Clinical Pharmacology in Drug Development

Article	Citations
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	60
Issue Information	26
Pharmacokinetics and Safety of Linezolid Tablets of 2 Different Manufacturers in Healthy Chinese Subjects in Fasting and Fed States	25
Phase 1 Mass Balance Study of Pizuglanstat: An Investigational Hematopoietic Prostaglandin D Synthase Inhibitor	21
Taste Profile and Relative Bioavailability of Tovorafenib Powder for Oral Suspension and Food Effect of the Tovorafenib Tablet in Healthy Participants	20
Bioequivalence of Esaxerenone Conventional Tablet and Orally Disintegrating Tablet: Two Single‐Dose Crossover Studies in Healthy Japanese Men	20
Pharmacokinetics of Nitazoxanide Dry Suspensions After Single Oral Doses in Healthy Subjects: Food Effects Evaluation and Bioequivalence Study	19
Physiologically Based Pharmacokinetic Modeling to Evaluate Drug‐Drug Interactions of Tacrolimus With Ritonavir, a CYP3A Irreversible Inhibitor: Applications for Dosing Optimization in Transplant Patie	17
Bioequivalence Assessment of Two Dapoxetine Hydrochloride Formulations in Healthy Chinese Males Under Fasted and Fed Conditions	17
Pharmacokinetic and Bioequivalence Evaluation of Ulipristal Acetate in Healthy Chinese Subjects in the Fasting and Postprandial Conditions	17
Dual Therapy Triumph: Yuquan Capsules and Metformin in Combating Type 2 Diabetes Mellitus Disorders	16
A Comparative Analysis of the Pharmacodynamic and Pharmacokinetic Properties of 2 Controlled‐Release Formulations Versus a Marketed Orlistat Product	16
Target‐Mediated Modeling of Alirocumab in Adolescents and Children ≥8 to <12 Years of Age Using Phase II and III Data	15
A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of TPN171 (a PDE5 Inhibitor) in Adults with Renal Impairment	14
Pharmacokinetics and Bioequivalence of the Lubiprostone Capsule in Healthy Chinese Subjects	13
	13
	13
Pharmacokinetics, Safety, and Bioequivalence of 2 Lopinavir/Ritonavir (200/50 mg) Tablets in Healthy Chinese Volunteers: Effect of Food on Absorption	13
A Drug‐Drug Interaction Study to Evaluate the Impact of Rimegepant on OCT2‐ and MATE1‐Mediated Transport of Metformin in Healthy Participants	13
	13
Pharmacokinetics, Tolerability, and Safety of Glecaprevir/Pibrentasvir Co‐formulated Bilayer Tablet Following Repeated Administration in Healthy Chinese Adults	13
Evaluation of Food Effect on the Pharmacokinetics of Velufenacin, a New Muscarinic Receptor Antagonist, in Healthy Subjects	13
A Bioequivalence Study With Pharmacokinetic Endpoints for Azithromycin Eye Drops	13
Effect of Renal and Hepatic Impairment on the Pharmacokinetics of Pritelivir and Its Metabolites	12
Pharmacokinetics and Safety of the Nucleoside Analog Antiviral Drug Galidesivir Administered to Healthy Adult Subjects	12

Phase 1 Evaluation of the Bioequivalence and Drug‐Drug Interaction Potential of a Novel Fixed‐Dose Combination of Ezetimibe, Atorvastatin, and Amlodipine	12
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	12
Pharmacokinetic and Safety Comparison of Fixed‐Dose Combination of Cilostazol/Rosuvastatin (200 + 20 mg) Versus Concurrent Administration of the Separate Components in Healthy Adults	12
Effect of Carbamazepine on the Pharmacokinetics of Erdafitinib in Healthy Participants	11
An Open‐Label Study to Evaluate the Effect of Eluxadoline on the Single‐Dose Pharmacokinetics of Midazolam in Healthy Participants	11
Effect of Phosphate Binders and a Dietary Iron Supplement on the Pharmacokinetics of a Single Dose of Vadadustat in Healthy Adults	11
Combined Immediate‐Release and Extended‐Release Formulation of Sodium Valproate Provides Stable Plasma Levels for Inhibition of Histone Deacetylation	11
Strategies to Manage Dosing Deviations and Interruptions of Cabotegravir Long‐Acting Intramuscular Injections	11
Evaluation of Deutetrabenazine's Potential to Delay Cardiac Repolarization Using Concentration‐QTc Analysis	11
Pharmacokinetics, Safety, and Tolerability of Cedirogant in Healthy Japanese and Chinese Adults	11
Safety, Tolerability, and Pharmacokinetics of Donanemab in Healthy Chinese Participants: A Phase 1, Randomized, Double‐Blind, Placebo‐Controlled Study	11
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Neonatal Fc Receptor Inhibitor Rozanolixizumab: An Ethnic Sensitivity Study in Healthy Japanese, Chinese, and White Participants	11
Impact of a High‐Fat Meal on the Pharmacokinetics of Sotorasib, a KRAS G12C Inhibitor	10
Pharmacokinetics, Safety, and Tolerability of Brivaracetam in Healthy Elderly 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
ACCP Abstract Booklet	10
Current Status of Weekly Insulin Analogs and Their Pharmacokinetic/Pharmacodynamic Evaluation by the Euglycemic Clamp Technique	9
Effect of Erdafitinib on the Pharmacokinetics of Midazolam and Metformin in Patients With Advanced Solid Tumors Harboring FGFR Gene Alterations	9
Population Pharmacokinetic and Pharmacodynamic Modeling of Romiplostim Biosimilar GP40141 and Reference Product in Healthy Volunteers to Evaluate Biosimilarity	9
Pharmacokinetic Evaluation of the CYP3A4 and CYP2C9 Drug‐Drug Interaction of Avacopan in 2 Open‐Label Studies in Healthy Participants	9
	9
Extrapolation of Midazolam Disposition in Neonates Using Physiological‐Based Pharmacokinetic/Pharmacodynamic Modeling	9
Issue Information	9
Issue Information	9
Three‐Period Bioequivalence Study of Sodium Levofolinate Injection With Calcium Levofolinate for Injection and Sodium Folinate for Injection in Healthy Chinese Subjects	9
Bioequivalence Study of Miglitol Orally Disintegrating Tablets in Healthy Chinese Volunteers Under Fasting Condition Based on Pharmacodynamic and Pharmacokinetic Parameters	9
Osimertinib Efficacy and Safety in Treating Epidermal Growth Factor Receptor Mutation‐Positive Advanced Non–Small‐Cell Lung Cancer: A Meta‐Analysis	9
A Food‐Effect Study to Evaluate the Oral Bioavailability of Desidustat	9
	9
Pharmacokinetics of Amoxicillin and Clavulanate Potassium for Suspension (200 mg/28.5 mg) in Healthy Subjects: Sample Add Stabilizer Study and Food Effects	9
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	9
Effects of Omeprazole and Verapamil on the Pharmacokinetics, Safety, and Tolerability of Mavacamten: Two Drug–Drug Interaction Studies in Healthy Participants	9
Bioequivalence and Food Effect Assessment of Eltrombopag Olamine Tablets in Healthy Chinese Subjects: An Open, Randomized, Single‐Dose, and Two‐Period Crossover Study	8
Pharmacokinetics of Esomeprazole Magnesium After Single Oral Doses in Healthy Subjects: Bioequivalence Study and Food Effects	8
List of Reviewers 2021	8
	8
A Drug–Drug Interaction Study of Mobocertinib and Midazolam, a Cytochrome P450 3A Substrate, in Patients With Advanced Non–Small Cell Lung Cancer	8
Comparative Bioavailability of Two Daily Subcutaneous Doses Versus a Single Dose of Intramuscular and Vaginal Progesterone Formulations in Healthy Postmenopausal Females	8
Pharmacokinetics, Bioequivalence, and Safety of Levothyroxine Sodium Tablets in Healthy Chinese Subjects	7
Pharmacokinetics and Bioequivalence Studies of Roxatidine Acetate Hydrochloride Sustained‐Release Capsule in Healthy Chinese Subjects	7
Absolute Bioavailability, Mass Balance, and Metabolic Profiling Assessment of [14C]‐Belumosudil in Healthy Men: A Phase 1, Open‐Label, 2‐Part Study	7
Evaluation of the Clinical Drug‐Drug Interaction Potential of Pritelivir on Transporters and CYP450 Enzymes Using a Cocktail Approach	7
Authorship	7
Impact of Sotorasib, a KRAS G12C Inhibitor, on the Pharmacokinetics and Therapeutic Window of Digoxin, a P‐Glycoprotein Substrate	7
Relative Bioavailability Studies With Mitapivat: Formulation and Food Effect Assessments in Healthy Subjects	7
Clinical Impact of Antipolyethylene Glycol (PEG) Antibody in Hematological Patients Administered PEGylated‐Granulocyte Colony‐Stimulating Factor	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	7
A 2‐Part, Open‐Label, Phase 1 Bioequivalence and Food‐Effect Study of Ubrogepant in Healthy Adult Participants	7
Population Pharmacokinetic Modeling and Exposure‐Response Analysis for Aripiprazole Once Monthly in Subjects With Schizophrenia	7
Phase 1 Studies to Evaluate the Food Effect and Relative Bioavailability of Tablet and Capsule Formulations of Belumosudil in Healthy Adult Subjects	7

	7
Population Pharmacokinetics of Tralokinumab in Adult Subjects With Moderate to Severe Atopic Dermatitis	6
Pharmacokinetics and Drug–Drug Interaction of Allisartan Isoproxil and Indapamide Sustained‐Release Formulation	6
Disposition and Absolute Bioavailability of Oral Imlunestrant in Healthy Women: A Phase 1, Open‐Label Study	6
Issue Information	6
Pharmacokinetics and Bioequivalence of 2 Azithromycin Tablet Formulations: A Randomized, Open‐Label, 2‐Stage Crossover Study in Healthy Volunteers	6
Clinical Pharmacology of GP40321 (Insulin Glulisine Biosimilar): Pharmacokinetic and Pharmacodynamic Comparability in a Hyperinsulinemic‐Euglycemic Clamp Procedure	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
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
Safety, Tolerability, and Pharmacokinetics of Galcanezumab, an Anti‐CGRP Antibody, in Healthy Chinese Participants	6
No Influence of Asundexian on Cardiac Repolarization	6
Safety and Pharmacokinetics of a Combined Antioxidant Therapy against Myocardial Reperfusion Injury: A Phase 1 Randomized Clinical Trial in Healthy Humans	6
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	6
Cardiovascular Evaluation of Etrasimod, a Selective Sphingosine 1‐phosphate Receptor Modulator, in Healthy Adults: Results of a Randomized, Thorough QT/QTc Study	6
Population Pharmacokinetics Modeling and Simulation of Deutenzalutamide, A Novel Androgen Receptor Antagonist, in Patients With Metastatic Castration‐Resistant Prostate Cancer	6
Safety, Tolerability, and Pharmacokinetics of a Novel Oral Phosphodiesterase 4 Inhibitor, ME3183: First‐in‐Human Phase 1 Study	6
Pharmacokinetics and Safety of Vibegron 75 mg Administered as an Intact or Crushed Tablet in Healthy Adults	6
Dosing Recommendation Based on the Effects of Different Meal Types on Pexidartinib Pharmacokinetics in Healthy Subjects: Implementation of Model‐informed Drug Development Strategy	6
Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Recombinant Neorudin, a New Anticoagulant Drug in Patients With Acute Coronary Syndrome	6
Physiologically Based Pharmacokinetic Absorption Model for Pexidartinib to Evaluate the Impact of Meal Contents and Intake Timing on Drug Exposure	5
Issue Information	5
Safety, Pharmacokinetics, and Pharmacodynamics of Oral Insulin Administration in Healthy Subjects: A Randomized, Double‐Blind, Phase 1 Trial	5
	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
Bioequivalence Study of Two Formulations of Mifepristone Tablets in Healthy Chinese Subjects Under Fasting Conditions	5
Pharmacokinetics and Bioequivalence of Amlodipine Besylate Tablet in Healthy Chinese Volunteers Under Fasting and Fed Conditions	5
Comparative Bioequivalence Study of 2 Clevidipine Formulations in Healthy Chinese participants: A Single‐Dose, 2‐Period Crossover Trial	5
Comparative Bioequivalence and Safety Evaluation of Ibuprofen/Phenylephrine Hydrochloride Fixed‐Dose Combination Tablets in Healthy Chinese 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
Bioequivalence of Pomalidomide Capsules in Fasting and Fed States in Healthy Male Volunteers: A Randomized, Open, Single‐Dose, Biperiodic, Double‐Crossover Study	5
Effect of Itraconazole or Rifampin on Zilurgisertib Pharmacokinetics When Administered Orally in Healthy Participants	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
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	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
First‐in‐Human Study of Merotocin, a Short‐Acting Peptidic Oxytocin Receptor Agonist for Lactation Support	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
Antipyretic Effect of Dexibuprofen Versus Ibuprofen in Children With Fever Caused by Upper Respiratory Tract Infection	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
Issue Information	5
Optimization of Romiplostim Biosimilar Efficacy Trial Using In Silico Clinical Trial Approach for Patients With Immune Thrombocytopenia	5
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
Safety, Pharmacokinetics, and Biomarkers of an Amorphous Solid Dispersion of Genistein, a Radioprotectant, in Healthy Volunteers	5
	5
	5
Correction to Rimegepant 75 mg in Subjects With Hepatic Impairment: Results of a Phase 1,Open‐Label, Single‐Dose, Parallel‐Group Study	4
A Pharmacokinetic Bioequivalence Study Comparing Different‐Strength and ‐Size Capsules of Isavuconazonium Sulfate in Healthy Japanese Subjects	4
Pharmacokinetics of Icosapent Ethyl: An Open‐Label, Multiple Oral Dose, Parallel Design Study in Healthy Chinese Subjects	4
Comparison of Two Manufacturing Processes of Daprodustat for Bioequivalence and Dissolution in Healthy Volunteers: A Randomized Crossover Study	4
Pharmacokinetics and Bioequivalence of a Generic Ticagrelor 90‐mg Formulation Versus the Innovator Product in Healthy White Subjects Under Fasting Conditions	4
Issue Information	4
Population Pharmacokinetic Analysis of Valsartan in Healthy Chinese Subjects	4
Evaluation of clinical cardiac safety of zilurgisertib, an activin receptor‐like kinase‐2 (ALK2) inhibitor, in healthy participants	4
Pharmacological Parameters and Pharmacokinetic Variability Derived from Bioequivalence Trials in a Mexican Population	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	4
Pharmacokinetics and Bioequivalence of Vardenafil Hydrochloride in Healthy Chinese Volunteers	4
Comparability of Elezanumab Safety, Tolerability, and Pharmacokinetics in Healthy Japanese, Chinese, and White Participants	4
Safety and Pharmacokinetics of Single‐Dose Mirikizumab in Chinese Healthy Participants: Results From a Phase 1 Study	4
Population Pharmacokinetic Model of N‐Acetylcysteine During Periods of Recurrent Hypoglycemia in Healthy Volunteers	4
Pharmacokinetics and Bioequivalence of Fudosteine in Healthy Chinese Volunteers Under Fasting and Fed Conditions: A 4‐Way Replicate Crossover Study	4
Bioequivalence of Elagolix/Estradiol/Norethindrone Acetate Fixed‐Dose Combination Product: Phase 1 Results in Healthy Pre‐ and Postmenopausal Women	4
Bioequivalence Study of 2 Formulations of Fluticasone Nasal Spray in Healthy Chinese Volunteers	4
Pharmacokinetics, Safety, and Tolerability of Letermovir Following Single‐ and Multiple‐Dose Administration in Healthy Japanese Subjects	4
Absolute and Relative Bioavailability of Oral Solid Dosage Formulations of Deucravacitinib in Humans	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
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
A Single‐dose, Two‐Period Crossover Bioequivalence Study Comparing Two Liraglutide Formulations in Healthy Chinese Subjects	4
Pharmacokinetic and Bioequivalence Evaluation of Single‐Tablet and Separate‐Tablet Regimens for Ainuovirine, Lamivudine, and Tenofovir Disoproxil Fumarate in Chinese Healthy Subjects	4
Pharmacokinetics, Bioequivalence, and Safety Evaluation of 2 Formulations of 10‐mg Rivaroxaban Tablets: A 4‐Period Crossover Trial	4
Pharmacokinetics, Bioequivalence, and Safety Studies of Amlodipine Besylate in Healthy Subjects	4
Issue Information	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
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
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
Pharmacokinetics and Safety Evaluation of a New Generic Sitafloxacin: A Phase I Bioequivalence Study in Healthy Chinese Participants	4
A Phase 1 Clinical Study Evaluating the Effects of Cenobamate on the QT Interval	3
Issue Information	3
Effect of Food on the Pharmacokinetics and Pharmacodynamics of a Novel Dual Delayed‐Release Formulation of Esomeprazole in Healthy Subjects	3
Pharmacokinetics and bioequivalence of two N‐acetylcysteine tablets in healthy Chinese volunteers under fasting and fed conditions	3
	3

Effects of Unsuppressed Endogenous Insulin on Pharmacokinetics and/or Pharmacodynamics of Study Insulin in the Healthy: A Retrospective Study	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
Bioequivalence Study of Velpatasvir/Sofosbuvir Oral Coated Tablets in Healthy Volunteers Under Fasting Conditions	3
Issue Information	3
The Bioequivalence of Abexinostat (CRA‐024781) Tosylate Tablets (20 mg) in Chinese Healthy Subjects Under Fasting Conditions	3
Pharmacokinetic and Bioequivalence Evaluation of Two Sitagliptin Tablets With Different Salts in Healthy Subjects	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
Pharmacokinetics and Safety Study of HN0037, a Novel Anti‐Human Herpes Simplex Virus Inhibitor, 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
Bioequivalence of Meloxicam Nanocrystal Injection in Healthy Chinese Volunteers	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
Pharmacokinetics and Bioequivalence Evaluation of Trazodone Hydrochloride Sustained‐Release Tablets in Healthy Chinese Volunteers	3
Issue Information	3
Issue Information	3
Pharmacokinetics and Bioequivalence of Two Formulations of Rosuvastatin Following Single‐dose Administration in Healthy Chinese Subjects Under Fasted and Fed Conditions	3
Lack of Pharmacokinetic Drug–Drug Interactions Between Bepirovirsen and Nucleos(t)ide Analogs	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
Effect of a High‐Fat Meal on the Pharmacokinetics of an Immediate Release Atogepant Tablet	3
Pharmacokinetics, Bioequivalence, and Safety of Esomeprazole Magnesium Enteric‐Coated Capsules in Healthy Chinese Subjects	3
Population Pharmacokinetics of Tenofovir Alafenamide Fumarate and Its Metabolite Tenofovir in Healthy Chinese Volunteers	3
Disposition and Absolute Bioavailability of Orally Administered Orforglipron in Healthy Participants	3
Evaluation of Acarbose Bioequivalence in Healthy Chinese Populations Using Novel Pharmacodynamic End Points	3
Population Pharmacokinetics of Butylphthalide Injection in Elderly Chinese Patients With Ischemic Stroke	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 Bioequivalence of 2 Oral Formulations of Vildagliptin in Healthy Chinese Subjects	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
From Bench to Bedside and Beyond: Shaping the Future of Early‐Phase Clinical Pharmacology at CPDD	2
Drug‐Drug Interactions With the Hepatitis B Virus Capsid Assembly Modulator JNJ‐56136379 (Bersacapavir)	2
Safety, Tolerability, and Pharmacokinetics of the Long‐Acting SARS‐CoV‐2–Neutralizing Monoclonal Antibody Combination AZD7442 (Tixagevimab/Cilgavimab) in Healthy Chinese Adults	2
Bioequivalence of 200 mg Amisulpride Tablets in Healthy Chinese Volunteers under Fasting and Fed Conditions	2
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	2
	2
Pharmacokinetics and Bioequivalence of two Empagliflozin Tablet Formulations: Results From a Randomized, Open‐Label, Crossover Study in Fasting Healthy Volunteers	2
Bioequivalence Study of Atenolol Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions	2
Evaluation of Pharmacokinetics and Safety With Bioequivalence of Voriconazole Injection of 2 Formulations in Chinese Healthy Volunteers: Bioequivalence Study	2
Pharmacokinetic Similarity of ABP 654, an Ustekinumab Biosimilar Candidate: Results from a Randomized, Double‐blind Study in Healthy Subjects	2
Comparative Pharmacokinetics and Bioequivalence of Two Sodium Valproate Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions	2
Effect of High‐Fat Diets on the Pharmacokinetics of Bedaquiline Fumarate Tablet: A Trial in Healthy Chinese Participants	2
	2
	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
Pharmacokinetics of Nifedipine‐Sustained Release Tablets in Healthy Subjects After a Single Oral Administration: Bioequivalence Analysis and Food Effects	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
Comparative Pharmacokinetics and Bioequivalence of 2 Formulations of Bosentan Dispersible Tablets in Healthy Chinese Volunteers 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
Bioequivalence of Two 6‐Mercaptopurine Tablet Formulations in Healthy Fasting Chinese Volunteers	2
A Phase 1, Randomized, Double‐Blind, Placebo‐Controlled, Single Ascending Dose Trial of AWZ1066S, an Anti‐Wolbachia Candidate Macrofilaricide	2
Pharmacokinetics of Depemokimab Delivered by Safety Syringe Device or Autoinjector in Healthy Adults: A Phase 1, Single‐Dose Study	2
PKPD Modeling and Simulations to Support Biosimilar Development of Biphasic Insulin Aspart 30	2
Editorial: Early Phase Innovation—Adapting to the New Age of Accelerated Drug Approvals	2
Population Pharmacokinetics and Exposure‐Response Relationship of Zimberelimab in Chinese Patients with Advanced Tumors	2
Pharmacokinetic and Bioequivalent Study of Potassium Chloride Sustained‐Release Tablet Under Different Dietary Conditions in Healthy Chinese Subjects	2
Evaluation of Potential Effects of CYP3A Inhibition and CYP3A Induction on the Pharmacokinetics of Fruquintinib in Healthy Subjects	2
Bridging Efficacy of Tofacitinib Immediate‐Release to Extended‐Release Formulations for Treatment of Ulcerative Colitis: Application of a Model‐Informed Drug Development Approach	2
Concentration–QTc Modeling to Support Clinical Development of Fezolinetant	2
	2
Evaluation of the Cytochrome P450 3A and P‐glycoprotein Drug‐Drug Interaction Potential of Futibatinib	2
Apixaban Pharmacokinetics and Bioequivalence of Two Tablet Formulations: A Randomized, Open‐Label, Crossover Study, Fasting Condition in Healthy Indonesian Volunteers	2
Effect of Food on the Pharmacokinetics of Limertinib (ASK120067) and its Main Metabolite in Healthy Chinese Volunteers	2
	2
A Randomized, Cross‐Over Study Investigating the Comparability of Somatrogon‐ghla in 2 Different Drug Product Presentations	2
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
Relative Bioavailability and Food Effect of GSK3640254 Tablet and Capsule Formulations in Healthy Participants	2
Phase 1 Clinical Results for NP10679, a pH‐sensitive GluN2B‐selective N‐methyl‐d‐aspartate Receptor Inhibitor	2
Effect of a High‐Fat Meal on Single‐Dose Rencofilstat (CRV431) Oral Bioavailability in Healthy Human Subjects	2
Pharmacokinetic and Bioequivalence Study of Eldecalcitol Soft Capsules in Healthy Chinese Subjects	2
Lack of Electrocardiographic Effects of Deucravacitinib in Healthy Subjects	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
A Phase 1 Thorough QT/QTc Study of Therapeutic and Supratherapeutic Doses of Belumosudil in Healthy Subjects	2
Exposure‐Response Analysis to Assess the Concentration‐QTc Relationship of Iberdomide	2
	2
Comparative Bioavailability of a Novel Fixed‐dose Combination Etoricoxib and Tramadol	2
Computer‐Aided Algorithmic Approaches to Drug Development for Multi‐Mutant HIV‐1 Reverse Transcriptase	2
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
Safety, Tolerability, and Pharmacokinetic Profile of the Low‐Impact Ampakine CX1739 in Young Healthy Volunteers	2
The Safety, Toleration, and Pharmacokinetics of Two Intravenous Voriconazole Formulations in Healthy Chinese Volunteers After Increasing Dose Administrations	2
It Is Time to Re‐Think the Limit of Quantitation	2
Issue Information	2
Issue Information	2
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	2
	2
Issue Information	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
Comparison of the Pharmacokinetics of Three Budesonide Formulations in Healthy Chinese Subjects	2
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Bexicaserin in Healthy Participants: A First‐in‐Human Randomized, Double‐Blind, Placebo‐Controlled Single Ascending Dose Es	2
Correction to “Preclinical and Phase 1 Assessment of Antisense Oligonucleotide Bepirovirsenin Hepatitis B Virus–Transgenic Mice and Healthy Human Volunteers: Support for Clinical Dose Selection and Ev	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
A Population Pharmacokinetic Assessment of the Effect of Food on Selumetinib in Patients with Neurofibromatosis Type 1‐Related Plexiform Neurofibromas and Healthy Volunteers	1
Issue Information	1
New Ustekinumab Biosimilar Candidate FYB202: Pharmacokinetic Equivalence Demonstrated in a Randomized, Double‐Blind, Parallel‐Group, Single‐Dose Trial in Healthy Subjects	1
Effect of Meal Timings and Meal Content on the AUC0‐12h of Mycophenolic Acid: A Simulation Study	1
Similar Pharmacokinetics and Pharmacodynamics of Biosimilar SAR342434 Insulin Lispro and Japan‐Approved Humalog Insulin Lispro in Healthy Japanese Subjects	1
Safety, Pharmacokinetics, and Pharmacodynamics of Etrasimod: Single and Multiple Ascending Dose Studies in Healthy Adults	1
Review of the Chinese Landscape in Phase 1 Clinical Trials for Noncancer Innovative Drugs Over 2015 to 2020	1
CPDD 2024 Reviewer List	1