Investigation of Approval Trends and Benefits of New Fixed-Dose Combination Drugs in Japan.

Background: New fixed-dose combination drugs (FDCs) had been developed in limited numbers in Japan. Since regulatory requirements were relaxed in 2005, 73 new FDCs have been approved by PMDA since 2006. In this study, we investigate trends in new FDCs and their benefits through a questionnaire survey provided to patients and pharmacists.

NSAIDs may prevent EGFR-TKI-related skin rash in non-small cell lung cancer patients .

Objectives: Skin rash is a common adverse event induced by epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI). Here, we aimed to predict factors that reduce EGFR-TKI-related skin rash.

Materials And Methods: We conducted a single-center, retrospective study to predict factors that reduce skin rash in patients undergoing treatment for non-small cell lung cancer (NSCLC) with EGFR-TKIs using Cox proportional hazards model.

Influence of Drug Lag on New Drug Label Revisions.

Background: Drug lag (DL) in Japan has decreased in the last few years as a result of the globalization of drug development in the past decade, and new molecule entities (NMEs) with short DL are on the rise. The purpose of this study was to investigate the influence of DL on postmarketing safety of NMEs, by comparing the length of DL and the chronological trend of package insert revisions.

Methods: The number of label revisions occurring during 6 years after approval was investigated for 142 NMEs approved between 2000 and 2006.

Erratum to: Influence of nonsteroidal anti-inflammatory drugs on aspirin's antiplatelet effects and suggestion of the most suitable time for administration of both agents without resulting in interaction.

[This corrects the article DOI: 10.1186/s40780-017-0078-7.].

Influence of nonsteroidal anti-inflammatory drugs on aspirin's antiplatelet effects and suggestion of the most suitable time for administration of both agents without resulting in interaction.

Background: Low-dose aspirin irreversibly inhibits platelet cyclooxygenase-1 (COX-1) and suppresses platelet aggregation. It is effective for secondary prevention of cardiovascular events. Because nonsteroidal anti-inflammatory drugs (NSAIDs) reversibly bind with COX-1, the antiplatelet effects of aspirin may be suppressed when NSAIDs are co-administered.

Interaction between Bisphosphonates and Mineral Water: Study of Oral Risedronate Absorption in Rats.

Bisphosphonates are antiosteoporotic agents prescribed for patients with osteoporosis. Drug package inserts for bisphosphonate supplements indicate that their bioavailability is reduced by high levels of metal cations (Ca(2+), Mg(2+), etc.).

Serum concentrations of clarithromycin and rifampicin in pulmonary Mycobacterium avium complex disease: long-term changes due to drug interactions and their association with clinical outcomes.

Background: Concomitant use of clarithromycin (CAM) and rifampicin (RFP) for the treatment of pulmonary Mycobacterium avium complex (MAC) disease affects the systemic concentrations of both drugs due to CYP3A4-related interactions. To date, however, there has been no report that investigates the long-term relationship between the drug concentrations, CYP3A4 activity, and clinical outcomes. Our aim was to investigate the time course of the drug levels in long-term treatment of subjects with pulmonary MAC disease, and examine the correlation of these concentrations with CYP3A4 activity and clinical outcomes.

Retrospective investigation of combination therapy with clarithromycin and levofloxacin for pulmonary Mycobacterium avium complex disease.

Background: Fluoroquinolones are often used for the treatment of refractory Mycobacterium avium complex (MAC) disease when the clinical efficacy of the recommended regimen, which includes clarithromycin (CAM), rifampicin (RFP), and ethambutol (EB), is insufficient. However, recent in vitro and in vivo studies have suggested that fluoroquinolones decreased the antibacterial activity of CAM when they were administered in combination. In this study, we retrospectively investigated the influence of the combination of CAM and levofloxacin (LVFX) on clinical outcomes for pulmonary MAC disease patients.

Influence of Food on Rifampicin Pharmacokinetics in Rats.

Rifampicin (RFP; 30 mg/kg) was orally administered to fasted or fed rats using ultrapure water as the vehicle, and the influence of food on its pharmacokinetics was investigated. To examine the influence of intragastric pH and RFP solubility, similar experiments were performed using 0.1 M HCl (pH 1.

Helices F-G are important for the substrate specificities of CYP3A7.

CYP3A7 is a member of the human CYP3A family and a major form of P450 expressed in human fetal livers. Although CYP3A7 shares nearly 90% base sequence with CYP3A4, CYP3A7 shows striking functional differences in the catalytic preference for several substrates, such as dehydroepiandrosterone (DHEA) or dehydroepiandrosterone 3-sulfate (DHEA-3S). First, to clarify the reason for the differences between CYP3A7 and CYP3A4, a homology model of CYP3A7 was constructed using the CYP3A4 crystal structure.