Alan V.;
- McLachlan, Andrew J.
Publication type:
Article
Association Between Antiosteoporotic Drugs and Risk of Acute Kidney Injury: A Cross‐Sectional Study Using Disproportional Analysis and a Pharmacovigilance Database.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 11, p. 1419, doi. 10.1002/jcph.2091
By:
- Mitsuboshi, Satoru;
- Kaseda, Ryohei;
- Narita, Ichiei
Publication type:
Article
Issue Information.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 11, p. 1329, doi. 10.1002/jcph.1667
Publication type:
Article
Dapagliflozin Pharmacokinetics Is Similar in Adults With Type 1 and Type 2 Diabetes Mellitus.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 10, p. 1227, doi. 10.1002/jcph.2062
By:
- Melin, Johanna;
- Tang, Weifeng;
- Rekić, Dinko;
- Hamrén, Bengt;
- Penland, Robert C.;
- Boulton, David W.;
- Parkinson, Joanna
Publication type:
Article
Extension of the Alternative Intravenous Dosing Regimens of Atezolizumab into Combination Settings through Modeling and Simulation.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 11, p. 1393, doi. 10.1002/jcph.2074
By:
- Liu, Stephanie N.;
- Marchand, Mathilde;
- Liu, Xiaoyan;
- Ingle, Gladys;
- Maiya, Vidya;
- Graupner, Vilma;
- Elze, Markus C.;
- Chan, Phyllis;
- Hsu, Joy C.;
- Lin, Alyse;
- Vadhavkar, Shweta;
- Wu, Benjamin;
- Bruno, Rene
Publication type:
Article
"Misstatements in Artemisinin‐Based Combination Therapies in Malaria Treatment" by Fleckenstein and Miller.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 10, p. 1323, doi. 10.1002/jcph.2115
By:
- Maldonado, Joyce Hernandez;
- Grundmann, Oliver
Publication type:
Article
Misstatements in Artemisinin‐Based Combination Therapies in Malaria Treatment.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 10, p. 1321, doi. 10.1002/jcph.2113
By:
- Fleckenstein, Lawrence;
- Miller, Robert M.
Publication type:
Article
Population Pharmacokinetics of Nifurtimox in Adult and Pediatric Patients With Chagas Disease.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 10, p. 1273, doi. 10.1002/jcph.2064
By:
- Ince, Ibrahim;
- Prins, Klaas;
- Willmann, Stefan;
- Sutter, Gabriele;
- Hanze, Eva;
- Sadre‐Marandi, Farrah;
- Stass, Heino;
- Garmann, Dirk
Publication type:
Article
Drug‐Drug Interactions of Artemisinin‐Based Combination Therapies in Malaria Treatment: A Narrative Review of the Literature.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 10, p. 1197, doi. 10.1002/jcph.2073
By:
- Hernandez Maldonado, Joyce;
- Grundmann, Oliver
Publication type:
Article
The Nocebo Response in Pharmacologic Treatments of Primary Headache: A Systematic Review and Meta‐Analysis.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, n. 10, p. 1257, doi. 10.1002/jcph.2072
By:
- Zhang, Yu;
- Xu, Yingying;
- Liu, Shuping;
- Liang, Jingjing;
- Fan, Shanghua;
- Ding, Man;
- Wang, Juan;
- Xiao, Zheman
Publication type:
Article
Clinical Assessment of Fetal Well‐Being and Fetal Safety Indicators.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, p. S67, doi. 10.1002/jcph.2126
By:
- David, Anna L.;
- Spencer, Rebecca N.
Publication type:
Article

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