Clinical Pharmacology in Drug Development 
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(Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - July 1, 2023 Category: Drugs & Pharmacology Tags: Issue Information Source Type: research
Commentary on Improving the Efficiency of Clinical Pharmacology Studies
(Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - June 29, 2023 Category: Drugs & Pharmacology Authors: Michael J. Fossler Tags: Commentary Source Type: research
Safety, Pharmacokinetics, and Antifibrotic Activity of CC ‐90001 (BMS‐986360), a c‐Jun N‐Terminal Kinase Inhibitor, in Pulmonary Fibrosis
AbstractApproved treatments for idiopathic pulmonary fibrosis have tolerability concerns and limited efficacy. CC-90001, a c-Jun N-terminal kinase inhibitor, is under investigation as a therapy for fibrotic diseases. A Phase 1b safety, pharmacokinetics, and pharmacodynamics study of oral CC-90001 (100, 200, or 400 mg) administered once daily for 12 weeks was conducted in patients with pulmonary fibrosis (NCT02510937). Sixteen patients with a mean age of 68 years were studied. The most common treatment-emergent adverse events were nausea and headache; all events were of mild or moderate intensity. Pharmacoki netic profile...
Source: Clinical Pharmacology in Drug Development - June 28, 2023 Category: Drugs & Pharmacology Authors: Gerald Horan,
Ying Ye,
Mary Adams,
Anastasia Parton,
Dorota Cedzik,
Shaojun Tang,
Elizabeth A. Brown,
Liangang Liu,
Jim Nissel,
Leonidas N. Carayannopoulos,
Allison Gaudy,
Peter Schafer,
Maria Palmisano,
Francisco Ramirez ‐Valle Tags: Original Article Source Type: research
Improving the Efficiency of Clinical Pharmacology Studies
(Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - June 24, 2023 Category: Drugs & Pharmacology Authors: Thomas M. Polasek,
Virna Schuck Tags: Commentary Source Type: research
Bioequivalence of a Pediatric Fixed ‐Dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Compared With Coadministration of the Separate Agents in Healthy Adults: An Open‐Label, Randomized, Replicate Crossover Study
In conclusion, administration of D/C/F/TAF 675/150/200/10-mg FDC was bioequivalent to coadministration of the separate commercially available formula tions. (Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - June 20, 2023 Category: Drugs & Pharmacology Authors: Sandy Van Hemelryck,
Erika Van Landuyt,
Jay Ariyawansa,
Simon Vanveggel,
Martyn Palmer Tags: Original Article Source Type: research
Pharmacokinetics, Bioequivalence, and Safety of Esomeprazole Magnesium Enteric ‐Coated Capsules in Healthy Chinese Subjects
AbstractThis bioequivalence study is critically important for drug production. Recently, a local pharmaceutical company produced esomeprazole magnesium enteric-coated capsules, a major drug to help to eradicateHelicobacter pylori, but the bioequivalence is not well known. The present study aimed to evaluate the bioequivalence of the 2 esomeprazole magnesium enteric-coated capsules and their pharmacokinetics and safety in 3 biological equivalence trials: fasting, feeding, and mixing. The fasting and mixing trials used single-centered randomized, open-label, single-dose, 2-treatment, 2-period, and 2-sequence crossover design...
Source: Clinical Pharmacology in Drug Development - June 18, 2023 Category: Drugs & Pharmacology Authors: Juan Jin,
Cuiping Huang,
Changhai Zhu,
Wanni Feng,
Ang He,
Tuo Li,
Lina Wang,
Xiaolu Wang,
Xiali Rao,
Fangliang Gan Tags: Original Article Source Type: research
Model ‐Based Dose Selection of Fostemsavir for Pediatric Populations With Multidrug‐Resistant HIV‐1 and Relative Bioavailability Assessment in Healthy Adults
AbstractFostemsavir, a prodrug of the first-in-class HIV-1 attachment inhibitor temsavir, is approved for the treatment of multidrug-resistant HIV-1 in adults; its use in pediatric populations is currently being studied. Population pharmacokinetic modeling across pediatric weight bands was used to guide pediatric fostemsavir dose selection. Dosing simulations demonstrated that twice-daily fostemsavir 600-mg (adult dose) and 400-mg doses met safety and efficacy criteria for 35 kg or greater and 20 or greater to less than 35 kg pediatric weight bands, respectively. Temsavir relative bioavailability of 2 low-dose fostemsav...
Source: Clinical Pharmacology in Drug Development - June 17, 2023 Category: Drugs & Pharmacology Authors: Nilay Thakkar,
Mindy Magee,
Navin Goyal,
Judah Abberbock,
Chris Jones,
James Taylor,
Shiven Chabria,
Katy Moore Tags: Original Article Source Type: research
Pharmacokinetics and Bioequivalence of Mirogabalin Orally Disintegrating Tablets and Conventional Tablets in Healthy Japanese Participants
In conclusion, mirogabalin 15-mg ODTs, either with or wit hout water, were bioequivalent to conventional 15-mg tablets. (Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - June 14, 2023 Category: Drugs & Pharmacology Authors: Kaoru Toyama,
Takashi Eto,
Kanae Suzuki,
Sayaka Shinohara,
Satoshi Yoshiba,
Kazutaka Yoshihara,
Hitoshi Ishizuka Tags: Original Article Source Type: research
Bioequivalence Study of Miglitol Orally Disintegrating Tablets in Healthy Chinese Volunteers Under Fasting Condition Based on Pharmacodynamic and Pharmacokinetic Parameters
AbstractTo investigate the bioequivalence of miglitol orally disintegrating tablets in healthy Chinese volunteers based on pharmacodynamic (PD) and pharmacokinetic (PK) parameters. Additionally, the safety profile was estimated. Two randomized, open-label, single-dose, crossover trials were conducted under fasting conditions. In the PD trial (CTR20191811), 45 healthy volunteers were randomly divided into 3 groups in a 1:1:1 ratio and administered sucrose alone or coadministered with 50 mg of miglitol orally disintegrating tablet test or reference formulation/sucrose. In the PK trial (CTR20191696), 24 healthy volunteers w...
Source: Clinical Pharmacology in Drug Development - June 10, 2023 Category: Drugs & Pharmacology Authors: Ming ‐Xuan Zhao,
Jin‐Lian Wu,
Li‐Chun Dong,
Jing Chen,
Feng‐Jia Zhu,
Yu‐Xin Fan,
Juan Zhang,
Xiao‐Ping Zhang,
Ping Zhang,
Chong‐Jing Yu,
Meng‐Di Zhou,
Jian‐Chang He Tags: Original Article Source Type: research
