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Application of Bootstrap f < sub > 2 < /sub > to Dissolution Data From Biorelevant Media and Evidence of the Conservative Nature of Bootstrap f < sub > 2 < /sub >
The objective was to compare outcomes from bootstrap f2 and f2 (i.e. not-bootstrapped f2) using a large set of in vitro dissolution data. Non-parametric bootstrapping was performed on the 104 profile comparisons that did not meet the percent coefficient of variation (CV%) criteria to use average dissolution data. Bootstrap f2 was taken as the lower 90% confidence interval of bootstrapped samples. There was concordance between bootstrap f2 and f2 in 92 of the 104 comparisons (88%). There were no false positives. However, 12% were false negative. Inspection of these discordance pairs suggests that bootstrap f2 serves as a co...
Source: European Journal of Pharmaceutical Sciences - March 12, 2024 Category: Drugs & Pharmacology Authors: Raqeeb Jamil James E Polli Source Type: research

Population Pharmacokinetic/Pharmacodynamic Modeling of H018, a Selective JAK1 Inhibitor, in Healthy Chinese Volunteers
Eur J Pharm Sci. 2024 Mar 9:106747. doi: 10.1016/j.ejps.2024.106747. Online ahead of print.ABSTRACTH018 is an orally administered, selective, small-molecule inhibitor of Janus kinase 1 (JAK1) made for the treatment of rheumatoid arthritis. A population pharmacokinetic/pharmacodynamic analysis was conducted to characterize the pharmacokinetic and pharmacodynamic profile of H018 and its active metabolite using data from 48 healthy Chinese volunteers who received a single dose of 10-160 mg of H018 in a phase I clinical study. A two-compartment model with delayed absorption and linear elimination adequately described the pharm...
Source: European Journal of Pharmaceutical Sciences - March 11, 2024 Category: Drugs & Pharmacology Authors: Yuchen Qu Wenjia Zhou Meng Wang Quanying Zhang Mei Su Jie Pan Source Type: research

Regional lung targeting with a fluticasone/salmeterol aerosol using a bolus breath hold method of the PreciseInhale ® system: A first evaluation in humans
CONCLUSIONS: When one inhaler dose was administered via the PI system, the absorbed dose, expressed as AUC24, was approximately twice as high and the CV was less than half, compared to direct inhalation from the same pMDI. Bolus breath hold targeting of drugs from the same aerosol mixture to the peripheral lung and the central airways showed a difference in their appearance in the systemic circulation. Normalized to the same deposited dose, SMX had a 57% higher Cmax in the peripheral lung compared to the central airways. However, from 6 to 24 h after dosing the systemic concentrations of SMX from both regions were quite si...
Source: European Journal of Pharmaceutical Sciences - March 9, 2024 Category: Drugs & Pharmacology Authors: Per Gerde Carl-Olof Sj öberg Helen B äckroos Joakim Englund Marit Wangheim Helena Litorp Source Type: research

Environmental considerations along the life cycle of pharmaceuticals: Interview study on views regarding environmental challenges, concerns, strategies, and prospects within the pharmaceutical industry
Eur J Pharm Sci. 2024 Mar 7:106743. doi: 10.1016/j.ejps.2024.106743. Online ahead of print.ABSTRACTEnvironmental impacts of medicines arise throughout their entire life cycle. The pharmaceutical industry has a key role in reducing these impacts in early production phases, but currently has limited possibilities to reduce the environmental exposure arising from drug consumption and end-of-life. The aim of this interview study was to explore the current environmental actions within the industry, as well as the views and attitudes toward the strategies to address the environmental challenges and concerns. Semi-structured inte...
Source: European Journal of Pharmaceutical Sciences - March 9, 2024 Category: Drugs & Pharmacology Authors: Sanja Riikonen Johanna Timonen Tiina Sikanen Source Type: research

Open Forum Conference on the ICH M13A Bioequivalence Guideline
Discussion Forum on the ICH M13A draft "Guideline on bioequivalence for immediate-release solid oral dosage forms". This conference was cosponsored by the Arbeitsgemeinschaft Pharmazeutische Verfahrenstechnik (APV) and the Frankfurt Foundation Quality of Medicines. Scientists from academia and industry attended this workshop on May 15, 2023, in Frankfurt/Germany, to discuss the suggested regulations with the European members of the ICH drafting group. The aim of this report is to summarise and highlight the main discussion points such as choice of study population (females and/or males), request for fasted and/or fed studi...
Source: European Journal of Pharmaceutical Sciences - March 7, 2024 Category: Drugs & Pharmacology Authors: Henning Blume Steven Wedemeyer Anne Seidlitz Gerald Beuerle Sandra Klein Erem Bilensoy Source Type: research

The 2-aminoethyl diphenylborinate-based fluorescent method identifies quercetin and luteolin metabolites as substrates of Organic anion transporting polypeptides, OATP1B1 and OATP2B1
Eur J Pharm Sci. 2024 Mar 2:106740. doi: 10.1016/j.ejps.2024.106740. Online ahead of print.ABSTRACTOrganic anion transporting polypeptides (OATPs), OATP1B1 and OATP2B1 are membrane proteins mediating the cellular uptake of chemically diverse organic compounds. OATP1B1 is exclusively expressed in hepatocytes and plays a key role in hepatic detoxification. The ubiquitously expressed OATP2B1 promotes the intestinal absorption of orally administered drugs. Flavonoids are widely found in foods and beverages, and many of them can inhibit OATP function, resulting in food-drug interactions. In our previous work, we have shown that...
Source: European Journal of Pharmaceutical Sciences - March 4, 2024 Category: Drugs & Pharmacology Authors: Hana Kaci Éva Bakos Paul W Needs Paul A Kroon Kate řina Valentová Mikl ós Poór Csilla Özvegy-Laczka Source Type: research

Virtual Special Issue of Nordic POP: Patient-Oriented Products
Eur J Pharm Sci. 2024 Mar 1:106737. doi: 10.1016/j.ejps.2024.106737. Online ahead of print.NO ABSTRACTPMID:38432548 | DOI:10.1016/j.ejps.2024.106737 (Source: European Journal of Pharmaceutical Sciences)
Source: European Journal of Pharmaceutical Sciences - March 3, 2024 Category: Drugs & Pharmacology Authors: Jessica M Rosenholm G øril Eide Flaten Alexandra Teleki Source Type: research

Screening of 16 major drug glucuronides for time-dependent inhibition of nine drug-metabolizing CYP enzymes - detailed studies on CYP3A inhibitors
In conclusion, we identified several glucuronide metabolites with CYP inhibitory properties. Based on detailed experiments, the inactivation of CYP3A by carvedilol may cause clinically significant drug-drug interactions.PMID:38423227 | DOI:10.1016/j.ejps.2024.106735 (Source: European Journal of Pharmaceutical Sciences)
Source: European Journal of Pharmaceutical Sciences - February 29, 2024 Category: Drugs & Pharmacology Authors: Helin ä Kahma Marie-No ëlle Paludetto Mikko Neuvonen Mika Kurkela Anne M Filppula Mikko Niemi Janne T Backman Source Type: research