Clinical Pharmacology in Drug Development

Article	Citations
Issue Information	74
Pharmacokinetics and Safety of Linezolid Tablets of 2 Different Manufacturers in Healthy Chinese Subjects in Fasting and Fed States	31
Physiologically Based Pharmacokinetic Modeling to Evaluate Drug‐Drug Interactions of Tacrolimus With Ritonavir, a CYP3A Irreversible Inhibitor: Applications for Dosing Optimization in Transplant Patie	28
Pharmacokinetic and Bioequivalence Evaluation of Ulipristal Acetate in Healthy Chinese Subjects in the Fasting and Postprandial Conditions	23
Pharmacokinetics and Bioequivalence of the Lubiprostone Capsule in Healthy Chinese Subjects	23
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	20
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 Volunteers	19
Dual Therapy Triumph: Yuquan Capsules and Metformin in Combating Type 2 Diabetes Mellitus Disorders	19
Impact of Sampling Window Variability on Pharmacokinetic Parameters Estimated by Non‐Compartmental Analysis: Case Studies of Various Types of Drugs	19
Phase 1 Mass Balance Study of Pizuglanstat: An Investigational Hematopoietic Prostaglandin D Synthase Inhibitor	19
Bioequivalence Assessment of Two Dapoxetine Hydrochloride Formulations in Healthy Chinese Males Under Fasted and Fed Conditions	17
Pharmacokinetics, Safety, and Bioequivalence of 2 Lopinavir/Ritonavir (200/50 mg) Tablets in Healthy Chinese Volunteers: Effect of Food on Absorption	16
Pharmacokinetics of Nitazoxanide Dry Suspensions After Single Oral Doses in Healthy Subjects: Food Effects Evaluation and Bioequivalence Study	16
Comparative bioavailability of a novel fixed‐dose combination of ticagrelor and acetylsalicylic acid	15
A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of TPN171 (a PDE5 Inhibitor) in Adults with Renal Impairment	15
A Drug‐Drug Interaction Study to Evaluate the Impact of Rimegepant on OCT2‐ and MATE1‐Mediated Transport of Metformin in Healthy Participants	15
Taste Profile and Relative Bioavailability of Tovorafenib Powder for Oral Suspension and Food Effect of the Tovorafenib Tablet 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	15
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A Comparative Analysis of the Pharmacodynamic and Pharmacokinetic Properties of 2 Controlled‐Release Formulations Versus a Marketed Orlistat Product	14
A Bioequivalence Study With Pharmacokinetic Endpoints for Azithromycin Eye Drops	14
Pharmacokinetics, Tolerability, and Safety of Glecaprevir/Pibrentasvir Co‐formulated Bilayer Tablet Following Repeated Administration in Healthy Chinese Adults	14
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Pharmacokinetics, Safety, and Tolerability of Cedirogant in Healthy Japanese and Chinese Adults	13
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Phase 1 Evaluation of the Bioequivalence and Drug‐Drug Interaction Potential of a Novel Fixed‐Dose Combination of Ezetimibe, Atorvastatin, and Amlodipine	13
Pharmacokinetic and Safety Comparison of Fixed‐Dose Combination of Cilostazol/Rosuvastatin (200 + 20 mg) Versus Concurrent Administration of the Separate Components in Healthy Adults	13
Combined Immediate‐Release and Extended‐Release Formulation of Sodium Valproate Provides Stable Plasma Levels for Inhibition of Histone Deacetylation	13
Effect of Renal and Hepatic Impairment on the Pharmacokinetics of Pritelivir and Its Metabolites	13
Strategies to Manage Dosing Deviations and Interruptions of Cabotegravir Long‐Acting Intramuscular Injections	12
Safety, Tolerability, and Pharmacokinetics of Donanemab in Healthy Chinese Participants: A Phase 1, Randomized, Double‐Blind, Placebo‐Controlled Study	11
An Open‐Label Study to Evaluate the Effect of Eluxadoline on the Single‐Dose Pharmacokinetics of Midazolam in Healthy Participants	11
ACCP Abstract Booklet	11
Pharmacokinetics, Safety, and Tolerability of Brivaracetam in Healthy Elderly Participants	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	10
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	10
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Neonatal Fc Receptor Inhibitor Rozanolixizumab: An Ethnic Sensitivity Study in Healthy Japanese, Chinese, and White Participants	10
Thorough QT Study on the Effect of Therapeutic and Supratherapeutic Dosing of Givinostat in Healthy Volunteers	10
Beyond the “Undruggable”: What Pancreatic Cancer Teaches Us About the Next Evolution of Clinical Pharmacology	9
Impact of a High‐Fat Meal on the Pharmacokinetics of Sotorasib, a KRAS G12C Inhibitor	9
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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	9
Evaluation of Food Effect on the Pharmacokinetics of Velufenacin, a New Muscarinic Receptor Antagonist, in Healthy Subjects	9
A Food‐Effect Study to Evaluate the Oral Bioavailability of Desidustat	9
The Triple‐Agonist Revolution: Retatrutide and the Paradigm Shift in Multi‐Hormonal Pharmacotherapy for Obesity and Cardiometabolic Comorbidities	9
Issue Information	9
Current Status of Weekly Insulin Analogs and Their Pharmacokinetic/Pharmacodynamic Evaluation by the Euglycemic Clamp Technique	8
Single‐Dose Pharmacokinetic Assessment of TNX‐102 SL (Cyclobenzaprine HCl Sublingual Tablets): Results From Randomized, Open‐Label Studies in Healthy Volunteers	8
Three‐Period Bioequivalence Study of Sodium Levofolinate Injection With Calcium Levofolinate for Injection and Sodium Folinate for Injection in Healthy Chinese Subjects	8
Issue Information	8
Extrapolation of Midazolam Disposition in Neonates Using Physiological‐Based Pharmacokinetic/Pharmacodynamic Modeling	7
Osimertinib Efficacy and Safety in Treating Epidermal Growth Factor Receptor Mutation‐Positive Advanced Non–Small‐Cell Lung Cancer: A Meta‐Analysis	7
Pharmacokinetic Evaluation of the CYP3A4 and CYP2C9 Drug‐Drug Interaction of Avacopan in 2 Open‐Label Studies in Healthy Participants	7
Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Recombinant Neorudin, a New Anticoagulant Drug in Patients With Acute Coronary Syndrome	7
Pharmacokinetics, Bioequivalence, and Safety of Levothyroxine Sodium Tablets in Healthy Chinese Subjects	7
Bioequivalence Study of Miglitol Orally Disintegrating Tablets in Healthy Chinese Volunteers Under Fasting Condition Based on Pharmacodynamic and Pharmacokinetic Parameters	7
Population Pharmacokinetic and Pharmacodynamic Modeling of Romiplostim Biosimilar GP40141 and Reference Product in Healthy Volunteers to Evaluate Biosimilarity	7
A Drug–Drug Interaction Study of Mobocertinib and Midazolam, a Cytochrome P450 3A Substrate, in Patients With Advanced Non–Small Cell Lung Cancer	7
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Effects of Omeprazole and Verapamil on the Pharmacokinetics, Safety, and Tolerability of Mavacamten: Two Drug–Drug Interaction Studies in Healthy Participants	7
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	7
Effect of Erdafitinib on the Pharmacokinetics of Midazolam and Metformin in Patients With Advanced Solid Tumors Harboring FGFR Gene Alterations	7
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A 2‐Part, Open‐Label, Phase 1 Bioequivalence and Food‐Effect Study of Ubrogepant in Healthy Adult Participants	7
Clinical Pharmacology of GP40321 (Insulin Glulisine Biosimilar): Pharmacokinetic and Pharmacodynamic Comparability in a Hyperinsulinemic‐Euglycemic Clamp Procedure	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
Issue Information	6
Safety and Pharmacokinetics of a Combined Antioxidant Therapy against Myocardial Reperfusion Injury: A Phase 1 Randomized Clinical Trial in Healthy Humans	6
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
Pharmacokinetics, Bioequivalence, and Safety of Diclofenac Sodium Sustained‐Release Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions	6
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	6
Relative Bioavailability Studies With Mitapivat: Formulation and Food Effect Assessments in Healthy Subjects	6
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LP‐001, a Novel Long‐Acting EPO‐Fc Fusion Protein: A Phase I Dose‐Escalation Study of Pharmacokinetics, Safety, and Tolerability in Healthy Chinese Subjects	6
Authorship	6
Evaluation of the Clinical Drug‐Drug Interaction Potential of Pritelivir on Transporters and CYP450 Enzymes Using a Cocktail Approach	6
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‐Grou	6
Safety, Tolerability, and Pharmacokinetics of Galcanezumab, an Anti‐CGRP Antibody, in Healthy Chinese Participants	6
Cardiovascular Evaluation of Etrasimod, a Selective Sphingosine 1‐phosphate Receptor Modulator, in Healthy Adults: Results of a Randomized, Thorough QT/QTc Study	6
The Work Behind the First Dose: How Early Clinical Studies Shape the Course of Drug Development	6
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Comparison of ABBV‐552 Safety and Pharmacokinetics in Healthy Asian and Western Adults	6
Pharmacokinetics and Safety of Vibegron 75 mg Administered as an Intact or Crushed Tablet in Healthy Adults	6
Impact of Sotorasib, a KRAS G12C Inhibitor, on the Pharmacokinetics and Therapeutic Window of Digoxin, a P‐Glycoprotein Substrate	6
Comparative Bioavailability of Two Daily Subcutaneous Doses Versus a Single Dose of Intramuscular and Vaginal Progesterone Formulations in Healthy Postmenopausal Females	6
Clinical Impact of Antipolyethylene Glycol (PEG) Antibody in Hematological Patients Administered PEGylated‐Granulocyte Colony‐Stimulating Factor	6
Pharmacokinetics, Bioequivalence, and Safety Evaluation of Two Voriconazole Tablets in Healthy Chinese Volunteers	6
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 Participants	6
Pharmacokinetics and Drug–Drug Interaction of Allisartan Isoproxil and Indapamide Sustained‐Release Formulation	6
Safety, Tolerability, and Pharmacokinetics of Mufemilast, a PDE4 Inhibitor, in Healthy Participants: A First‐in‐Human Phase 1 Study	6
From Reflection to Acceleration: Clinical Pharmacology’s 2025 Lessons and 2026 Opportunities	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
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
Effect of Multiple Doses of Sparsentan on the Single‐Dose Pharmacokinetics of Dapagliflozin: An Open‐Label Drug–Drug Interaction Study in Healthy Adults	5
Disposition and Absolute Bioavailability of Oral Imlunestrant in Healthy Women: A Phase 1, Open‐Label Study	5
Issue Information	5
Safety, Tolerability, and Pharmacokinetics of a Novel Oral Phosphodiesterase 4 Inhibitor, ME3183: First‐in‐Human Phase 1 Study	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
Antipyretic Effect of Dexibuprofen Versus Ibuprofen in Children With Fever Caused by Upper Respiratory Tract Infection	5
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2024 CPDD Abstract Booklet	5
Effect of Itraconazole or Rifampin on Zilurgisertib Pharmacokinetics When Administered Orally in Healthy Participants	5
Population Pharmacokinetics Modeling and Simulation of Deutenzalutamide, A Novel Androgen Receptor Antagonist, in Patients With Metastatic Castration‐Resistant Prostate Cancer	5
Issue Information	5
Absolute Bioavailability and Absorption, Distribution, Metabolism, and Excretion of [ 14 C]Xevinapant, a Potent, Oral, Small‐Molecule IAP Inhibitor	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
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Pharmacokinetics and Bioequivalence of Amlodipine Besylate Tablet in Healthy Chinese Volunteers Under Fasting and Fed Conditions	5
No Influence of Asundexian on Cardiac Repolarization	5
Disposition and Mass Balance of Etrasimod in Healthy Subjects and In Vitro Determination of the Enzymes Responsible for Its Oxidative Metabolism	5
Clinical Significance of IL‐4 and IL‐21 Concurrent Elevation in Predicting Disease Activity Score and Antihistamine Treatment Response in Chronic Spontaneous Urticaria	4
Optimization of Romiplostim Biosimilar Efficacy Trial Using In Silico Clinical Trial Approach for Patients With Immune Thrombocytopenia	4
First‐in‐Human Study of Merotocin, a Short‐Acting Peptidic Oxytocin Receptor Agonist for Lactation Support	4
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	4
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
Issue Information	4
Pharmacokinetics, Bioequivalence, and Safety Evaluation of 2 Formulations of 10‐mg Rivaroxaban Tablets: A 4‐Period Crossover Trial	4
Comparative Bioequivalence and Safety Evaluation of Ibuprofen/Phenylephrine Hydrochloride Fixed‐Dose Combination Tablets in Healthy Chinese Volunteers	4
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	4
Physiologically Based Pharmacokinetic Absorption Model for Pexidartinib to Evaluate the Impact of Meal Contents and Intake Timing on Drug Exposure	4
Safety, Pharmacokinetics, and Biomarkers of an Amorphous Solid Dispersion of Genistein, a Radioprotectant, in Healthy Volunteers	4
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Comparison of Two Manufacturing Processes of Daprodustat for Bioequivalence and Dissolution in Healthy Volunteers: A Randomized Crossover Study	4
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Issue Information	4
Comparative Bioequivalence Study of 2 Clevidipine Formulations in Healthy Chinese participants: A Single‐Dose, 2‐Period Crossover Trial	4
Bioequivalence of Pomalidomide Capsules in Fasting and Fed States in Healthy Male Volunteers: A Randomized, Open, Single‐Dose, Biperiodic, Double‐Crossover Study	4
Bioequivalence Study of Two Formulations of Mifepristone Tablets in Healthy Chinese Subjects Under Fasting Conditions	4
A Human Mass Balance and Metabolism Study of [ 14 C]‐Ubrogepant in Healthy Male Adults	4
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 Individuals	3
Pharmacokinetic and Bioequivalence Evaluation of Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate, and Aspirin Tablets in Healthy Chinese Subjects in the Fasting and Postprandial Conditions	3
Pharmacological Parameters and Pharmacokinetic Variability Derived from Bioequivalence Trials in a Mexican Population	3
Population Pharmacokinetics of Tenofovir Alafenamide Fumarate and Its Metabolite Tenofovir in Healthy Chinese Volunteers	3
Effects of Cedirogant on the Pharmacokinetics of Sensitive Cytochrome P450 Probe Substrates	3
Issue Information	3
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 Fa	3
A Phase 1, Open‐Label, Single‐Dose Study of the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib, an FGFR Inhibitor	3
Effect of Food on the Pharmacokinetics and Pharmacodynamics of a Novel Dual Delayed‐Release Formulation of Esomeprazole in Healthy Subjects	3
Population Pharmacokinetics of Butylphthalide Injection in Elderly Chinese Patients With Ischemic Stroke	3
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	3
Pharmacokinetics and Food Effect Between a 100‐mg Sustained‐Release Tablet and a 50‐mg Immediate‐Release Tablet of Vildagliptin in Healthy Subjects	3
Pharmacokinetics and Bioequivalence of a Generic Ticagrelor 90‐mg Formulation Versus the Innovator Product in Healthy White Subjects Under Fasting Conditions	3
Bioequivalence of Meloxicam Nanocrystal Injection in Healthy Chinese Volunteers	3
Population Pharmacokinetic Model of N‐Acetylcysteine During Periods of Recurrent Hypoglycemia in Healthy Volunteers	3
Effect of Cytochrome P450 3A Inhibition and Induction by Itraconazole and Rifampin on Tazemetostat Pharmacokinetics in Patients With Advanced Malignancies	3
Correction to Rimegepant 75 mg in Subjects With Hepatic Impairment: Results of a Phase 1,Open‐Label, Single‐Dose, Parallel‐Group Study	3
First‐In‐Human Study to Assess the Pharmacokinetics and Safety of DS‐6016a After Single Subcutaneous Injection in Healthy Japanese Adults	3
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 Trial	3
A Single‐dose, Two‐Period Crossover Bioequivalence Study Comparing Two Liraglutide Formulations in Healthy Chinese Subjects	3
Safety and Pharmacokinetics of Single‐Dose Mirikizumab in Chinese Healthy Participants: Results From a Phase 1 Study	3
Bioequivalence Study of 2 Formulations of Fluticasone Nasal Spray in Healthy Chinese Volunteers	3
Issue Information	3
Evaluation of Acarbose Bioequivalence in Healthy Chinese Populations Using Novel Pharmacodynamic End Points	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
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	3
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Comparability of Elezanumab Safety, Tolerability, and Pharmacokinetics in Healthy Japanese, Chinese, and White Participants	3
Pharmacokinetics, Bioequivalence, and Safety of Esomeprazole Magnesium Enteric‐Coated Capsules in Healthy Chinese Subjects	3
Bioequivalence of Elagolix/Estradiol/Norethindrone Acetate Fixed‐Dose Combination Product: Phase 1 Results in Healthy Pre‐ and Postmenopausal Women	3
Effect of a High‐Fat Meal on the Pharmacokinetics of an Immediate Release Atogepant Tablet	3
Evaluation of clinical cardiac safety of zilurgisertib, an activin receptor‐like kinase‐2 (ALK2) inhibitor, in healthy participants	3
Population Pharmacokinetic Analysis of Valsartan in Healthy Chinese Subjects	3
Pharmacokinetics and Safety Evaluation of a New Generic Sitafloxacin: A Phase I Bioequivalence Study in Healthy Chinese Participants	3
Pharmacokinetic and Bioequivalence Evaluation of Single‐Tablet and Separate‐Tablet Regimens for Ainuovirine, Lamivudine, and Tenofovir Disoproxil Fumarate in Chinese Healthy Subjects	3
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	3
Pharmacokinetics and Bioequivalence of Vardenafil Hydrochloride in Healthy Chinese Volunteers	3
Pharmacokinetics and Bioequivalence Evaluation of Trazodone Hydrochloride Sustained‐Release Tablets in Healthy Chinese Volunteers	3
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Disposition and Absolute Bioavailability of Orally Administered Orforglipron in Healthy Participants	3
Absolute and Relative Bioavailability of Oral Solid Dosage Formulations of Deucravacitinib in Humans	3
Pharmacokinetics and bioequivalence of two N‐acetylcysteine tablets in healthy Chinese volunteers under fasting and fed conditions	3