International Journal of Clinical Pharmacology and Therapeutics This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Subcutaneous infliximab CT-P13 without intravenous induction in psoriatic arthritis: A case report and pharmacokinetic considerations
CONCLUSION: SC infliximab was successfully used without previous IV infusion induction. Although, to date, the induction of PsA treatment via the SC route is not foreseen, the known pharmacokinetic properties and the outcome improvements observed in our patient show that subcutaneous treatment induction, as is already done in the treatment of rheumatoid arthritis, is also possible.PMID:38214148 | DOI:10.5414/CP204388 (Source: International Journal of Clinical Pharmacology and Therapeutics)
Source: International Journal of Clinical Pharmacology and Therapeutics - January 12, 2024 Category: Drugs & Pharmacology Authors: Maria Chiara Ditto Simone Parisi Valentina Cotugno Diego Antonio Barila Luca Lo Sardo Francesco Cattel Enrico Fusaro Source Type: research

Hoarding of insulin and oral antidiabetics in the first phase of  the COVID-19 pandemic: Regulatory actions taken to avoid shortage
CONCLUSION: A signal of insulin hoarding was detected early in the COVID-19 pandemic. A temporary regulation, reducing dispensing to a maximum supply of 3 months was rapidly implemented. A shortage of vitally important prescribed medicines was avoided.PMID:38174883 | DOI:10.5414/CP204450 (Source: International Journal of Clinical Pharmacology and Therapeutics)
Source: International Journal of Clinical Pharmacology and Therapeutics - January 4, 2024 Category: Drugs & Pharmacology Authors: Bj örn Zethelius Anders Sundstr öm Kenneth Nordback Karl-Mikael K älkner Rickard Ljung Source Type: research

Can non-renal clearance and/or bioavailability of drugs be assessed reliably in renal impairment studies with oral drug administration?
CONCLUSION: A reliable assessment of the impact of CKD on CLnr for drugs with significant non-renal elimination requires information after oral and intravenous administration in the same DRIS study. However, apparently accurate estimates of F for drugs with negligible non-renal elimination may be obtained in DRIS with oral drug administration only, but validation of the proposed method with other drugs exhibiting negligible non-renal elimination and variable F1 is required.PMID:38174884 | DOI:10.5414/CP204451 (Source: International Journal of Clinical Pharmacology and Therapeutics)
Source: International Journal of Clinical Pharmacology and Therapeutics - January 4, 2024 Category: Drugs & Pharmacology Authors: Yichao Yu Peter H Hinderling Source Type: research

Pharmacokinetics and bioequivalence of tofacitinib 5 mg in healthy Korean male subjects
CONCLUSION: In healthy Korean male adult subjects, the pharmacokinetic parameters of tofacitinib free base and tofacitinib citrate were evaluated and met the pharmacokinetic bioequivalent criteria. Both formulations were safe and well-tolerated.PMID:38174885 | DOI:10.5414/CP204480 (Source: International Journal of Clinical Pharmacology and Therapeutics)
Source: International Journal of Clinical Pharmacology and Therapeutics - January 4, 2024 Category: Drugs & Pharmacology Authors: Ji-Hyoung Lee Ji-Young Jeon Kyungho Jang Sung Kwon Kang Yong-Geun Kwak Seol Ju Moon Min-Gul Kim Source Type: research

Comparison of SB17 and reference ustekinumab in healthy adults: A  randomized, double-blind, single-dose, phase I study
CONCLUSION: This study demonstrated bioequivalence of SB17, EU-UST, and US-UST in terms of PK. Safety, tolerability, and immunogenicity were also comparable between all groups.PMID:38174886 | DOI:10.5414/CP204492 (Source: International Journal of Clinical Pharmacology and Therapeutics)
Source: International Journal of Clinical Pharmacology and Therapeutics - January 4, 2024 Category: Drugs & Pharmacology Authors: Hansol Jeong Taeseung Kang Jiyoon Lee Seongsik Im Source Type: research

Hoarding of insulin and oral antidiabetics in the first phase of  the COVID-19 pandemic: Regulatory actions taken to avoid shortage
CONCLUSION: A signal of insulin hoarding was detected early in the COVID-19 pandemic. A temporary regulation, reducing dispensing to a maximum supply of 3 months was rapidly implemented. A shortage of vitally important prescribed medicines was avoided.PMID:38174883 | DOI:10.5414/CP204450 (Source: International Journal of Clinical Pharmacology and Therapeutics)
Source: International Journal of Clinical Pharmacology and Therapeutics - January 4, 2024 Category: Drugs & Pharmacology Authors: Bj örn Zethelius Anders Sundstr öm Kenneth Nordback Karl-Mikael K älkner Rickard Ljung Source Type: research

Can non-renal clearance and/or bioavailability of drugs be assessed reliably in renal impairment studies with oral drug administration?
CONCLUSION: A reliable assessment of the impact of CKD on CLnr for drugs with significant non-renal elimination requires information after oral and intravenous administration in the same DRIS study. However, apparently accurate estimates of F for drugs with negligible non-renal elimination may be obtained in DRIS with oral drug administration only, but validation of the proposed method with other drugs exhibiting negligible non-renal elimination and variable F1 is required.PMID:38174884 | DOI:10.5414/CP204451 (Source: International Journal of Clinical Pharmacology and Therapeutics)
Source: International Journal of Clinical Pharmacology and Therapeutics - January 4, 2024 Category: Drugs & Pharmacology Authors: Yichao Yu Peter H Hinderling Source Type: research

Pharmacokinetics and bioequivalence of tofacitinib 5 mg in healthy Korean male subjects
CONCLUSION: In healthy Korean male adult subjects, the pharmacokinetic parameters of tofacitinib free base and tofacitinib citrate were evaluated and met the pharmacokinetic bioequivalent criteria. Both formulations were safe and well-tolerated.PMID:38174885 | DOI:10.5414/CP204480 (Source: International Journal of Clinical Pharmacology and Therapeutics)
Source: International Journal of Clinical Pharmacology and Therapeutics - January 4, 2024 Category: Drugs & Pharmacology Authors: Ji-Hyoung Lee Ji-Young Jeon Kyungho Jang Sung Kwon Kang Yong-Geun Kwak Seol Ju Moon Min-Gul Kim Source Type: research

Comparison of SB17 and reference ustekinumab in healthy adults: A  randomized, double-blind, single-dose, phase I study
CONCLUSION: This study demonstrated bioequivalence of SB17, EU-UST, and US-UST in terms of PK. Safety, tolerability, and immunogenicity were also comparable between all groups.PMID:38174886 | DOI:10.5414/CP204492 (Source: International Journal of Clinical Pharmacology and Therapeutics)
Source: International Journal of Clinical Pharmacology and Therapeutics - January 4, 2024 Category: Drugs & Pharmacology Authors: Hansol Jeong Taeseung Kang Jiyoon Lee Seongsik Im Source Type: research

Hoarding of insulin and oral antidiabetics in the first phase of  the COVID-19 pandemic: Regulatory actions taken to avoid shortage
CONCLUSION: A signal of insulin hoarding was detected early in the COVID-19 pandemic. A temporary regulation, reducing dispensing to a maximum supply of 3 months was rapidly implemented. A shortage of vitally important prescribed medicines was avoided.PMID:38174883 | DOI:10.5414/CP204450 (Source: International Journal of Clinical Pharmacology and Therapeutics)
Source: International Journal of Clinical Pharmacology and Therapeutics - January 4, 2024 Category: Drugs & Pharmacology Authors: Bj örn Zethelius Anders Sundstr öm Kenneth Nordback Karl-Mikael K älkner Rickard Ljung Source Type: research

Can non-renal clearance and/or bioavailability of drugs be assessed reliably in renal impairment studies with oral drug administration?
CONCLUSION: A reliable assessment of the impact of CKD on CLnr for drugs with significant non-renal elimination requires information after oral and intravenous administration in the same DRIS study. However, apparently accurate estimates of F for drugs with negligible non-renal elimination may be obtained in DRIS with oral drug administration only, but validation of the proposed method with other drugs exhibiting negligible non-renal elimination and variable F1 is required.PMID:38174884 | DOI:10.5414/CP204451 (Source: International Journal of Clinical Pharmacology and Therapeutics)
Source: International Journal of Clinical Pharmacology and Therapeutics - January 4, 2024 Category: Drugs & Pharmacology Authors: Yichao Yu Peter H Hinderling Source Type: research

Pharmacokinetics and bioequivalence of tofacitinib 5 mg in healthy Korean male subjects
CONCLUSION: In healthy Korean male adult subjects, the pharmacokinetic parameters of tofacitinib free base and tofacitinib citrate were evaluated and met the pharmacokinetic bioequivalent criteria. Both formulations were safe and well-tolerated.PMID:38174885 | DOI:10.5414/CP204480 (Source: International Journal of Clinical Pharmacology and Therapeutics)
Source: International Journal of Clinical Pharmacology and Therapeutics - January 4, 2024 Category: Drugs & Pharmacology Authors: Ji-Hyoung Lee Ji-Young Jeon Kyungho Jang Sung Kwon Kang Yong-Geun Kwak Seol Ju Moon Min-Gul Kim Source Type: research

Comparison of SB17 and reference ustekinumab in healthy adults: A  randomized, double-blind, single-dose, phase I study
CONCLUSION: This study demonstrated bioequivalence of SB17, EU-UST, and US-UST in terms of PK. Safety, tolerability, and immunogenicity were also comparable between all groups.PMID:38174886 | DOI:10.5414/CP204492 (Source: International Journal of Clinical Pharmacology and Therapeutics)
Source: International Journal of Clinical Pharmacology and Therapeutics - January 4, 2024 Category: Drugs & Pharmacology Authors: Hansol Jeong Taeseung Kang Jiyoon Lee Seongsik Im Source Type: research

Hoarding of insulin and oral antidiabetics in the first phase of  the COVID-19 pandemic: Regulatory actions taken to avoid shortage
CONCLUSION: A signal of insulin hoarding was detected early in the COVID-19 pandemic. A temporary regulation, reducing dispensing to a maximum supply of 3 months was rapidly implemented. A shortage of vitally important prescribed medicines was avoided.PMID:38174883 | DOI:10.5414/CP204450 (Source: International Journal of Clinical Pharmacology and Therapeutics)
Source: International Journal of Clinical Pharmacology and Therapeutics - January 4, 2024 Category: Drugs & Pharmacology Authors: Bj örn Zethelius Anders Sundstr öm Kenneth Nordback Karl-Mikael K älkner Rickard Ljung Source Type: research

Can non-renal clearance and/or bioavailability of drugs be assessed reliably in renal impairment studies with oral drug administration?
CONCLUSION: A reliable assessment of the impact of CKD on CLnr for drugs with significant non-renal elimination requires information after oral and intravenous administration in the same DRIS study. However, apparently accurate estimates of F for drugs with negligible non-renal elimination may be obtained in DRIS with oral drug administration only, but validation of the proposed method with other drugs exhibiting negligible non-renal elimination and variable F1 is required.PMID:38174884 | DOI:10.5414/CP204451 (Source: International Journal of Clinical Pharmacology and Therapeutics)
Source: International Journal of Clinical Pharmacology and Therapeutics - January 4, 2024 Category: Drugs & Pharmacology Authors: Yichao Yu Peter H Hinderling Source Type: research