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https://www.readbyqxmd.com/read/28810949/analysis-of-non-pivotal-bioequivalence-studies-submitted-in-abbreviated-new-drug-submissions-for-delayed-release-drug-products
#1
Paramjeet Kaur, Xiaojian Jiang, Ethan Stier
The US FDA's rule on "Requirements for Submission of Bioequivalence Data" requiring submission of all bioequivalence (BE) studies conducted on the same formulation of the drug product submitted for approval was published in Federal Register in January 2009. With the publication of this rule, we evaluated the impact of data from non-pivotal BE studies in assessing BE and identified the reasons for failed in vivo BE studies for generic oral delayed-release (DR) drug products only. We searched the Agency databases from January 2009 toDecember 2016 to identify Abbreviated New Drug Applications (ANDAs) submitted for DR drug products containing non-pivotal BE studies...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28808905/a-pharmacokinetic-bioequivalence-study-comparing-pirfenidone-tablet-and-capsule-dosage-forms-in-healthy-adult-volunteers
#2
Lin Pan, Paula Belloni, Han Ting Ding, Jianshuang Wang, Christopher M Rubino, Wendy S Putnam
INTRODUCTION: Pirfenidone film-coated tablets were developed to offer an alternative to the marketed capsule formulation. This study assessed the bioequivalence of the tablet and capsule formulations under fed and fasted states. METHODS: A Phase I, open-label, randomized, four-treatment-period, four-sequence, crossover pharmacokinetics study (NCT02525484) was conducted. Each subject received an 801-mg single dose of pirfenidone as three 267-mg capsules or one 801-mg tablet under fasted and fed conditions...
August 14, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28800211/pharmacokinetics-and-bioequivalence-of-branded-and-generic-formulations-of-dofetilide-0-5-mg-capsules-after-single-dose-administration-in-healthy-subjects
#3
James T VanderLugt, Charles Bon, Dean Knuth, Rhonda Schreiber, Michael D Ruff
Class III antiarrhythmics are preferred therapy for managing atrial fibrillation/flutter. Dofetilide 0.5-mg capsules were US Food and Drug Administration (FDA) approved in 1999 to treat atrial fibrillation/flutter. Bioequivalence of generic dofetilide is important for treating arrhythmias because drug concentrations must be consistent to maintain normal sinus rhythm. Generic dofetilide 0.5-mg capsule pharmacokinetics were compared with branded product in 2 open-label, 2-way crossover, single-dose studies - 1 study each in fasted and fed healthy subjects...
August 11, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28800206/relative-bioavailability-of-fixed-dose-combinations-of-tamsulosin-and-dutasteride-results-from-2-randomized-trials-in-healthy-male-volunteers
#4
Olivia Burns, John Zhu, Michael J Manyak, Ramiya Ravindranath, Fariba Koosha, Nazneen Haque, Sally Chung
The relative bioavailabilities of dutasteride/tamsulosin hydrochloride 0.5 mg/0.2 mg fixed-dose combination (FDC) capsules compared with coadministered reference products (1 dutasteride 0.5-mg capsule [Avodart(®) ] + 1 tamsulosin hydrochloride 0.2-mg orally disintegrating tablet [Harnal D(®) ]) were investigated in 2 clinical trials under fasted and fed conditions (ClinicalTrials.gov NCT02184585 and NCT02509104). Both trials were open-label, randomized, single-dose, crossover studies in healthy male adults aged 18-65 years...
August 11, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28793958/pharmacokinetics-and-relative-bioavailability-of-a-generic-amisulpride-tablet-in-healthy-chinese-volunteers%C3%A2
#5
Si-Si Cao, Yan-Xia Ma, Ping-Fei Fang, Hua-Lin Cai, Yang Deng, Zhen-Yan Hou, Ying Chen, Miao Yan, Bi-Kui Zhang
OBJECTIVE: To assess and compare the pharmacokinetic properties and bioavailability of a newly developed formulation of amisulpride with those of a conventional formulation in healthy Chinese volunteers under fasting state. MATERIALS AND METHODS: A single-dose, two-sequence crossover study was designed. 20 healthy subjects (14 males and 6 females) were randomized into two groups. A single oral dose of amisulpride (200 mg) was given after an overnight fast of 12 hours...
August 10, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28793071/nonbioequivalent-prescription-drug-interchangeability-concerns-on-patient-safety-and-drug-market-dynamics-in-brazil
#6
Francisco José Roma Paumgartten, Ana Cecilia Amado Xavier de Oliveira
Since the enforcement of Generics Act (1999), three types of pharmaceutically equivalent products are marketed in Brazil: innovative reference (REF), "similar" (S) and generic (G) drugs. The S (brand name) and G (generic name) borrow from REF (brand name) clinical data on safety and efficacy and dosage regimen. G (but not S) is bioequivalent to and interchangeable with REF. Starting in 2003, Brazilian Sanitary Surveillance Agency (Anvisa) has required data on relative bioavailability tests (with REF) to approve (or renew registration of) S drugs...
August 2017: Ciência & Saúde Coletiva
https://www.readbyqxmd.com/read/28783867/absence-of-effect-of-intravaginal-miconazole-clindamycin-nonoxynol-9-and-tampons-on-the-pharmacokinetics-of-an-anastrozole-levonorgestrel-intravaginal-ring
#7
Rüdiger Nave, Stefan Klein, André Müller, Xinying Chang, Joachim Höchel
A study was performed to investigate the effect of an intravaginally administered antimycotic, an antibiotic, and a spermicide plus the co-usage of tampons on the pharmacokinetics (PK) of levonorgestrel (LNG) and anastrozole (ATZ) administered as an intravaginal ring (IVR) releasing 1050 μg ATZ per day and 40 μg LNG per day. In this parallel-group, randomized, open-label study, healthy premenopausal women received an IVR as the main treatment. Comedications were administered on 3 consecutive evenings during treatment with IVR on days 9-11 (group A, 400 mg miconazole; group B, 100 mg clindamycin; group C, 75 mg nonoxynol-9); tampon co-usage (group D) was performed on days 20-23...
August 7, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28774813/virtual-bioequivalence-for-achlorhydric-subjects-the-use-of-pbpk-modelling-to-assess-the-formulation-dependent-effect-of-achlorhydria
#8
Kosuke Doki, Adam S Darwich, Nikunjkumar Patel, Amin Rostami-Hodjegan
Majority of bioequivalence studies are conducted in healthy volunteers. It has been argued that bioequivalence may not necessarily hold true in relevant patient populations due to a variety of reasons which affect one formulation more than the other for instance in achlorhydric patients where elevated gastric pH may lead to differential effects on formulations which are pH-sensitive with respect to release or dissolution. We therefore examined achlorhydria-related disparity in bioequivalence of levothyroxine and nifedipine formulations using virtual bioequivalence within a physiologically-based pharmacokinetic (PBPK) modelling framework...
August 1, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28766500/a-bioequivalence-study-of-two-memantine-formulations-in-healthy-chinese-male-volunteers%C3%A2
#9
Ying Deng, Jialang Zhuang, Jinguo Wu Jiangying Chen, Liang Ding, Xueding Wang, Lihui Huang, Guixiong Zeng, Jie Chen, Zhongfu Ma, Xiao Chen, Guoping Zhong, Min Huang, Xianglan Zhao
OBJECTIVE: The aim of the current study is to evaluate the bioequivalence between the test and reference formulations of memantine in a single-dose, two-period and two-sequence crossover study with a 44-day washout interval. MATERIALS AND METHODS: A total of 20 healthy Chinese male volunteers were enrolled and completed the study, after oral administration of single doses of 10 mg test and reference formulations of memantine. The blood samples were collected at different time points and memantine concentrations were determined by a fully validated HPLC-MS/MS method...
August 2, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28761573/safety-efficacy-and-bioavailability-of-fixed-dose-combinations-in-type-2-diabetes-mellitus-a-systematic-updated-review
#10
REVIEW
Thangavel Mahalingam Vijayakumar, Jayasutha Jayram, Vishnu Meghana Cheekireddy, Dasari Himaja, Yalamanchili Dharma Teja, Damodharan Narayanasamy
PURPOSE: Type 2 diabetes mellitus (T2DM) is a multifactorial disease characterized by insulin resistance. As time progresses, monotherapy often does not provide effective glycemic control, generating the need for an add-on therapy. Hence, multiple oral hypoglycemic agents formulated as a single-dose form called fixed-dose combinations (FDCs) play an essential role in glycemic control. The purpose of this systematic review is to appraise the recently published evidence on the safety, efficacy, and bioavailability of FDCs...
2017: Current Therapeutic Research, Clinical and Experimental
https://www.readbyqxmd.com/read/28758694/comparison-of-caffeine-disposition-following-administration-by-oral-solution-energy-drink-and-inspired-powder-aeroshot-in-human-subjects
#11
S C Laizure, B Meibohm, K Nelson, F Chen, Z Hu, R B Parker
AIMS: To determine the disposition and effects of caffeine after administration using a new dosage form (AeroShot) that delivers caffeine by inspiration of a fine powder into the oral cavity and compare it to an equivalent dose of an oral solution (energy drink) as the reference standard. METHODS: Healthy human subjects (n=17) inspired a 100 mg caffeine dose using the AeroShot device or energy drink on separate study days. Heart rate, blood pressure, and subject assessments of effects were measured over an eight-hour period...
July 31, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28758027/australasian-society-for-hiv-viral-hepatitis-and-sexual-health-medicine-hiv-pre-exposure-prophylaxis-clinical-guidelines
#12
EDITORIAL
Edwina Wright, Andrew Grulich, Katy Roy, Mark Boyd, Vincent Cornelisse, Darren Russell, Darryl O'Donnell, Bill Whittaker, Levinia Crooks, Iryna Zablotska
Daily use of coformulated tenofovir and emtricitabine for HIV pre-exposure prophylaxis (PrEP) by populations at high risk of HIV infection is now recommended in guidelines from the United States, Europe and Australia and globally through the 2015 WHO guidelines. These 2017 Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine's (ASHM) PrEP Guidelines are an updated adaptation of the 2014 US Centers for Disease Control's PrEP guidelines and are designed to: •Support the prescription of PrEP using forms of coformulated tenofovir and emtricitabine that have been registered in Australia by the Therapeutic Goods Administration and other bioequivalent generic drugs that are available in Australia through self-importation, private prescription or Australian PrEP clinical trials•Assist clinicians in the evaluation of patients who are seeking PrEP•Assist clinicians in commencing and monitoring patients on PrEP including PrEP dosing schedules, management of side-effects and toxicity, use of PrEP in pregnancy and in chronic hepatitis B infection and how to cease PrEP Daily PrEP with co-formulated tenofovir and emtricitabine, used continuously or for shorter periods of time, is recommended in these guidelines as a key HIV-prevention option for men who have sex with men (MSM), transgender men and women, heterosexual men and women, and people who inject drugs (PWID) at substantial risk of HIV acquisition...
July 1, 2017: Journal of Virus Eradication
https://www.readbyqxmd.com/read/28756607/a-randomized-open-label-two-way-crossover-single-dose-bioequivalence-study-of-temozolomide-200%C3%A2-mg-m-2-dralitem-%C3%A2-vs-temodal-%C3%A2-capsules-in-patients-with-primary-tumors-of-the-central-nervous-system-under-fasting-conditions
#13
Alejandro Muggeri, Miguel Vago, Sebastián Pérez, Marcelo Rubio, Cecilia González, Cristian Magariños, Mónica Rosenberg, Fernando Costa, Santiago Pérez-Lloret
BACKGROUND: Temozolomide is an antineoplastic agent of proven efficacy against high-grade gliomas. PURPOSE: The objective of this crossover, single-dose, bioequivalence study was to compare the rate and extent of absorption of oral temozolomide after administration of the study product (Dralitem(®), Monte Verde Sociedad Anónima) and the reference product (Temodal(®), originator product manufactured by Schering Plough Laboratories) in patients with primary central nervous system (CNS) tumors under fasting conditions...
July 29, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28756067/pharmacokinetics-dose-proportionality-and-bioavailability-of-bazedoxifene-in-healthy-postmenopausal-women
#14
William McKeand
PURPOSE: Bazedoxifene is a selective estrogen receptor modulator that has estrogen agonist effects on bone and lipid metabolism while having neutral or estrogen antagonist effects on the breast and endometrium. The present report describes findings from 3 Phase I clinical studies that evaluated the single-dose pharmacokinetics (study 1; n = 84), multiple-dose pharmacokinetics (study 2; n = 23), and absolute bioavailability (study 3; n = 18) of bazedoxifene. METHODS: All 3 studies enrolled healthy postmenopausal women who were either naturally postmenopausal or had undergone bilateral oophorectomy at least 6 months before the start of the study...
July 26, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28753469/nk1-receptor-antagonists-for-depression-why-a-validated-concept-was-abandoned
#15
REVIEW
Nadia M J Rupniak, Mark S Kramer
BACKGROUND: NK1 receptor antagonists were abandoned despite antidepressant efficacy in five randomized clinical trials. The loss of confidence may be attributed to the failure of a Phase III clinical program with the NK1 receptor antagonist aprepitant in Major Depression. This review examines how PET receptor occupancy was used to select doses for aprepitant and that these may not have achieved adequate exposure. METHODS: PubMed, Google Scholar, and FDA databases were searched for articles concerning NK1 receptor antagonists, human PET receptor occupancy and clinical trials in Major Depression...
July 20, 2017: Journal of Affective Disorders
https://www.readbyqxmd.com/read/28744102/bioequivalence-of-generic-alendronate-sodium-tablets-70-mg-to-fosamax-%C3%A2-tablets-70-mg-in-fasting-healthy-volunteers-a-randomized-open-label-three-way-reference-replicated-crossover-study
#16
Yifan Zhang, Xiaoyan Chen, Yunbiao Tang, Youming Lu, Lixia Guo, Dafang Zhong
PURPOSE: The aim of this study was to evaluate the bioequivalence of a generic product 70 mg alendronate sodium tablets with the reference product Fosamax(®) 70 mg tablet. MATERIALS AND METHODS: A single-center, open-label, randomized, three-period, three-sequence, reference-replicated crossover study was performed in 36 healthy Chinese male volunteers under fasting conditions. In each study period, the volunteers received a single oral dose of the generic or reference product (70 mg)...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28737409/low-buffer-capacity-and-alternating-motility-along-the-human-gastrointestinal-tract-implications-for-in-vivo-dissolution-and-absorption-of-ionizable-drugs
#17
Bart Hens, Yasuhiro Tsume, Marival Bermejo, Paulo Paixao, Mark J Koenigsknecht, Jason R Baker, William L Hasler, Robert Lionberger, Jianghong Fan, Joseph Dickens, Kerby Shedden, Bo Wen, Jeffrey Wysocki, Raimar Loebenberg, Allen Lee, Ann Frances, Greg Amidon, Alex Yu, Gail Benninghoff, Niloufar Salehi, Arjang Talattof, Duxin Sun, Gordon L Amidon
In this study, we determined the pH and buffer capacity of human gastrointestinal (GI) fluids (aspirated from the stomach, duodenum, proximal jejunum, and mid/distal jejunum) as a function of time, from 37 healthy subjects after oral administration of an 800 mg immediate-release tablet of ibuprofen (reference listed drug; RLD) under typical prescribed bioequivalence (BE) study protocol conditions in both fasted and fed states (simulated by ingestion of a liquid meal). Simultaneously, motility was continuously monitored using water-perfused manometry...
August 4, 2017: Molecular Pharmaceutics
https://www.readbyqxmd.com/read/28737128/bioequivalence-of-two-oseltamivir-formulations-in-healthy-chinese-volunteers%C3%A2
#18
Yun-Lei Yun, Shou-Hong Gao, Yan Wen, Zhi-Peng Wang, Hai-Jun Miao, Wan-Sheng Chen
BACKGROUND: The aim of this study was to compare the bioavailability of a new generic formulation of oseltamivir 75-mg capsule (test) and a branded formulation Tamiflu® (reference) to meet regulatory criteria for marketing the test product in healthy Chinese male volunteers. METHODS: This single-dose, randomized-sequence, open-label, two-period crossover study was conducted in fasted healthy Chinese male volunteers, who first received a single oral dose of the test or reference formulation with a 7-day washout period, and then the alternative formulation...
July 24, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28733752/generic-immunosuppressants
#19
Mara Medeiros, Julia Lumini, Noah Stern, Gilberto Castañeda-Hernández, Guido Filler
Immunosuppressive drugs for solid organ transplantation are critical dose drugs with a narrow therapeutic index. Many of the most commonly used innovator drugs are off patent and have been replicated by generic counterparts, often at substantial cost-savings to the patient. However, serious adverse events caused by the transition from innovator to generic medications, specifically in pediatric solid organ transplant recipients, have questioned these autosubstitutions. The purpose of this review is to summarize the criteria set forth by the regulatory bodies, and to examine how major immunosuppressive drugs conform to these recommendations...
July 21, 2017: Pediatric Nephrology: Journal of the International Pediatric Nephrology Association
https://www.readbyqxmd.com/read/28725140/formulation-and-pharmacokinetics-of-multi-layered-matrix-tablets-biphasic-delivery-of-diclofenac
#20
Ehab Mostafa Elzayat, Ali Abdelzaher Abdel-Rahman, Sayed Mohamed Ahmed, Fars Kaed Alanazi, Walid Abdulazim Habib, Hisham Suliman Abou-Auda, Adel Sakr
The rapid availability of the drug at the site of action followed by maintaining its effect for a long period of time is of great clinical importance. Thus, the purpose of the present study was to prepare and evaluate multi-layered matrix tablets of diclofenac using Eudragit RL/RS blend to achieve both immediate and sustained therapeutic effects. Diclofenac potassium (25 mg) was incorporated in an outer immediate release layer to provide immediate pain relief whereas diclofenac sodium (75 mg) was incorporated in the inner core to provide extended drug release...
July 2017: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
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