Development of a highly sensitive and specific two-site enzyme immunoassay for parathyroid hormone (1-34): Application to pharmacokinetic study on intranasal parathyroid hormone (1-34) in human

Kohno, Takeyuki; Murasugi, Noriaki; Watabe, Kazuhito; Nakamuta, Hiromichi; Koida, Masao; Sugie, Yohko; Nomura, Masakatsu; Yanagawa, Akira

doi:10.1002/(sici)1098-2825(1998)12:5<268::aid-jcla3>3.0.co;2-2

Cited by 8 publications

(6 citation statements)

References 28 publications

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“…Previously, the pharmacokinetics of rhPTH(1–34) had been extensively investigated in human beings [12–16], rats, dogs and monkeys [17,18]. After the subcutaneous administration of rhPTH(1–34) 10, 20 and 40 μg/kg in human beings, it was rapidly absorbed and reached the maximum plasma concentration after about 30 min., as well as rapidly eliminated with a half‐life ( t 1/2 ) of 1 hr [12,19].…”

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confidence: 99%

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Recombinant Human Parathyroid Hormone after Single‐ and Multiple‐Dose Subcutaneous Administration in Healthy Chinese Volunteers

Liu

Shi

et al. 2011

Basic Clin Pharma Tox

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Recombinant human parathyroid hormone ] represents a new class of anabolic agents for the treatment of osteoporosis. The present study was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of rhPTH(1-84) after single-and multiple-dose subcutaneous administration in healthy Chinese volunteers. Six cohorts of 32 volunteers received a single dose of rhPTH(1-84) at 0.5-5.0 lg ⁄ kg, and two cohorts of 12 volunteers received 2.0 and 3.0 lg ⁄ kg of rhPTH(1-84) once daily for 7 consecutive days to assess its safety and tolerability. The results indicated that rhPTH(1-84) appeared to be safe and well tolerated. Additionally, pharmacokinetics of rhPTH (1-84) -84) and rhPTH(1-34) were found to be dose proportional. The pharmacokinetic parameters for rhPTH(1-84) and rhPTH(1-34) after administration of multiple doses of 2.0 lg ⁄ kg were as follows: C ss_max = (164.96 € 52.61) and (75.05 € 7.31) pg ⁄ mL; C ss_min = (6.99 € 7.73) and (2.05 € 2.82) pg ⁄ mL; AUC ss = (567.26 € 118.41) and (306.02 € 77.55) pg hr ⁄ mL; t 1 ⁄ 2 = (1.81 € 0.89) and (2.27 € 1.11) hr; DF = (6.93 € 2.64) and (6.00 € 1.37), respectively. After multiple doses, the pharmacokinetic parameters for rhPTH(1-84) were consistent with those after single dose. However, the mean C max and AUC 0-10 of rhPTH(1-34) after multiple dosing were significantly higher than the corresponding values obtained after single-dose administration. Serum total calcium and phosphate concentrations increased and decreased significantly at 4 hr post-dosing, respectively.

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confidence: 99%

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Recombinant Human Parathyroid Hormone after Single‐ and Multiple‐Dose Subcutaneous Administration in Healthy Chinese Volunteers

Liu

Shi

et al. 2011

Basic Clin Pharma Tox

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“…To test the applicability of this method, we examined the usefulness of novel mucosal vaccine formulae that used CaCO3 and MgO. CaCO3 and Mg0 are used as absorption promoters in nasal formulae and substantially improve the extent of the bioavailability of hormones and other peptide drugs (10,11). In this study, they were used as carriers in the digestive tract to deliver vaccine antigen.…”

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confidence: 99%

Assessment of Mucosal Immune Response in Genitourinary Tract Using Urine

Kohno

Tanaka

Watabe

et al. 1999

Microbiology and Immunology

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A novel method to assess mucosal immune response in the genitourinary mucosa after immunization with a mucosal vaccine has been developed. In this method, secretory IgA antibody is measured by a highly sensitive enzyme immunoassay (immune-complex transfer enzyme immunoassay) using urine as a specimen. The urinary IgA antibody response could be detected by the immune-complex transfer enzyme immunoassay. In contrast, a conventional enzyme immunoassay (enzyme-linked immunosorbent assay (ELISA)) could not detect this response because of its low sensitivity. Because urine samples can be collected easily and nontraumatically, not only from experimental animals but also from humans, both males and females, the present method may be applicable for assessing the protective efficacy of candidates for mucosal vaccines against sexually transmitted microorganisms, such as human immunodeficiency virus. Furthermore, the usefulness of this method for novel mucosal vaccine formulae was shown for a model in which vaccine antigen and Bordetella pertussis adjuvant were adsorbed onto CaCO3 and enclosed in enteric coated capsules .

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“…Specifically, catabolic activity has been assigned to continuous infusion of PTH, as opposed to increased osteoblast effects caused by intermittent PTH injection [13]. Reports have found that PTH activity resides mainly within the 1-34 N-terminal fragment [14]. Synthetic recombinant human PTH 1-34 amino-terminal fragment of parathyroid hormone (PTH1-34) has been shown to participate in the treatment of severe osteoporosis, as it is the only clinically approved drug with osteoanabolic properties [15].…”

Section: Introductionmentioning

confidence: 99%

Intermittent Administration of Parathyroid Hormone Enhances Odonto/Osteogenic Differentiation of Stem Cells from the Apical Papilla via JNK and P38 MAPK Pathways

Pang

Zhuang

et al. 2020

Stem Cells International

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Objective. Parathyroid hormone (PTH) is considered to be essential during the tooth development. Stem cells from the apical papilla (SCAPs) are responsible for dentine formation. However, the interaction between PTH and SCAPs remains unclear. This study was aimed at investigating the effects of PTH on odonto/osteogenic differentiation capacity of SCAPs and elucidating the underlying molecular mechanisms. Materials and Methods. Here, SCAPs were isolated and identified in vitro. Effects of PTH on the proliferation of SCAPs were determined by Cell Counting Kit-8 (CCK-8), flow cytometry (FCM), and EdU. Alkaline phosphatase (ALP) activity, alizarin red staining, Western blot, and RT-PCR were carried out to detect the odonto/osteogenic differentiation of PTH-treated SCAPs as well as the participation of the MAPK signaling pathway. Results. An ALP activity assay determined that 10-8 mol/L PTH was the optimal concentration for the induction of SCAPs with no significant influence on the proliferation of SCAPs as indicated by CCK-8, FCM, and EdU. The expression of odonto/osteogenic markers was significantly upregulated in mRNA levels and protein levels. Moreover, intermittent treatment of PTH also increased phosphorylation of JNK and P38, and the differentiation was suppressed following the inhibition of JNK and P38 MAPK pathways. Conclusion. PTH can regulate the odonto/osteogenic differentiation of SCAPs via JNK and P38 MAPK pathways.

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Development of a highly sensitive and specific two-site enzyme immunoassay for parathyroid hormone (1-34): Application to pharmacokinetic study on intranasal parathyroid hormone (1-34) in human

Cited by 8 publications

References 28 publications

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Recombinant Human Parathyroid Hormone after Single‐ and Multiple‐Dose Subcutaneous Administration in Healthy Chinese Volunteers

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Recombinant Human Parathyroid Hormone after Single‐ and Multiple‐Dose Subcutaneous Administration in Healthy Chinese Volunteers

Assessment of Mucosal Immune Response in Genitourinary Tract Using Urine

Intermittent Administration of Parathyroid Hormone Enhances Odonto/Osteogenic Differentiation of Stem Cells from the Apical Papilla via JNK and P38 MAPK Pathways

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