
自引率: 3.3%
被引量: 662
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国人发稿量: 1
期刊描述简介:
Clinical Pharmacology in Drug Development is an international, peer-reviewed, online publication focused on publishing high-quality clinical pharmacology studies in drug development which are primarily (but not exclusively) performed in early development phases in healthy subjects. Acceptance of a manuscript in Clinical Pharmacology in Drug Development will be determined by scientific rigor and technical soundness rather than perceived importance of the presented results. Thus, negative study results are explicitly not an obstacle for positive acceptance decisions. Keywords Clinical Pharmacology in Drug Development; Drug Development; Clinical Pharmacology and Therapeutics; Pharmacology & Pharmaceutical Medicine; Pharmaceutical and Medicinal Chemistry; Pharmacy; Clinical and Experimental Medical Research; Drug Discovery and Development; Toxicology; American College of Clinical Pharmacology; The Journal of Clinical Pharmacology; David J. Greenblatt; David Greenblatt; Abstracting and Indexing Information CAS: Chemical Abstracts Service (ACS) Embase (Elsevier) MEDLINE/PubMed (NLM) Science Citation Index Expanded (Clarivate Analytics) SCOPUS (Elsevier) Web of Science (Clarivate Analytics)
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Effect of Renal and Hepatic Impairment on the Pharmacokinetics of Pritelivir and Its Metabolites.
被引量:- 发表:1970
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Pharmacokinetics of Subcutaneous Itepekimab Injection With an Autoinjector Device and Prefilled Syringe in Healthy Participants.
被引量:- 发表:1970
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New Ustekinumab Biosimilar Candidate FYB202: Pharmacokinetic Equivalence Demonstrated in a Randomized, Double-Blind, Parallel-Group, Single-Dose Trial in Healthy Subjects.
被引量:- 发表:1970
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A Phase 1, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Bepirovirsen in Adults with Hepatic Impairment and Healthy Participants (B-Assured).
被引量:- 发表:1970
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Bioequivalence of Meloxicam Nanocrystal Injection in Healthy Chinese Volunteers.
This single-center, randomized, open, two-preparation, single-dose, two-period, self-crossover trial aimed to assess the bioequivalence and safety of the test (T) preparation compared to the reference (R) preparation following intravenous injection in healthy subjects under fasting conditions. Twenty-four healthy subjects were enrolled in the study and subjects were randomly divided into two groups at a 1:1 ratio and were administered once per period, with an 8-day washout period. During each period, serum drug concentrations were detected for pharmacokinetic analysis and adverse events were recorded for safety analysis. The 90% confidence intervals for the geometric mean ratios (T:R) of maximum serum concentration, area under the serum concentration-time curve from time zero to the last measurable concentration, and area under the serum concentration-time curve from time zero to infinite time fell within the predefined bioequivalence range of 80%-125%, indicating bioequivalence between the T and R preparation under fasting conditions. Additionally, four subjects (16.7%) experienced five instances of adverse events in the T group, while five subjects (21.7%) experienced five instances of adverse events in the R group. This trial indicated the potential bioequivalence between the T and R products under fasting conditions, based on pharmacokinetic and safety profile.
被引量:- 发表:1970