Development of a Translational Exposure-Bracketing Approach to Streamline the Development of Hormonal Contraceptive Drug Products
Clin Pharmacol Ther. 2022 Jun 20. doi: 10.1002/cpt.2690. Online ahead of print.ABSTRACTWorldwide, 922 million women of reproductive age (or their partners) use some sort of contraception to prevent pregnancy. Oral combined hormonal contraceptives (CHC) typically utilize a combination of a progestin and an estrogen. CHC are potentially at risk to metabolic drug-drug interaction (DDI) via CYP3A4, the main enzyme involved in the oxidative metabolism of ethinyl estradiol (EE) and most progestins, e.g. levonorgestrel (LNG) and drospirenone (DRSP). Recently, the FDA issued a guidance addressing metabolic DDIs in the realm of CHC...
Source: Clinical Pharmacology and Therapeutics - June 20, 2022 Category: Drugs & Pharmacology Authors: Brian Cicali Lais Da Silva Amir Sarayani Karthik Lingineni Michelle Pressly Soyoung Kim Thomas Wendl Joachim Hoechel Valvanera Vozmediano Almut G Winterstein Joshua D Brown Stephan Schmidt Rodrigo Cristofoletti Source Type: research
Ziritaxestat Drug-Drug Interaction with Oral Contraceptives: Role of SULT1E1 Inhibition
Clin Pharmacol Ther. 2022 Jun 17. doi: 10.1002/cpt.2689. Online ahead of print.ABSTRACTIn vitro signals indicate that ziritaxestat is a weak cytochrome P450 (CYP) 3A4 inhibitor and inducer. Therefore, potential drug-drug interactions (DDIs) with oral contraceptives were examined at a time when ziritaxestat was under development for treatment of fibrotic diseases. This open-label, crossover (fixed sequence) DDI study enrolled healthy, non-pregnant females aged 18-65 years (n=15) who were using highly effective contraception such as a non-hormonal intrauterine device, bilateral tubal occlusion or sexual abstinence. A single ...
Source: Clinical Pharmacology and Therapeutics - June 17, 2022 Category: Drugs & Pharmacology Authors: Eric Helmer Negin Karimian Karen Van Assche Ineke Seghers Sandrine Le Tallec Ganesh Cherala Graham Scott Florence S Namour Source Type: research
Effects of continuous-combined oral drospirenone- estradiol on blood pressure, body weight & amp; lipid profile in early menopausal women
CONCLUSIONS: Continuous long-term therapy with DRSP 2 mg/E2 1 mg significantly lowered 24 h systolic and diastolic BPs and reduced the risk of cardiovascular disease in early menopausal women with stage 1 hypertension. Timely initiated menopausal hormone therapy can have beneficial effects on BP and can reduce the incidence of cardiovascular disease in menopausal women.PMID:35662091 | DOI:10.4103/ijmr.IJMR_478_20 (Source: The Indian Journal of Medical Research)
Source: The Indian Journal of Medical Research - June 6, 2022 Category: Biomedical Science Authors: Aleksandar Đogo Branko Do žić Svetlana Vujovi ć Dragana Srebro Ivan Do žić Source Type: research
Effects of continuous-combined oral drospirenone- estradiol on blood pressure, body weight & amp; lipid profile in early menopausal women
CONCLUSIONS: Continuous long-term therapy with DRSP 2 mg/E2 1 mg significantly lowered 24 h systolic and diastolic BPs and reduced the risk of cardiovascular disease in early menopausal women with stage 1 hypertension. Timely initiated menopausal hormone therapy can have beneficial effects on BP and can reduce the incidence of cardiovascular disease in menopausal women.PMID:35662091 | DOI:10.4103/ijmr.IJMR_478_20 (Source: Indian J Med Res)
Source: Indian J Med Res - June 6, 2022 Category: Research Authors: Aleksandar Đogo Branko Do žić Svetlana Vujovi ć Dragana Srebro Ivan Do žić Source Type: research
Effects of continuous-combined oral drospirenone- estradiol on blood pressure, body weight & amp; lipid profile in early menopausal women
CONCLUSIONS: Continuous long-term therapy with DRSP 2 mg/E2 1 mg significantly lowered 24 h systolic and diastolic BPs and reduced the risk of cardiovascular disease in early menopausal women with stage 1 hypertension. Timely initiated menopausal hormone therapy can have beneficial effects on BP and can reduce the incidence of cardiovascular disease in menopausal women.PMID:35662091 | DOI:10.4103/ijmr.IJMR_478_20 (Source: The Indian Journal of Medical Research)
Source: The Indian Journal of Medical Research - June 6, 2022 Category: Biomedical Science Authors: Aleksandar Đogo Branko Do žić Svetlana Vujovi ć Dragana Srebro Ivan Do žić Source Type: research
Effects of continuous-combined oral drospirenone- estradiol on blood pressure, body weight & amp; lipid profile in early menopausal women
CONCLUSIONS: Continuous long-term therapy with DRSP 2 mg/E2 1 mg significantly lowered 24 h systolic and diastolic BPs and reduced the risk of cardiovascular disease in early menopausal women with stage 1 hypertension. Timely initiated menopausal hormone therapy can have beneficial effects on BP and can reduce the incidence of cardiovascular disease in menopausal women.PMID:35662091 | DOI:10.4103/ijmr.IJMR_478_20 (Source: The Indian Journal of Medical Research)
Source: The Indian Journal of Medical Research - June 6, 2022 Category: Biomedical Science Authors: Aleksandar Đogo Branko Do žić Svetlana Vujovi ć Dragana Srebro Ivan Do žić Source Type: research
Effects of continuous-combined oral drospirenone- estradiol on blood pressure, body weight & amp; lipid profile in early menopausal women
CONCLUSIONS: Continuous long-term therapy with DRSP 2 mg/E2 1 mg significantly lowered 24 h systolic and diastolic BPs and reduced the risk of cardiovascular disease in early menopausal women with stage 1 hypertension. Timely initiated menopausal hormone therapy can have beneficial effects on BP and can reduce the incidence of cardiovascular disease in menopausal women.PMID:35662091 | DOI:10.4103/ijmr.IJMR_478_20 (Source: Indian J Med Res)
Source: Indian J Med Res - June 6, 2022 Category: Research Authors: Aleksandar Đogo Branko Do žić Svetlana Vujovi ć Dragana Srebro Ivan Do žić Source Type: research
Effects of continuous-combined oral drospirenone- estradiol on blood pressure, body weight & amp; lipid profile in early menopausal women
CONCLUSIONS: Continuous long-term therapy with DRSP 2 mg/E2 1 mg significantly lowered 24 h systolic and diastolic BPs and reduced the risk of cardiovascular disease in early menopausal women with stage 1 hypertension. Timely initiated menopausal hormone therapy can have beneficial effects on BP and can reduce the incidence of cardiovascular disease in menopausal women.PMID:35662091 | DOI:10.4103/ijmr.IJMR_478_20 (Source: The Indian Journal of Medical Research)
Source: The Indian Journal of Medical Research - June 6, 2022 Category: Biomedical Science Authors: Aleksandar Đogo Branko Do žić Svetlana Vujovi ć Dragana Srebro Ivan Do žić Source Type: research
Effects of continuous-combined oral drospirenone- estradiol on blood pressure, body weight & amp; lipid profile in early menopausal women
CONCLUSIONS: Continuous long-term therapy with DRSP 2 mg/E2 1 mg significantly lowered 24 h systolic and diastolic BPs and reduced the risk of cardiovascular disease in early menopausal women with stage 1 hypertension. Timely initiated menopausal hormone therapy can have beneficial effects on BP and can reduce the incidence of cardiovascular disease in menopausal women.PMID:35662091 | DOI:10.4103/ijmr.IJMR_478_20 (Source: Indian J Med Res)
Source: Indian J Med Res - June 6, 2022 Category: Research Authors: Aleksandar Đogo Branko Do žić Svetlana Vujovi ć Dragana Srebro Ivan Do žić Source Type: research
Effects of continuous-combined oral drospirenone- estradiol on blood pressure, body weight & amp; lipid profile in early menopausal women
CONCLUSIONS: Continuous long-term therapy with DRSP 2 mg/E2 1 mg significantly lowered 24 h systolic and diastolic BPs and reduced the risk of cardiovascular disease in early menopausal women with stage 1 hypertension. Timely initiated menopausal hormone therapy can have beneficial effects on BP and can reduce the incidence of cardiovascular disease in menopausal women.PMID:35662091 | DOI:10.4103/ijmr.IJMR_478_20 (Source: Indian J Med Res)
Source: Indian J Med Res - June 6, 2022 Category: Research Authors: Aleksandar Đogo Branko Do žić Svetlana Vujovi ć Dragana Srebro Ivan Do žić Source Type: research
Effects of continuous-combined oral drospirenone- estradiol on blood pressure, body weight & amp; lipid profile in early menopausal women
CONCLUSIONS: Continuous long-term therapy with DRSP 2 mg/E2 1 mg significantly lowered 24 h systolic and diastolic BPs and reduced the risk of cardiovascular disease in early menopausal women with stage 1 hypertension. Timely initiated menopausal hormone therapy can have beneficial effects on BP and can reduce the incidence of cardiovascular disease in menopausal women.PMID:35662091 | DOI:10.4103/ijmr.IJMR_478_20 (Source: The Indian Journal of Medical Research)
Source: The Indian Journal of Medical Research - June 6, 2022 Category: Biomedical Science Authors: Aleksandar Đogo Branko Do žić Svetlana Vujovi ć Dragana Srebro Ivan Do žić Source Type: research
Effects of continuous-combined oral drospirenone- estradiol on blood pressure, body weight & amp; lipid profile in early menopausal women
CONCLUSIONS: Continuous long-term therapy with DRSP 2 mg/E2 1 mg significantly lowered 24 h systolic and diastolic BPs and reduced the risk of cardiovascular disease in early menopausal women with stage 1 hypertension. Timely initiated menopausal hormone therapy can have beneficial effects on BP and can reduce the incidence of cardiovascular disease in menopausal women.PMID:35662091 | DOI:10.4103/ijmr.IJMR_478_20 (Source: Indian J Med Res)
Source: Indian J Med Res - June 6, 2022 Category: Research Authors: Aleksandar Đogo Branko Do žić Svetlana Vujovi ć Dragana Srebro Ivan Do žić Source Type: research
Effects of continuous-combined oral drospirenone- estradiol on blood pressure, body weight & amp; lipid profile in early menopausal women
CONCLUSIONS: Continuous long-term therapy with DRSP 2 mg/E2 1 mg significantly lowered 24 h systolic and diastolic BPs and reduced the risk of cardiovascular disease in early menopausal women with stage 1 hypertension. Timely initiated menopausal hormone therapy can have beneficial effects on BP and can reduce the incidence of cardiovascular disease in menopausal women.PMID:35662091 | DOI:10.4103/ijmr.IJMR_478_20 (Source: The Indian Journal of Medical Research)
Source: The Indian Journal of Medical Research - June 6, 2022 Category: Biomedical Science Authors: Aleksandar Đogo Branko Do žić Svetlana Vujovi ć Dragana Srebro Ivan Do žić Source Type: research
Effects of continuous-combined oral drospirenone- estradiol on blood pressure, body weight & amp; lipid profile in early menopausal women
CONCLUSIONS: Continuous long-term therapy with DRSP 2 mg/E2 1 mg significantly lowered 24 h systolic and diastolic BPs and reduced the risk of cardiovascular disease in early menopausal women with stage 1 hypertension. Timely initiated menopausal hormone therapy can have beneficial effects on BP and can reduce the incidence of cardiovascular disease in menopausal women.PMID:35662091 | DOI:10.4103/ijmr.IJMR_478_20 (Source: Indian J Med Res)
Source: Indian J Med Res - June 6, 2022 Category: Research Authors: Aleksandar Đogo Branko Do žić Svetlana Vujovi ć Dragana Srebro Ivan Do žić Source Type: research
Effects of continuous-combined oral drospirenone- estradiol on blood pressure, body weight & amp; lipid profile in early menopausal women
CONCLUSIONS: Continuous long-term therapy with DRSP 2 mg/E2 1 mg significantly lowered 24 h systolic and diastolic BPs and reduced the risk of cardiovascular disease in early menopausal women with stage 1 hypertension. Timely initiated menopausal hormone therapy can have beneficial effects on BP and can reduce the incidence of cardiovascular disease in menopausal women.PMID:35662091 | DOI:10.4103/ijmr.IJMR_478_20 (Source: Indian J Med Res)
Source: Indian J Med Res - June 6, 2022 Category: Research Authors: Aleksandar Đogo Branko Do žić Svetlana Vujovi ć Dragana Srebro Ivan Do žić Source Type: research
