Pharmacokinetics Definitions in Regulatory Documents: Transfer from Small Molecules into Biologics

Grabowski, Tomasz; Marczak, Monika; Okoniewska, Krystyna

doi:10.4155/ipk-2016-0012

Cited by 6 publications

(5 citation statements)

References 5 publications

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“…All animals received an IV dose (20 mg/kg body weight OTC) for absolute bioavailability calculation. A 53 hr washout period (corresponding to 10 half-life) was left between treatments (del Castillo et al, 1998;Grabowski, Marczak, & Okoniewska, 2016).…”

Section: Experimental Designmentioning

confidence: 99%

Impact of water hardness on oxytetracycline oral bioavailability in fed and fasted piglets

Decundo

Dieguez

Martínez

et al. 2019

Veterinary Medicine & Sci

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Water hardness is a critical factor that affects oxytetracycline dissolution by chelation with cations. These interactions may lead to impaired dosing and consequently decrease absorption. Moreover, feed present in gastrointestinal tract may interact with antibiotic and alter pharmacokinetic parameters. In the present study, dissolution profiles of an oxytetracycline veterinary formulation were assessed in purified, soft and hard water. Furthermore, oxytetracycline absolute bioavailability, after oral administration of the drug dissolved in soft or hard water, was evaluated in fed and fasted piglets. A maximum dissolution of 86% and 80% was obtained in soft and hard water, respectively, while in purified water dissolution was complete. Results from in vivo study reconfirmed oxytetracycline's very low oral bioavailability. The greatest values were attained when antibiotic was dissolved in soft water and in fasted animals. Statistically significant lower absolute bioavailability was achieved when hard water was used and/or animals were fed. Moreover, Cmax attained in all treatments was lower than MIC90 of most important swine pathogens. For these reasons, the oral use of OTC formulations, that have demonstrated low oral bioavailability, should be avoided to treat systemic diseases in pigs.

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Section: Experimental Designmentioning

confidence: 99%

Impact of water hardness on oxytetracycline oral bioavailability in fed and fasted piglets

Decundo

Dieguez

Martínez

et al. 2019

Veterinary Medicine & Sci

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“…Anti-estrogen therapy was finished 6 months before the study began. Given that the half-life of tamoxifen after chronic dosing is 7 days ( 33 ), the washout period for our patient ended at the latest ~4 months before study start ( 34 ). Thus, the patient's previous tamoxifen use cannot have affected the findings of this study.…”

Section: Case Descriptionmentioning

confidence: 99%

Case Report: Dynamic Interdependencies Between Complementary and Alternative Medicine (CAM) Practice, Urinary Interleukin-6 Levels, and Fatigue in a Breast Cancer Survivor

et al. 2021

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Background: This study investigated the influence of complementary and alternative medicine (CAM) techniques (i.e., Jin Shin Jyutsu, music, physiotherapy, Tai Chi, and energy healing) on urinary interleukin-6 (IL-6) levels and fatigue in a 49-year-old breast cancer survivor suffering from cancer-related fatigue and depression. Data were sampled under conditions of “life as it is lived.”Methods: For 28 days, a female breast cancer survivor collected her full urine output in 12-h intervals from about 8 a.m. to 8 p.m. and from about 8 p.m. to 8 a.m. These urine samples were used to determine urinary IL-6 levels through ELISA and creatinine concentrations via HPLC. In 12-h intervals (every morning and evening), the patient completed the DIARI, which included fatigue measurement and notes on incidents and activities such as CAM practice. In addition, the patient was interviewed weekly to identify meaningful everyday incidents. In this context, CAM practice was also discussed. Time series analysis consisted of ARIMA modeling and cross-correlational analyses (p < 0.05).Results: When each CAM technique was considered separately in time series analysis, CAM was consistently associated with increases in urinary IL-6 release and decreases in fatigue. Furthermore, when all CAM techniques experienced as positive were included in one time series, a biphasic urinary IL-6 response pattern was found in which CAM practice was first preceded by decreases in IL-6 by 12–0 h and then followed by increases in IL-6 after 108–120 h. Finally, cross-correlations between IL-6 and fatigue showed that increases in IL-6 were followed by decreases in fatigue intensity after 48–60 h and, conversely, that decreases in fatigue intensity were followed by decreases in IL-6 after 24–36 h and 48–60 h.Conclusion: IL-6 increases and fatigue decreases highlight potential health-promoting effects of CAM practice. Moreover, a cyclic IL-6 pattern in response to all CAM activities experienced as positive underscores that CAM was meaningful to the patient. Additionally, a negative feedback circuit between IL-6 and fatigue intensity was detected. Taken together, this study confirms the necessity of integrating subjective meaning and dynamic complexity into biopsychosocial research in order to understand human functioning under real-life conditions.

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“…47 Usually, the proposed wash-out period of a drug is estimated at 5 to 10 times of its elimination half-life, a fact which means that for a longer t 1/2 el of a biologic a prolonged wash-out period might be required. 48 However, a more rapid initiation of the new agent may be essential for more symptomatic patients and patients experiencing frequent exacerbations and this might lead to assumptions regarding the safety of such an early administration. This concern has been partially resolved by the 'Omalizumab Switch to MepOlizumab' (OSMO) study, which aimed to assess whether patients with asthma eligible for both omalizumab and mepolizumab therapy, but not optimally controlled with omalizumab, would experience improvements in asthma control when switched directly to mepolizumab.…”

Section: How S Hould Switching B Een Performedmentioning

confidence: 99%

“…Elimination half‐life (t 1/2 el) for the five biologics approved for the treatment of severe asthma varies from 15 to 25 days (24 to 26 days for Omalizumab, 25 to 30 days for Reslizumab, 16 to 22 days for Mepolizumab, and approximately 15 and 26 days for Benralizumab and Dupilumab, respectively) 47 . Usually, the proposed wash‐out period of a drug is estimated at 5 to 10 times of its elimination half‐life, a fact which means that for a longer t 1/2 el of a biologic a prolonged wash‐out period might be required 48 . However, a more rapid initiation of the new agent may be essential for more symptomatic patients and patients experiencing frequent exacerbations and this might lead to assumptions regarding the safety of such an early administration.…”

Section: How Should Switching Been Performedmentioning

confidence: 99%

Switching between biologics in severe asthma patients. When the first choice is not proven to be the best

Papaioannou

Fouka

Papakosta

et al. 2020

Clin Experimental Allergy

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During the last decades, new treatments targeting disease mechanisms referred as biologics have been introduced in the therapy of asthma, resulting in a revolution in disease control and medical history. These treatments include monoclonal antibodies, recombinant cytokines and fusion proteins, with the former to be, at the moment, the only approved biological therapy for severe refractory asthma, also included in the disease recommendations. 1 To date, five monoclonal antibodies have been approved for the treatment of asthma. Omalizumab, the first biologic drug approved for the treatment of severe allergic asthma, is a recombinant humanized monoclonal antibody that selectively targets circulating IgE and blocks it from binding to its receptor found on mast cells and basophils. Omalizumab interrupts the IgE mediated asthma inflammatory cascade at an early stage 2 and thus, interrupts both early and late asthmatic responses. 3,4 Mepolizumab and reslizumab both target IL-5, which is a key component in eosinophil proliferation, activation and recruitment, preventing consequently its binding to the α-chain of the IL-5 receptor (IL-5α) on eosinophils. 5,6 Benralizumab targets directly IL-5Rα in all cells that express the receptor, such as eosinophils, basophils and mast cells, resulting not only in the blockade of IL-5 mediated survival of these cells but also in a direct eosinophil apoptosis augmentation, via antibody-dependant cell-mediated cytotoxity (ADCC) induced by the enhanced activation of the FcγRIIIa part of the IL-5Rα receptor of mature natural-killer (NK) cells and macrophages, leading in a near depletion of peripheral eosinophils. 7,8 All three

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Pharmacokinetics Definitions in Regulatory Documents: Transfer from Small Molecules into Biologics

Cited by 6 publications

References 5 publications

Impact of water hardness on oxytetracycline oral bioavailability in fed and fasted piglets

Impact of water hardness on oxytetracycline oral bioavailability in fed and fasted piglets

Case Report: Dynamic Interdependencies Between Complementary and Alternative Medicine (CAM) Practice, Urinary Interleukin-6 Levels, and Fatigue in a Breast Cancer Survivor

Switching between biologics in severe asthma patients. When the first choice is not proven to be the best

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