Clinical Pharmacology in Drug Development

Papers
(The TQCC of Clinical Pharmacology in Drug Development is 3. The table below lists those papers that are above that threshold based on CrossRef citation counts [max. 250 papers]. The publications cover those that have been published in the past four years, i.e., from 2022-05-01 to 2026-05-01.)
ArticleCitations
Issue Information66
Pharmacokinetics and Safety of Linezolid Tablets of 2 Different Manufacturers in Healthy Chinese Subjects in Fasting and Fed States29
Physiologically Based Pharmacokinetic Modeling to Evaluate Drug‐Drug Interactions of Tacrolimus With Ritonavir, a CYP3A Irreversible Inhibitor: Applications for Dosing Optimization in Transplant Patie26
Pharmacokinetics and Bioequivalence of the Lubiprostone Capsule in Healthy Chinese Subjects23
Pharmacokinetic and Bioequivalence Evaluation of Ulipristal Acetate in Healthy Chinese Subjects in the Fasting and Postprandial Conditions23
A Comparative Analysis of the Pharmacodynamic and Pharmacokinetic Properties of 2 Controlled‐Release Formulations Versus a Marketed Orlistat Product22
A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of TPN171 (a PDE5 Inhibitor) in Adults with Renal Impairment19
Target‐Mediated Modeling of Alirocumab in Adolescents and Children ≥8 to <12 Years of Age Using Phase II and III Data19
Pharmacokinetics of Nitazoxanide Dry Suspensions After Single Oral Doses in Healthy Subjects: Food Effects Evaluation and Bioequivalence Study18
Pharmacokinetics, Safety, and Bioequivalence of 2 Lopinavir/Ritonavir (200/50 mg) Tablets in Healthy Chinese Volunteers: Effect of Food on Absorption18
A Model‐Informed Drug Development Approach to Design a Phase 3 Trial of Teverelix Drug Product in Advanced Prostate Cancer Patients with Increased Cardiovascular Risk16
Impact of Sampling Window Variability on Pharmacokinetic Parameters Estimated by Non‐Compartmental Analysis: Case Studies of Various Types of Drugs15
A Drug‐Drug Interaction Study to Evaluate the Impact of Rimegepant on OCT2‐ and MATE1‐Mediated Transport of Metformin in Healthy Participants15
Dual Therapy Triumph: Yuquan Capsules and Metformin in Combating Type 2 Diabetes Mellitus Disorders14
A Phase 1 Bioequivalence Study to Assess the Pharmacokinetics, Safety and Tolerability of Guselkumab After a Single‐Dose Administration via Two Subcutaneous Injection Devices in Healthy Volunteers14
Taste Profile and Relative Bioavailability of Tovorafenib Powder for Oral Suspension and Food Effect of the Tovorafenib Tablet in Healthy Participants14
Phase 1 Mass Balance Study of Pizuglanstat: An Investigational Hematopoietic Prostaglandin D Synthase Inhibitor14
Evaluation of Food Effect on the Pharmacokinetics of Velufenacin, a New Muscarinic Receptor Antagonist, in Healthy Subjects13
Effect of Renal and Hepatic Impairment on the Pharmacokinetics of Pritelivir and Its Metabolites13
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Pharmacokinetics, Tolerability, and Safety of Glecaprevir/Pibrentasvir Co‐formulated Bilayer Tablet Following Repeated Administration in Healthy Chinese Adults13
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A Bioequivalence Study With Pharmacokinetic Endpoints for Azithromycin Eye Drops13
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Pharmacokinetic and Safety Comparison of Fixed‐Dose Combination of Cilostazol/Rosuvastatin (200 + 20 mg) Versus Concurrent Administration of the Separate Components in Healthy Adults13
Bioequivalence Assessment of Two Dapoxetine Hydrochloride Formulations in Healthy Chinese Males Under Fasted and Fed Conditions13
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Neonatal Fc Receptor Inhibitor Rozanolixizumab: An Ethnic Sensitivity Study in Healthy Japanese, Chinese, and White Participants12
Phase 1 Evaluation of the Bioequivalence and Drug‐Drug Interaction Potential of a Novel Fixed‐Dose Combination of Ezetimibe, Atorvastatin, and Amlodipine12
Pharmacokinetics, Safety, and Tolerability of Cedirogant in Healthy Japanese and Chinese Adults12
Combined Immediate‐Release and Extended‐Release Formulation of Sodium Valproate Provides Stable Plasma Levels for Inhibition of Histone Deacetylation12
An Open‐Label Study to Evaluate the Effect of Eluxadoline on the Single‐Dose Pharmacokinetics of Midazolam in Healthy Participants11
Strategies to Manage Dosing Deviations and Interruptions of Cabotegravir Long‐Acting Intramuscular Injections11
Safety, Tolerability, and Pharmacokinetics of Donanemab in Healthy Chinese Participants: A Phase 1, Randomized, Double‐Blind, Placebo‐Controlled Study11
ACCP Abstract Booklet11
Thorough QT Study on the Effect of Therapeutic and Supratherapeutic Dosing of Givinostat in Healthy Volunteers10
The Triple‐Agonist Revolution: Retatrutide and the Paradigm Shift in Multi‐Hormonal Pharmacotherapy for Obesity and Cardiometabolic Comorbidities10
Evaluation of Deutetrabenazine's Potential to Delay Cardiac Repolarization Using Concentration‐QTc Analysis10
A Phase 1C, Open Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of DM199 Administered Intravenously with a Polyvinyl Chloride Bag in Adult Healthy Subjec10
A Food‐Effect Study to Evaluate the Oral Bioavailability of Desidustat9
Phase 1, Single‐ and Multiple‐Ascending‐Dose, Food‐Effect, and East Asian Subject Studies to Assess the Pharmacokinetics, Safety, and Tolerability of Bempedoic Acid, a Selective Inhibitor of Adenosine9
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Impact of a High‐Fat Meal on the Pharmacokinetics of Sotorasib, a KRAS G12C Inhibitor9
Pharmacokinetics, Safety, and Tolerability of Brivaracetam in Healthy Elderly Participants9
Issue Information9
Effect of Carbamazepine on the Pharmacokinetics of Erdafitinib in Healthy Participants9
Osimertinib Efficacy and Safety in Treating Epidermal Growth Factor Receptor Mutation‐Positive Advanced Non–Small‐Cell Lung Cancer: A Meta‐Analysis8
Population Pharmacokinetic and Pharmacodynamic Modeling of Romiplostim Biosimilar GP40141 and Reference Product in Healthy Volunteers to Evaluate Biosimilarity8
Effect of Erdafitinib on the Pharmacokinetics of Midazolam and Metformin in Patients With Advanced Solid Tumors Harboring FGFR Gene Alterations8
Pharmacokinetics of Amoxicillin and Clavulanate Potassium for Suspension (200 mg/28.5 mg) in Healthy Subjects: Sample Add Stabilizer Study and Food Effects8
Issue Information8
Effects of Omeprazole and Verapamil on the Pharmacokinetics, Safety, and Tolerability of Mavacamten: Two Drug–Drug Interaction Studies in Healthy Participants8
Relative Bioavailability Studies With Mitapivat: Formulation and Food Effect Assessments in Healthy Subjects7
A Drug–Drug Interaction Study of Mobocertinib and Midazolam, a Cytochrome P450 3A Substrate, in Patients With Advanced Non–Small Cell Lung Cancer7
Three‐Period Bioequivalence Study of Sodium Levofolinate Injection With Calcium Levofolinate for Injection and Sodium Folinate for Injection in Healthy Chinese Subjects7
Pharmacokinetics, Safety, and Tolerability of a Single 5‐Day Treatment of Tirbanibulin Ointment 1% in 100 cm2: A Phase 1 Maximal‐Use Trial in Patients with Actinic Keratosis7
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Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Recombinant Neorudin, a New Anticoagulant Drug in Patients With Acute Coronary Syndrome7
Single‐Dose Pharmacokinetic Assessment of TNX‐102 SL (Cyclobenzaprine HCl Sublingual Tablets): Results From Randomized, Open‐Label Studies in Healthy Volunteers7
Extrapolation of Midazolam Disposition in Neonates Using Physiological‐Based Pharmacokinetic/Pharmacodynamic Modeling7
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Pharmacokinetics of Esomeprazole Magnesium After Single Oral Doses in Healthy Subjects: Bioequivalence Study and Food Effects7
Safety and Pharmacokinetics of a Combined Antioxidant Therapy against Myocardial Reperfusion Injury: A Phase 1 Randomized Clinical Trial in Healthy Humans7
Current Status of Weekly Insulin Analogs and Their Pharmacokinetic/Pharmacodynamic Evaluation by the Euglycemic Clamp Technique7
Bioequivalence Study of Miglitol Orally Disintegrating Tablets in Healthy Chinese Volunteers Under Fasting Condition Based on Pharmacodynamic and Pharmacokinetic Parameters7
Pharmacokinetic Evaluation of the CYP3A4 and CYP2C9 Drug‐Drug Interaction of Avacopan in 2 Open‐Label Studies in Healthy Participants7
A 2‐Part, Open‐Label, Phase 1 Bioequivalence and Food‐Effect Study of Ubrogepant in Healthy Adult Participants6
Pharmacokinetic Characteristics, Safety, and Tolerability of Telitacicept, an Injectable Recombinant Human B‐Lymphocyte Stimulating Factor Receptor‐Antibody Fusion Protein, in Healthy Chinese Subjects6
Issue Information6
Safety, Tolerability, and Pharmacokinetics of Galcanezumab, an Anti‐CGRP Antibody, in Healthy Chinese Participants6
Clinical Pharmacology of GP40321 (Insulin Glulisine Biosimilar): Pharmacokinetic and Pharmacodynamic Comparability in a Hyperinsulinemic‐Euglycemic Clamp Procedure6
Impact of Sotorasib, a KRAS G12C Inhibitor, on the Pharmacokinetics and Therapeutic Window of Digoxin, a P‐Glycoprotein Substrate6
Pharmacokinetics and Safety of Vibegron 75 mg Administered as an Intact or Crushed Tablet in Healthy Adults6
Evaluation of the Clinical Drug‐Drug Interaction Potential of Pritelivir on Transporters and CYP450 Enzymes Using a Cocktail Approach6
Authorship6
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Bioequivalence and Food Effect Assessment of Eltrombopag Olamine Tablets in Healthy Chinese Subjects: An Open, Randomized, Single‐Dose, and Two‐Period Crossover Study6
Pharmacokinetic Comparability of ABP 654, a Biosimilar to Ustekinumab, Administered Either via Prefilled Syringe or Autoinjector in Healthy Adults: Results from a Randomized, Open‐Label, Parallel‐Grou6
Clinical Impact of Antipolyethylene Glycol (PEG) Antibody in Hematological Patients Administered PEGylated‐Granulocyte Colony‐Stimulating Factor6
Population Pharmacokinetics of Tralokinumab in Adult Subjects With Moderate to Severe Atopic Dermatitis6
Safety, Tolerability, and Pharmacokinetics of Mufemilast, a PDE4 Inhibitor, in Healthy Participants: A First‐in‐Human Phase 1 Study6
Pharmacokinetics, Bioequivalence, and Safety of Levothyroxine Sodium Tablets in Healthy Chinese Subjects6
Comparative Bioavailability of Two Daily Subcutaneous Doses Versus a Single Dose of Intramuscular and Vaginal Progesterone Formulations in Healthy Postmenopausal Females6
LP‐001, a Novel Long‐Acting EPO‐Fc Fusion Protein: A Phase I Dose‐Escalation Study of Pharmacokinetics, Safety, and Tolerability in Healthy Chinese Subjects6
Population Pharmacokinetic Modeling and Simulation of Pudexacianinium (ASP5354) for Dose Setting of a Phase 2 First‐in‐Patient Study: A Novel Imaging Agent for Intraoperative Ureter Visualization duri6
Pharmacokinetics, Bioequivalence, and Safety Evaluation of Two Voriconazole Tablets in Healthy Chinese Volunteers6
Issue Information5
Pharmacokinetics and Drug–Drug Interaction of Allisartan Isoproxil and Indapamide Sustained‐Release Formulation5
Disposition and Absolute Bioavailability of Oral Imlunestrant in Healthy Women: A Phase 1, Open‐Label Study5
Effect of Itraconazole or Rifampin on Zilurgisertib Pharmacokinetics When Administered Orally in Healthy Participants5
A Randomized, Double‐Blind, Parallel Design Thorough QT Study With a Nested Crossover to Compare the Cardiac Safety of Amiselimod With Placebo and Positive Control in Healthy Volunteers5
Bioequivalence of China‐ and Germany‐Manufactured Metformin Extended‐Release Tablets Under Fed and Fasted Conditions in Healthy Volunteers: A Randomized, Open‐Label, 2‐Way Crossover Study5
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Population Pharmacokinetics Modeling and Simulation of Deutenzalutamide, A Novel Androgen Receptor Antagonist, in Patients With Metastatic Castration‐Resistant Prostate Cancer5
Issue Information5
Bioequivalence of Pomalidomide Capsules in Fasting and Fed States in Healthy Male Volunteers: A Randomized, Open, Single‐Dose, Biperiodic, Double‐Crossover Study5
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Youkenafil Hydrochloride, a Phosphodiesterase Type 5 Inhibitor, in Healthy Chinese Male Volunteers5
Cardiovascular Evaluation of Etrasimod, a Selective Sphingosine 1‐phosphate Receptor Modulator, in Healthy Adults: Results of a Randomized, Thorough QT/QTc Study5
Disposition and Mass Balance of Etrasimod in Healthy Subjects and In Vitro Determination of the Enzymes Responsible for Its Oxidative Metabolism5
Physiologically Based Pharmacokinetic Absorption Model for Pexidartinib to Evaluate the Impact of Meal Contents and Intake Timing on Drug Exposure5
Antipyretic Effect of Dexibuprofen Versus Ibuprofen in Children With Fever Caused by Upper Respiratory Tract Infection5
Pharmacokinetics of Aztreonam–Avibactam After Single‐ and Multiple‐Dose Administration: A Phase 1, Open‐Label Study in Healthy Chinese Participants and Ethnic Comparison with Non‐Chinese Participants5
No Influence of Asundexian on Cardiac Repolarization5
Absolute Bioavailability and Absorption, Distribution, Metabolism, and Excretion of [ 14 C]Xevinapant, a Potent, Oral, Small‐Molecule IAP Inhibitor5
Pharmacokinetics, Bioequivalence, and Safety of Diclofenac Sodium Sustained‐Release Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions5
An Open‐Label, Randomized Pharmacokinetic Study of 2 Formulations of Eldecalcitol Capsules Following Single Oral Administration in Healthy Chinese Volunteers Under Fasting and Fed Conditions5
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Safety, Tolerability, and Pharmacokinetics of a Novel Oral Phosphodiesterase 4 Inhibitor, ME3183: First‐in‐Human Phase 1 Study5
Pharmacokinetics of AXA1665, a Novel Composition of Amino Acids, in Comparison With Protein Supplement: A Single‐Dose, Open‐Label, Randomized Study in Healthy Subjects5
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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 Strategy5
From Reflection to Acceleration: Clinical Pharmacology’s 2025 Lessons and 2026 Opportunities5
2024 CPDD Abstract Booklet4
First‐in‐Human Study of Merotocin, a Short‐Acting Peptidic Oxytocin Receptor Agonist for Lactation Support4
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Safety, Pharmacokinetics, and Biomarkers of an Amorphous Solid Dispersion of Genistein, a Radioprotectant, in Healthy Volunteers4
Bioequivalence Study of Two Formulations of Mifepristone Tablets in Healthy Chinese Subjects Under Fasting Conditions4
Comparative Bioavailability of a Single Dose of Trametinib (TMT212) Containing 9% vs 11% Dimethyl Sulfoxide in Randomized Healthy Volunteers to Assess Long‐Term Storage at Room Temperature4
Safety and Pharmacokinetics of Single‐Dose Mirikizumab in Chinese Healthy Participants: Results From a Phase 1 Study4
Effects of Cedirogant on the Pharmacokinetics of Sensitive Cytochrome P450 Probe Substrates4
Comparative Bioequivalence and Safety Evaluation of Ibuprofen/Phenylephrine Hydrochloride Fixed‐Dose Combination Tablets in Healthy Chinese Volunteers4
Drug‐Drug Interaction Studies to Evaluate the Effect of Inhibition of UGT1A1 and CYP3A4 and Induction of CYP3A4 on the Pharmacokinetics of Tropifexor in Healthy Subjects4
SERENE ER Analysis Part 2 SERENE‐UC: Exposure‐response Analysis of Higher Versus Standard Adalimumab Dosing Regimens for Patients with Moderately to Severely Active Ulcerative Colitis4
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Optimization of Romiplostim Biosimilar Efficacy Trial Using In Silico Clinical Trial Approach for Patients With Immune Thrombocytopenia4
Pharmacokinetics of Icosapent Ethyl: An Open‐Label, Multiple Oral Dose, Parallel Design Study in Healthy Chinese Subjects4
Pharmacokinetics, Bioequivalence, and Safety Evaluation of 2 Formulations of 10‐mg Rivaroxaban Tablets: A 4‐Period Crossover Trial4
A Human Mass Balance and Metabolism Study of [ 14 C]‐Ubrogepant in Healthy Male Adults4
Effect of Dietary Intake on the Pharmacokinetics of the Multitargeted Receptor Tyrosine Kinase Inhibitor Famitinib: Results From a Phase 1 Study in Healthy Chinese Participants4
Pharmacokinetics and Bioequivalence of Amlodipine Besylate Tablet in Healthy Chinese Volunteers Under Fasting and Fed Conditions4
Comparative Bioequivalence Study of 2 Clevidipine Formulations in Healthy Chinese participants: A Single‐Dose, 2‐Period Crossover Trial4
Effect of Multiple Doses of Sparsentan on the Single‐Dose Pharmacokinetics of Dapagliflozin: An Open‐Label Drug–Drug Interaction Study in Healthy Adults4
Clinical Significance of IL‐4 and IL‐21 Concurrent Elevation in Predicting Disease Activity Score and Antihistamine Treatment Response in Chronic Spontaneous Urticaria4
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Comparison of Two Manufacturing Processes of Daprodustat for Bioequivalence and Dissolution in Healthy Volunteers: A Randomized Crossover Study4
Population Pharmacokinetic Model of N‐Acetylcysteine During Periods of Recurrent Hypoglycemia in Healthy Volunteers4
Single‐Dose Bioequivalence Study of Elagolix Tablets 200 mg (Test Product) and Elagolix Tablets 200 mg (Reference Product) in Healthy Non‐Pregnant, Non‐Lactating Premenopausal Female Subjects Under Fa4
Pharmacokinetics and bioequivalence of two N‐acetylcysteine tablets in healthy Chinese volunteers under fasting and fed conditions3
Bioequivalence Study of 2 Formulations of Fluticasone Nasal Spray in Healthy Chinese Volunteers3
A Phase 1, Randomized, Placebo‐Controlled, Multiple‐Dose, Double‐Blind Study to Evaluate and Compare the Pharmacokinetics and Safety of Rimegepant in Healthy Adult Japanese and Caucasian Individuals3
Correction to Rimegepant 75 mg in Subjects With Hepatic Impairment: Results of a Phase 1,Open‐Label, Single‐Dose, Parallel‐Group Study3
Pharmacokinetic and Bioequivalence Evaluation of Single‐Tablet and Separate‐Tablet Regimens for Ainuovirine, Lamivudine, and Tenofovir Disoproxil Fumarate in Chinese Healthy Subjects3
Safety, Tolerability, and Pharmacokinetics of IMU‐935, a Novel Inverse Agonist of Retinoic Acid Receptor–Related Orphan Nuclear Receptor γt: Results From a Double‐Blind, Placebo‐Controlled, First‐in‐H3
First‐In‐Human Study to Assess the Pharmacokinetics and Safety of DS‐6016a After Single Subcutaneous Injection in Healthy Japanese Adults3
Population Pharmacokinetics of Butylphthalide Injection in Elderly Chinese Patients With Ischemic Stroke3
Population Pharmacokinetics of Tenofovir Alafenamide Fumarate and Its Metabolite Tenofovir in Healthy Chinese Volunteers3
Evaluation of Acarbose Bioequivalence in Healthy Chinese Populations Using Novel Pharmacodynamic End Points3
Disposition and Absolute Bioavailability of Orally Administered Orforglipron in Healthy Participants3
Preclinical and Phase 1 Assessment of Antisense Oligonucleotide Bepirovirsen in Hepatitis B Virus–Transgenic Mice and Healthy Human Volunteers: Support for Clinical Dose Selection and Evaluation of Sa3
Pharmacokinetics and Food Effect Between a 100‐mg Sustained‐Release Tablet and a 50‐mg Immediate‐Release Tablet of Vildagliptin in Healthy Subjects3
Issue Information3
Absolute and Relative Bioavailability of Oral Solid Dosage Formulations of Deucravacitinib in Humans3
Pharmacokinetics and Bioequivalence of a Generic Ticagrelor 90‐mg Formulation Versus the Innovator Product in Healthy White Subjects Under Fasting Conditions3
Pharmacokinetics and Safety Evaluation of a New Generic Sitafloxacin: A Phase I Bioequivalence Study in Healthy Chinese Participants3
Comparability of Elezanumab Safety, Tolerability, and Pharmacokinetics in Healthy Japanese, Chinese, and White Participants3
Effect of Food on the Pharmacokinetics and Pharmacodynamics of a Novel Dual Delayed‐Release Formulation of Esomeprazole in Healthy Subjects3
Pharmacokinetic and Bioequivalence Evaluation of Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate, and Aspirin Tablets in Healthy Chinese Subjects in the Fasting and Postprandial Conditions3
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Effect of Cytochrome P450 3A Inhibition and Induction by Itraconazole and Rifampin on Tazemetostat Pharmacokinetics in Patients With Advanced Malignancies3
Results from a Phase 1 Study Assessing the Pharmacokinetics of the Aldosterone Synthase Inhibitor Baxdrostat in Participants with Varying Degrees of Renal Function3
Population‐Based Characterization of the Pharmacokinetics and Food Effect of ANAVEX3‐71, a Novel Sigma‐1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for Treatment of Frontote3
Evaluation of clinical cardiac safety of zilurgisertib, an activin receptor‐like kinase‐2 (ALK2) inhibitor, in healthy participants3
Bioequivalence of Meloxicam Nanocrystal Injection in Healthy Chinese Volunteers3
Steady‐State Pharmacokinetic Properties of TNX‐102 SL, a Sublingual Tablet Formulation of Cyclobenzaprine Hydrochloride (HCl), With Daily Dosing in Healthy Volunteers: A Randomized, Open‐Label Trial3
Pharmacological Parameters and Pharmacokinetic Variability Derived from Bioequivalence Trials in a Mexican Population3
Pharmacokinetics and Bioequivalence of Vardenafil Hydrochloride in Healthy Chinese Volunteers3
Issue Information3
A Single‐dose, Two‐Period Crossover Bioequivalence Study Comparing Two Liraglutide Formulations in Healthy Chinese Subjects3
Pharmacokinetics and Bioequivalence of Fudosteine in Healthy Chinese Volunteers Under Fasting and Fed Conditions: A 4‐Way Replicate Crossover Study3
Pharmacokinetics and Bioequivalence Evaluation of Trazodone Hydrochloride Sustained‐Release Tablets in Healthy Chinese Volunteers3
Population Pharmacokinetic Analysis of Valsartan in Healthy Chinese Subjects3
Pharmacokinetics, Bioequivalence, and Safety of Esomeprazole Magnesium Enteric‐Coated Capsules in Healthy Chinese Subjects3
Effect of a High‐Fat Meal on the Pharmacokinetics of an Immediate Release Atogepant Tablet3
Pharmacokinetics and Safety Study of HN0037, a Novel Anti‐Human Herpes Simplex Virus Inhibitor, in Healthy Volunteers3
Bioequivalence of Elagolix/Estradiol/Norethindrone Acetate Fixed‐Dose Combination Product: Phase 1 Results in Healthy Pre‐ and Postmenopausal Women3
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