Disease relevance of Therapeutic Equivalency

• Ciclopirox olamine lotion 1%: bioequivalence to ciclopirox olamine cream 1% and clinical efficacy in tinea pedis [1].
• Comparison of the efficacy and bioequivalence of two oral formulations of tiludronate in the treatment of Paget's disease of bone [2].
• In a multiple change-over study the bioequivalence of 3 thiamine preparations, used therapeutically as neurotropic agents for the treatment of polyneuropathies, was tested in a collective of 7 volunteers [3].
• The oral formulation of nicardipine investigated with a bioequivalence range > 70% compared to nicardipine immediate release tablets may represent an additional resource for treating elderly patients with concomitant cerebrovascular or coronary heart disease [4].
• A fast onset of effective, sustained pain relief was predicted for zolmitriptan ODT on the basis of its bioequivalence with the conventional tablet, which has been confirmed in three randomised, double-blind, placebo-controlled trials of zolmitriptan ODT in the acute treatment of migraine [5].

Psychiatry related information on Therapeutic Equivalency

• Two crossover bioequivalence trials of an enantioselectively enterohepatic recycled drug, carprofen, were conducted in dogs with the same racemic oral formulation to determine: (i) the influence of feeding patterns, and (ii) the effect of the analytical method (enantioselective vs non-enantioselective) on the statistical power of the trials [6].

High impact information on Therapeutic Equivalency

• Bioequivalence of levothyroxine preparations: industry sponsorship and academic freedom [7].
• OBJECTIVE: To establish the bioequivalence of a 500 mg film-coated tablet of saquinavir mesylate (FCT SQV) to the 200 mg hard-capsule saquinavir mesylate (HC SQV), both boosted with ritonavir and administered under fed conditions [8].
• Saquinavir 500 mg film-coated tablets demonstrate bioequivalence to saquinavir 200 mg hard capsules when boosted with twice-daily ritonavir in healthy volunteers [8].
• Tamoxifen dosage and bioequivalence: a correction [9].
• Confidence intervals for all three were within the no-effect or bioequivalence range of 0.80-1.25 for (R)-methadone [10].

Chemical compound and disease context of Therapeutic Equivalency

• Therefore, a bioequivalence study using a randomized crossover design (reference = without glycine, test = with glycine) in 12 healthy male volunteers (age 22 - 38 (median 26) years, body weight 64 - 83 (median 75) kg) was performed [11].
• Dose proportionality of stavudine in HIV seropositive asymptomatic subjects: application to bioequivalence assessment of various capsule formulations [12].
• A randomized, two-way, crossover, bioequivalence study was conducted in 26 fasting, healthy, male volunteers to compare two brands of citalopram 40 mg tablets, Citol (Abdi Ibrahim Ilaç San. ve Tic A.S., Istanbul, Turkey) as a test and Cipramil (H. Lundbeck A/S, Copenhagen, Denmark) as a reference product [13].
• Comparative open, randomized, cross-over bioequivalence study of two intravenous dexrazoxane formulations (Cardioxane and ICRF-187) in patients with advanced breast cancer, treated with 5-fluorouracil-doxorubicin-cyclophosphamide (FDC) [14].

Biological context of Therapeutic Equivalency

• Heart rates and adverse events were higher with felodipine, demonstrating lack of bioequivalence with nifedipine [15].
• The method was utilized in studies to determine the absolute bioavailability of sublingual doses of 2 mg of buprenorphine in 1 mL of 300 mL/L ethanol and the bioequivalence of sublingual 8-mg tablet and 300 mL/L ethanol solution formulations [16].
• BACKGROUND: The extension of biowaivers (drug product approval without a pharmacokinetic bioequivalence study) to drugs belonging to Class III of the Biopharmaceutics Classification System (BCS) is currently a subject of much discussion [17].
• AIM: To determine the pharmacokinetics and bioequivalence of a new liquid formulation of ursodeoxycholic acid (Ursofalk suspension) with a standard capsule (Ursofalk) in a randomized, unblinded, crossover designed study of 24 healthy adults [18].
• Lack of average bioequivalence for zidovudine was found for C(max) but is not expected to be clinically significant, because the total AUC values were similar between formulations [19].

Anatomical context of Therapeutic Equivalency

• In this review we discuss the various methods to evaluate therapeutic efficacy and bioequivalence of levothyroxine preparations in the treatment of thyroid disease [20].

Associations of Therapeutic Equivalency with chemical compounds

• Bioequivalence study of a new tablet formulation of triamterene and hydrochlorothiazide [21].
• A three-treatment, single-dose, crossover bioequivalence study was conducted in healthy volunteers to compare urinary drug recovery following administration of hydrochlorothiazide tablets, the currently marketed capsule formulation of triamterene and hydrochlorothiazide (Dyazide), and a new tablet preparation of these active ingredients (Maxzide) [21].
• Bioequivalence study of nabumetone: tablet versus suspension [22].
• Bronchoprovocation studies may be used for determination of bioequivalence of multisource albuterol MDI products [23].
• The vasoconstrictor assay is the method of choice to assess dermatologic corticosteroid products bioequivalence if dose-response is validated [24].

Gene context of Therapeutic Equivalency

• Bioequivalence revisited: influence of age and sex on CYP enzymes [25].
• High-dose omeprazole: use of a multiple-dose study design to assess bioequivalence and accuracy of CYP2C19 phenotyping [26].
• Based on the bioequivalence criteria, the Bayesian-estimated clearance for patients receiving etanercept alone (mean: 0.070 L/h) was comparable to that for patients receiving a combination of etanercept and methotrexate (mean = 0.066 L/h) [27].
• Simultaneous itraconazole bioequivalence assessment and CYP3A phenotyping in South American subjects [28].
• So it is possible that differences in TPMT activity may influence the bioequivalence of azathioprine products among individuals, especially those patients deficient in TPMT enzyme activity [29].

Analytical, diagnostic and therapeutic context of Therapeutic Equivalency

• BACKGROUND: With the expiration of the patent on albuterol metered-dose inhalers (MDIs) in 1989, methods to assess in vivo bioequivalence of generic formulations required investigation [23].
• Our objectives were to determine whether in vivo activity of selected CYP enzymes is affected by age or sex and to evaluate sex bioequivalence in a large sample size [25].
• This open-label, randomized, crossover study was conducted to demonstrate bioequivalence for telithromycin administered as crushed or whole tablets [30].
• Reversed-phase high-performance liquid chromatography of ketorolac and its application to bioequivalence studies in human serum [31].
• The assay was used in a randomized cross-over bioequivalence trial using an oral administration of 20 mg of timolol [32].

References