OOIR: Observatory of International Research

Papers

(The median citation count of Clinical Pharmacology in Drug Development is 1. 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 2021-05-01 to 2025-05-01.)

Article	Citations
Pharmacokinetics of Nitazoxanide Dry Suspensions After Single Oral Doses in Healthy Subjects: Food Effects Evaluation and Bioequivalence Study	39
Issue Information	31
Pharmacokinetics, Safety, and Bioequivalence of 2 Lopinavir/Ritonavir (200/50 mg) Tablets in Healthy Chinese Volunteers: Effect of Food on Absorption	27
Phase 1 Mass Balance Study of Pizuglanstat: An Investigational Hematopoietic Prostaglandin D Synthase Inhibitor	22
Pharmacokinetics and Safety of Linezolid Tablets of 2 Different Manufacturers in Healthy Chinese Subjects in Fasting and Fed States	22
A Drug‐Drug Interaction Study to Evaluate the Impact of Rimegepant on OCT2‐ and MATE1‐Mediated Transport of Metformin in Healthy Participants	20
Bioequivalence of Esaxerenone Conventional Tablet and Orally Disintegrating Tablet: Two Single‐Dose Crossover Studies in Healthy Japanese Men	19
A Model‐Informed Drug Development Approach to Design a Phase 3 Trial of Teverelix Drug Product in Advanced Prostate Cancer Patients with Increased Cardiovascular Risk	17
Bioequivalence Assessment of Two Dapoxetine Hydrochloride Formulations in Healthy Chinese Males Under Fasted and Fed Conditions	16
Apixaban Single‐Dose Pharmacokinetics, Bioavailability, Renal Clearance, and Pharmacodynamics Following Intravenous and Oral Administration	16
A Comparative Analysis of the Pharmacodynamic and Pharmacokinetic Properties of 2 Controlled‐Release Formulations Versus a Marketed Orlistat Product	15
A Phase I Study to Evaluate the Pharmacokinetics and Safety of TPN171 (a PDE5 Inhibitor) in Adults with Renal Impairment	15
Pharmacokinetics and Bioequivalence of the Lubiprostone Capsule in Healthy Chinese Subjects	15
Phase 1 Study Evaluating the Effects of the Proton Pump Inhibitor Rabeprazole and Food on the Pharmacokinetics of Lorlatinib in Healthy Participants	15
Target‐Mediated Modeling of Alirocumab in Adolescents and Children ≥8 to <12 Years of Age Using Phase II and III Data	14
Bioequivalence Evaluation Between Acarbose and Metformin Fixed‐Dose Combination and Corresponding Individual Components in Healthy Chinese Male and Female Subjects	14
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 Adenosine	13
An Open‐Label Study to Evaluate the Effect of Eluxadoline on the Single‐Dose Pharmacokinetics of Midazolam in Healthy Participants	12
Pharmacokinetics, Tolerability, and Safety of Glecaprevir/Pibrentasvir Co‐formulated Bilayer Tablet Following Repeated Administration in Healthy Chinese Adults	12
Evaluation of Food Effect on the Pharmacokinetics of Velufenacin, a New Muscarinic Receptor Antagonist, in Healthy Subjects	12
A Bioequivalence Study With Pharmacokinetic Endpoints for Azithromycin Eye Drops	12
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 Subjec	11
Evaluation of Deutetrabenazine's Potential to Delay Cardiac Repolarization Using Concentration‐QTc Analysis	11
Effect of Carbamazepine on the Pharmacokinetics of Erdafitinib in Healthy Participants	11
	11

Effect of Renal and Hepatic Impairment on the Pharmacokinetics of Pritelivir and Its Metabolites	11
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Pharmacokinetics, Safety, and Tolerability of Cedirogant in Healthy Japanese and Chinese Adults	10
Pharmacokinetics, Safety, and Tolerability of Brivaracetam in Healthy Elderly Participants	10
Phase 1 Evaluation of the Bioequivalence and Drug‐Drug Interaction Potential of a Novel Fixed‐Dose Combination of Ezetimibe, Atorvastatin, and Amlodipine	10
Effect of Phosphate Binders and a Dietary Iron Supplement on the Pharmacokinetics of a Single Dose of Vadadustat in Healthy Adults	10
Update on ICH E14/S7B Cardiac Safety Regulations: The Expanded Role of Preclinical Assays and the “Double‐Negative” Scenario	10
ACCP Abstract Booklet	10
Pharmacokinetics and Safety of the Nucleoside Analog Antiviral Drug Galidesivir Administered to Healthy Adult Subjects	9
Bioequivalence and Food Effect Assessment of 2 Rivaroxaban Formulations in Healthy Chinese Volunteers: An Open, Randomized, Single‐Dose, and 4‐Period Crossover Study	9
Issue Information	9
Pharmacokinetic and Safety Comparison of Fixed‐Dose Combination of Cilostazol/Rosuvastatin (200 + 20 mg) Versus Concurrent Administration of the Separate Components in Healthy Adults	9
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Neonatal Fc Receptor Inhibitor Rozanolixizumab: An Ethnic Sensitivity Study in Healthy Japanese, Chinese, and White Participants	9
A Food‐Effect Study to Evaluate the Oral Bioavailability of Desidustat	9
Pharmacokinetics and Bioequivalence Study of a New Branded Generic Moxifloxacin Tablet Among Healthy Volunteers	9
	9
Current Status of Weekly Insulin Analogs and Their Pharmacokinetic/Pharmacodynamic Evaluation by the Euglycemic Clamp Technique	8
Issue Information	8
Issue Information	8
Osimertinib Efficacy and Safety in Treating Epidermal Growth Factor Receptor Mutation‐Positive Advanced Non–Small‐Cell Lung Cancer: A Meta‐Analysis	8
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 Keratosis	8
Three‐Period Bioequivalence Study of Sodium Levofolinate Injection With Calcium Levofolinate for Injection and Sodium Folinate for Injection in Healthy Chinese Subjects	8
Pharmacokinetics, Safety, and Pharmacodynamics of Romiplostim in Chinese Subjects With Immune Thrombocytopenia: A Phase I/II Trial	8
Population Pharmacokinetic and Pharmacodynamic Modeling of Romiplostim Biosimilar GP40141 and Reference Product in Healthy Volunteers to Evaluate Biosimilarity	8
Effects of Omeprazole and Verapamil on the Pharmacokinetics, Safety, and Tolerability of Mavacamten: Two Drug–Drug Interaction Studies in Healthy Participants	8
Extrapolation of Midazolam Disposition in Neonates Using Physiological‐Based Pharmacokinetic/Pharmacodynamic Modeling	8
Pharmacokinetic Evaluation of the CYP3A4 and CYP2C9 Drug‐Drug Interaction of Avacopan in 2 Open‐Label Studies in Healthy Participants	8
Bioequivalence Study of Miglitol Orally Disintegrating Tablets in Healthy Chinese Volunteers Under Fasting Condition Based on Pharmacodynamic and Pharmacokinetic Parameters	8
Effect of Erdafitinib on the Pharmacokinetics of Midazolam and Metformin in Patients With Advanced Solid Tumors Harboring FGFR Gene Alterations	8
Pharmacokinetics of Amoxicillin and Clavulanate Potassium for Suspension (200 mg/28.5 mg) in Healthy Subjects: Sample Add Stabilizer Study and Food Effects	8
Impact of a High‐Fat Meal on the Pharmacokinetics of Sotorasib, a KRAS G12C Inhibitor	8
Evaluation of the Effects of Repeat‐Dose Dabrafenib on the Single‐Dose Pharmacokinetics of Rosuvastatin (OATP1B1/1B3 Substrate) and Midazolam (CYP3A4 Substrate)	7
	7
Relative Bioavailability Studies With Mitapivat: Formulation and Food Effect Assessments in Healthy Subjects	7
List of Reviewers 2021	7
Issue Information	7
Authorship	7
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 duri	6
Pharmacokinetic Characteristics, Safety, and Tolerability of Telitacicept, an Injectable Recombinant Human B‐Lymphocyte Stimulating Factor Receptor‐Antibody Fusion Protein, in Healthy Chinese Subjects	6
Bioequivalence and Food Effect Assessment of Eltrombopag Olamine Tablets in Healthy Chinese Subjects: An Open, Randomized, Single‐Dose, and Two‐Period Crossover Study	6
Pharmacokinetics and Bioequivalence Studies of Roxatidine Acetate Hydrochloride Sustained‐Release Capsule in Healthy Chinese Subjects	6
Evaluation of the Pharmacokinetic Interaction and Safety of Ubrogepant Coadministered With Esomeprazole Magnesium	6
Evaluation of the Clinical Drug‐Drug Interaction Potential of Pritelivir on Transporters and CYP450 Enzymes Using a Cocktail Approach	6
Pharmacokinetics of Esomeprazole Magnesium After Single Oral Doses in Healthy Subjects: Bioequivalence Study and Food Effects	6
Population Pharmacokinetics of Tralokinumab in Adult Subjects With Moderate to Severe Atopic Dermatitis	6
Clinical Pharmacology of GP40321 (Insulin Glulisine Biosimilar): Pharmacokinetic and Pharmacodynamic Comparability in a Hyperinsulinemic‐Euglycemic Clamp Procedure	6
Phase 1 Studies to Evaluate the Food Effect and Relative Bioavailability of Tablet and Capsule Formulations of Belumosudil in Healthy Adult Subjects	6
Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Recombinant Neorudin, a New Anticoagulant Drug in Patients With Acute Coronary Syndrome	6
Population Pharmacokinetic Modeling and Exposure‐Response Analysis for Aripiprazole Once Monthly in Subjects With Schizophrenia	6
Comparative Bioavailability of Two Daily Subcutaneous Doses Versus a Single Dose of Intramuscular and Vaginal Progesterone Formulations in Healthy Postmenopausal Females	6

Cardiovascular Evaluation of Etrasimod, a Selective Sphingosine 1‐phosphate Receptor Modulator, in Healthy Adults: Results of a Randomized, Thorough QT/QTc Study	6
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A Drug–Drug Interaction Study of Mobocertinib and Midazolam, a Cytochrome P450 3A Substrate, in Patients With Advanced Non–Small Cell Lung Cancer	6
Impact of Sotorasib, a KRAS G12C Inhibitor, on the Pharmacokinetics and Therapeutic Window of Digoxin, a P‐Glycoprotein Substrate	6
Safety and Pharmacokinetics of a Combined Antioxidant Therapy against Myocardial Reperfusion Injury: A Phase 1 Randomized Clinical Trial in Healthy Humans	6
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 Subjects	5
Issue Information	5
Dosing Recommendation Based on the Effects of Different Meal Types on Pexidartinib Pharmacokinetics in Healthy Subjects: Implementation of Model‐informed Drug Development Strategy	5
Safety, Pharmacokinetics, and Pharmacodynamics of Oral Insulin Administration in Healthy Subjects: A Randomized, Double‐Blind, Phase 1 Trial	5
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 Volunteers	5
Clinical Impact of Antipolyethylene Glycol (PEG) Antibody in Hematological Patients Administered PEGylated‐Granulocyte Colony‐Stimulating Factor	5
Pharmacokinetics and Drug–Drug Interaction of Allisartan Isoproxil and Indapamide Sustained‐Release Formulation	5
Antipyretic Effect of Dexibuprofen Versus Ibuprofen in Children With Fever Caused by Upper Respiratory Tract Infection	5
Issue Information	5
Effect of Multiple Doses of Sparsentan on the Single‐Dose Pharmacokinetics of Dapagliflozin: An Open‐Label Drug–Drug Interaction Study in Healthy Adults	5
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 Study	5
Physiologically Based Pharmacokinetic Absorption Model for Pexidartinib to Evaluate the Impact of Meal Contents and Intake Timing on Drug Exposure	5
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Youkenafil Hydrochloride, a Phosphodiesterase Type 5 Inhibitor, in Healthy Chinese Male Volunteers	5
No Influence of Asundexian on Cardiac Repolarization	5
Pharmacokinetics of a Fixed‐Dose Combination of Amlodipine/Losartan and Chlorthalidone Compared to Concurrent Administration of the Separate Components	5
Absolute Bioavailability, Mass Balance, and Metabolic Profiling Assessment of [¹⁴C]‐Belumosudil in Healthy Men: A Phase 1, Open‐Label, 2‐Part Study	5
Disposition and Mass Balance of Etrasimod in Healthy Subjects and In Vitro Determination of the Enzymes Responsible for Its Oxidative Metabolism	5
2024 CPDD Abstract Booklet	5
Pharmacokinetics of AXA1665, a Novel Composition of Amino Acids, in Comparison With Protein Supplement: A Single‐Dose, Open‐Label, Randomized Study in Healthy Subjects	5
Optimization of Romiplostim Biosimilar Efficacy Trial Using In Silico Clinical Trial Approach for Patients With Immune Thrombocytopenia	5
Bioequivalence of Pomalidomide Capsules in Fasting and Fed States in Healthy Male Volunteers: A Randomized, Open, Single‐Dose, Biperiodic, Double‐Crossover Study	5
Pharmacokinetics and Bioequivalence of 2 Azithromycin Tablet Formulations: A Randomized, Open‐Label, 2‐Stage Crossover Study in Healthy Volunteers	5
Population Pharmacokinetics Modeling and Simulation of Deutenzalutamide, A Novel Androgen Receptor Antagonist, in Patients With Metastatic Castration‐Resistant Prostate Cancer	5
An Open‐Label, Randomized Pharmacokinetic Study of 2 Formulations of Eldecalcitol Capsules Following Single Oral Administration in Healthy Chinese Volunteers Under Fasting and Fed Conditions	5
Pharmacokinetics and Safety of Vibegron 75 mg Administered as an Intact or Crushed Tablet in Healthy Adults	5
Safety, Tolerability, and Pharmacokinetics of a Novel Oral Phosphodiesterase 4 Inhibitor, ME3183: First‐in‐Human Phase 1 Study	5
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 Colitis	5
Pharmacokinetics and Bioequivalence of Amlodipine Besylate Tablet in Healthy Chinese Volunteers Under Fasting and Fed Conditions	5
Thorough QT/QTc Evaluation of the Cardiac Safety of Enarodustat (JTZ‐951), an Oral Erythropoiesis‐Stimulating Agent, in Healthy Adults	5
Effects of Unsuppressed Endogenous Insulin on Pharmacokinetics and/or Pharmacodynamics of Study Insulin in the Healthy: A Retrospective Study	4
Pharmacokinetics and Bioequivalence of a Generic Ticagrelor 90‐mg Formulation Versus the Innovator Product in Healthy White Subjects Under Fasting Conditions	4
A Phase 1, Open‐Label Study to Evaluate the Effect of Food and Concomitant Itraconazole Administration on the Pharmacokinetics of AMG 986 in Healthy Subjects	4
Bioequivalence of Elagolix/Estradiol/Norethindrone Acetate Fixed‐Dose Combination Product: Phase 1 Results in Healthy Pre‐ and Postmenopausal Women	4
Pharmacokinetics, Safety, and Tolerability of Letermovir Following Single‐ and Multiple‐Dose Administration in Healthy Japanese Subjects	4
Population Pharmacokinetic Model of N‐Acetylcysteine During Periods of Recurrent Hypoglycemia in Healthy Volunteers	4
Pharmacokinetic and Bioequivalence Evaluation of Single‐Tablet and Separate‐Tablet Regimens for Ainuovirine, Lamivudine, and Tenofovir Disoproxil Fumarate in Chinese Healthy Subjects	4
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Effect of Dietary Intake on the Pharmacokinetics of the Multitargeted Receptor Tyrosine Kinase Inhibitor Famitinib: Results From a Phase 1 Study in Healthy Chinese Participants	4
Pharmacokinetic and Bioequivalence Evaluation of Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate, and Aspirin Tablets in Healthy Chinese Subjects in the Fasting and Postprandial Conditions	4
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 Frontote	4
Bioequivalence Study of 2 Formulations of Fluticasone Nasal Spray in Healthy Chinese Volunteers	4
Bioequivalence of Meloxicam Nanocrystal Injection in Healthy Chinese Volunteers	4
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 Sa	4
Pharmacokinetics, Bioequivalence, and Safety Studies of Amlodipine Besylate in Healthy Subjects	4
Correction to Rimegepant 75 mg in Subjects With Hepatic Impairment: Results of a Phase 1,Open‐Label, Single‐Dose, Parallel‐Group Study	4
Phase 1 Maximal Use Pharmacokinetic Study of Tirbanibulin Ointment 1% in Subjects With Actinic Keratosis	4
Pharmacokinetics and Food Effect Between a 100‐mg Sustained‐Release Tablet and a 50‐mg Immediate‐Release Tablet of Vildagliptin in Healthy Subjects	4
Pharmacokinetics, Bioequivalence, and Safety Evaluation of 2 Formulations of 10‐mg Rivaroxaban Tablets: A 4‐Period Crossover Trial	4
Comparability of Elezanumab Safety, Tolerability, and Pharmacokinetics in Healthy Japanese, Chinese, and White Participants	4
Bioequivalence Study of Two Formulations of Mifepristone Tablets in Healthy Chinese Subjects Under Fasting Conditions	4
A Pharmacokinetic Bioequivalence Study Comparing Different‐Strength and ‐Size Capsules of Isavuconazonium Sulfate in Healthy Japanese Subjects	4
Safety and Pharmacokinetics of Single‐Dose Mirikizumab in Chinese Healthy Participants: Results From a Phase 1 Study	4
Pharmacokinetics and Bioequivalence of Vardenafil Hydrochloride in Healthy Chinese Volunteers	4
Pharmacokinetics, Bioequivalence, and Safety of Esomeprazole Magnesium Enteric‐Coated Capsules in Healthy Chinese Subjects	4
Effect of Food on the Pharmacokinetics and Pharmacodynamics of a Novel Dual Delayed‐Release Formulation of Esomeprazole in Healthy Subjects	4
Issue Information	4
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‐H	4
A Single‐dose, Two‐Period Crossover Bioequivalence Study Comparing Two Liraglutide Formulations in Healthy Chinese Subjects	4
Absolute and Relative Bioavailability of Oral Solid Dosage Formulations of Deucravacitinib in Humans	4
Pharmacological Parameters and Pharmacokinetic Variability Derived from Bioequivalence Trials in a Mexican Population	4
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 Temperature	4
Comparison of Two Manufacturing Processes of Daprodustat for Bioequivalence and Dissolution in Healthy Volunteers: A Randomized Crossover Study	4
Safety, Pharmacokinetics, and Biomarkers of an Amorphous Solid Dispersion of Genistein, a Radioprotectant, in Healthy Volunteers	4
Pharmacokinetics of Icosapent Ethyl: An Open‐Label, Multiple Oral Dose, Parallel Design Study in Healthy Chinese Subjects	4
Bioequivalence and Pharmacokinetic Evaluation of 2 Pyrazinamide Formulations in Healthy Chinese Adults: A Single‐Dose, Open‐Label, Randomized‐Sequence, 2×2 Crossover Study	4
Pharmacokinetics and Bioequivalence of Fudosteine in Healthy Chinese Volunteers Under Fasting and Fed Conditions: A 4‐Way Replicate Crossover Study	4
Issue Information	4
Population Pharmacokinetic Analysis of Valsartan in Healthy Chinese Subjects	4
Bridging Efficacy of Tofacitinib Immediate‐Release to Extended‐Release Formulations for Treatment of Ulcerative Colitis: Application of a Model‐Informed Drug Development Approach	3
Results from a Phase 1 Study Assessing the Pharmacokinetics of the Aldosterone Synthase Inhibitor Baxdrostat in Participants with Varying Degrees of Renal Function	3
Population Pharmacokinetics of Tenofovir Alafenamide Fumarate and Its Metabolite Tenofovir in Healthy Chinese Volunteers	3
Pharmacokinetic and Bioequivalent Study of Potassium Chloride Sustained‐Release Tablet Under Different Dietary Conditions in Healthy Chinese Subjects	3
The Safety, Toleration, and Pharmacokinetics of Two Intravenous Voriconazole Formulations in Healthy Chinese Volunteers After Increasing Dose Administrations	3
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	3
Effect of Silymarin Treatment on Circulating Bilirubin and Cardiovascular Disease Risk Factors in Healthy Men: A Single‐Blind, Randomized Crossover Trial	3

Lack of Electrocardiographic Effects of Deucravacitinib in Healthy Subjects	3
Pharmacokinetics and Bioequivalence of Two Formulations of Rosuvastatin Following Single‐dose Administration in Healthy Chinese Subjects Under Fasted and Fed Conditions	3
Bioequivalence Study of Velpatasvir/Sofosbuvir Oral Coated Tablets in Healthy Volunteers Under Fasting Conditions	3
Lack of Pharmacokinetic Drug–Drug Interactions Between Bepirovirsen and Nucleos(t)ide Analogs	3
Effect of Pantoprazole on the Absorption of Hydroxychloroquinea A Randomized Drug‐Drug Interaction Trial in Healthy Adults	3
Comparative Pharmacokinetics, Safety, and Immunogenicity Study of the Prefilled Syringe and Lyophilized Formulation of a Recombinant Human Tumor Necrosis Factor‐α Receptor II:lgG Fc Fusion Protein in	3
Pharmacokinetics of Asciminib When Taken With Imatinib or With Food	3
Issue Information	3
Pharmacokinetics and Safety Study of HN0037, a Novel Anti‐Human Herpes Simplex Virus Inhibitor, in Healthy Volunteers	3
Evaluation of Acarbose Bioequivalence in Healthy Chinese Populations Using Novel Pharmacodynamic End Points	3
Issue Information	3
Issue Information	3
Safety, Tolerability, and Pharmacokinetic Profile of the Low‐Impact Ampakine CX1739 in Young Healthy Volunteers	3
Safety, Tolerability, and Pharmacokinetic Evaluation of Single and Multiple Doses of the Dipeptidyl Peptidase 1 Inhibitor Brensocatib in Healthy Japanese and White Adults	3
Evaluation of Pharmacokinetics and Safety With Bioequivalence of Voriconazole Injection of 2 Formulations in Chinese Healthy Volunteers: Bioequivalence Study	3
Pharmacokinetics and Bioequivalence Evaluation of Trazodone Hydrochloride Sustained‐Release Tablets in Healthy Chinese Volunteers	3
Pharmacokinetics of Depemokimab Delivered by Safety Syringe Device or Autoinjector in Healthy Adults: A Phase 1, Single‐Dose Study	3
	3
Effect of Varying Degrees of Hepatic Impairment on the Pharmacokinetics of Omecamtiv Mecarbil	3
The Bioequivalence of Abexinostat (CRA‐024781) Tosylate Tablets (20 mg) in Chinese Healthy Subjects Under Fasting Conditions	3
A Randomized, Cross‐Over Study Investigating the Comparability of Somatrogon‐ghla in 2 Different Drug Product Presentations	3
Effect of a High‐Fat Meal on the Pharmacokinetics of an Immediate Release Atogepant Tablet	3
Effect of a High‐Fat Meal on Single‐Dose Rencofilstat (CRV431) Oral Bioavailability in Healthy Human Subjects	3
Pharmacokinetics and Bioequivalence of 2 Oral Formulations of Vildagliptin in Healthy Chinese Subjects	3
Safety, Pharmacokinetics, and Pharmacodynamics of the ADAMTS‐5 Inhibitor GLPG1972/S201086 in Healthy Volunteers and Participants With Osteoarthritis of the Knee or Hip	3
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A Phase 1 Thorough QT/QTc Study of Therapeutic and Supratherapeutic Doses of Belumosudil in Healthy Subjects	3
Effect of High‐Fat Diets on the Pharmacokinetics of Bedaquiline Fumarate Tablet: A Trial in Healthy Chinese Participants	3
Population Pharmacokinetics of Butylphthalide Injection in Elderly Chinese Patients With Ischemic Stroke	3
Safety, Pharmacokinetics, and Pharmacodynamics of Etavopivat (FT‐4202), an Allosteric Activator of Pyruvate Kinase‐R, in Healthy Adults: A Randomized, Placebo‐Controlled, Double‐Blind, First‐in‐Human	3
A Phase 1 Clinical Study Evaluating the Effects of Cenobamate on the QT Interval	3
Pharmacokinetics and Bioequivalence of Single‐Oral‐Dose Linagliptin: A Randomized, 2‐Period Crossover Trial in Chinese Healthy Subjects Under Fasting and Fed Conditions	3
Pharmacokinetics and Pharmacodynamics of Repository Corticotropin Injection Compared With Synthetic ACTH_1‐24 Depot and Methylprednisolone in Healthy Subjects	3
Should Estimated Glomerular Filtration Rate Be Adjusted for Race?	3
Issue Information	3
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Issue Information	2
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Bioequivalence Study of Atenolol Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions	2
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Comparative Pharmacokinetics and Bioequivalence of 2 Formulations of Bosentan Dispersible Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions	2
Drug‐Drug Interactions With the Hepatitis B Virus Capsid Assembly Modulator JNJ‐56136379 (Bersacapavir)	2
Relative Bioavailability and Food Effect of GSK3640254 Tablet and Capsule Formulations in Healthy Participants	2
Lack of an Effect of Supratherapeutic Dose of Venlafaxine on Cardiac Repolarization in Healthy Subjects	2
Issue Information	2
Pharmacokinetic and Bioequivalence Studies of 2 Metformin Glibenclamide Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions	2
Bioequivalence and Pharmacokinetic Profiles of 2 Trimetazidine Modified‐release Tablets Under Fasting and Fed Conditions in Chinese Healthy Subjects	2
Pharmacokinetic Similarity of ABP 654, an Ustekinumab Biosimilar Candidate: Results from a Randomized, Double‐blind Study in Healthy Subjects	2
Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects	2
Evaluation of Bioequivalence for Avapritinib Tablets in Chinese Participants Under Fasting Conditions Using a Reference‐Scaled Average Bioequivalence Method	2
Single‐Dose Pharmacokinetics and Tolerability of the Oral Epidermal Growth Factor Receptor Inhibitor Mobocertinib (TAK‐788) in Healthy Volunteers: Low‐Fat Meal Effect and Relative Bioavailability of 2	2
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Population Pharmacokinetics Analysis of Pemigatinib in Patients With Advanced Malignancies	2
PKPD Modeling and Simulations to Support Biosimilar Development of Biphasic Insulin Aspart 30	2
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Pharmacokinetic and Bioequivalence Study of Eldecalcitol Soft Capsules in Healthy Chinese Subjects	2
Pharmacokinetics and Safety of Letermovir and Midazolam Coadministration in Healthy Subjects	2
Pharmacokinetics of Nifedipine‐Sustained Release Tablets in Healthy Subjects After a Single Oral Administration: Bioequivalence Analysis and Food Effects	2
A Phase 1, Randomized, Double‐Blind, Placebo‐Controlled, Single Ascending Dose Trial of AWZ1066S, an Anti‐Wolbachia Candidate Macrofilaricide	2
Comparative Bioavailability of a Novel Fixed‐dose Combination Etoricoxib and Tramadol	2
Bioequivalence and Tolerability of 2 Lurasidone Formulations: A Randomized, Single‐Dose, 2‐Period, Crossover Study in Healthy Chinese Subjects Under Fasting and Fed Conditions	2
Bioequivalence of Two 6‐Mercaptopurine Tablet Formulations in Healthy Fasting Chinese Volunteers	2
Clinical Pharmacokinetics of Daprodustat: Results of an Absorption, Distribution, and Excretion Study With Intravenous Microtracer and Concomitant Oral Doses for Bioavailability Determination	2
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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Oral NLRP3 Inflammasome Inhibitor ZYIL1: First‐in‐Human Phase 1 Studies (Single Ascending Dose and Multiple Ascending Dose)	2
Apixaban Pharmacokinetics and Bioequivalence of Two Tablet Formulations: A Randomized, Open‐Label, Crossover Study, Fasting Condition in Healthy Indonesian Volunteers	2
Changes in Urinary Uric Acid Concentration after Dotinurad Administration to Patients with Hyperuricemia: A Post Hoc Analysis of Two Clinical Trials in Japan	2
Bioequivalence Study of Bedaquiline Fumarate Tablets in Healthy Chinese Subjects	2
Four‐Way Crossover Phase 1 Thorough QT Study to Assess Cardiac Safety of Domperidone and Consideration for Design and Conduct of QT/QTc Study in China	2
Bioequivalence of 200 mg Amisulpride Tablets in Healthy Chinese Volunteers under Fasting and Fed Conditions	2
Blood Pressure Recovery After Dobutamine Antagonism: Partial With Landiolol, None With Esmolol	2
Pharmacokinetics and Safety Evaluation of Maribavir in Healthy Japanese and Matched White Participants: A Phase 1, Open‐Label Study	2
Pilocarpine‐Induced Effects on Salivary Secretion as a Pharmacological Biomarker for Cholinergic Parasympathetic Activation	2
Issue Information	2
Exposure‐Response Analysis to Assess the Concentration‐QTc Relationship of Iberdomide	2
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Safety and Pharmacokinetics of Quizartinib Combination Therapy With Standard Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia: Results from Two Phase 1	2
Pharmacokinetics and Safety of Single and Multiple Daily Dosing of 75‐mg Rimegepant Orally Disintegrating Tablets in Healthy Chinese Adults: A Randomized Placebo‐Controlled Trial	2
Pharmacokinetic Evaluation of the CYP3A4 and CYP2D6 Drug‐Drug Interaction and CYP3A4 Induction Potential of Omecamtiv Mecarbil: Two Open‐Label Studies in Healthy Subjects	2
Phase 1 Clinical Results for NP10679, a pH‐sensitive GluN2B‐selective N‐methyl‐d‐aspartate Receptor Inhibitor	2
Issue Information	2
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 Subje	2
Effect of Food on the Pharmacokinetics of Limertinib (ASK120067) and its Main Metabolite in Healthy Chinese Volunteers	2
Bioequivalence and Safety Assessment of 2 Formulations of Low‐Dose Metformin Hydrochloride under Fasting Conditions in Healthy Chinese Participants: A Randomized Phase 1 Clinical Trial	2
Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Abacavir/Dolutegravir/Lamivudine Combination Tablets in Healthy Japanese Study Participants	2
Evaluation of Potential Food Effects and Drug Interactions With Lansoprazole in Healthy Adult Volunteers Receiving Futibatinib	2
Population Pharmacokinetics and Exposure‐Response Relationship of Zimberelimab in Chinese Patients with Advanced Tumors	2
Evaluation of the Cytochrome P450 3A and P‐glycoprotein Drug‐Drug Interaction Potential of Futibatinib	2
Absorption, Metabolism, and Excretion of [¹⁴C]‐Labeled Anaprazole: A New Proton Pump Inhibitor, After a Single Oral Administration in Healthy Chinese Male Subjects	2
Pharmacokinetics of Enarodustat in Non‐Japanese and Japanese Healthy Subjects and in Patients With End‐Stage Renal Disease on Hemodialysis	1
New Ustekinumab Biosimilar Candidate FYB202: Pharmacokinetic Equivalence Demonstrated in a Randomized, Double‐Blind, Parallel‐Group, Single‐Dose Trial in Healthy Subjects	1
First‐in‐Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of Pirepemat, a Cortical Enhancer, in Healthy Volunteers	1
Effect of a High‐Fat Diet on the Pharmacokinetics and Safety of Rivaroxaban in Healthy Chinese Subjects	1
Bioequivalence and Relative Bioavailability Studies to Assess a New Acalabrutinib Formulation That Enables Coadministration With Proton‐Pump Inhibitors	1