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Therapeutic Equivalency (0):
Recent article
Therapeutic Equivalency
Abstract
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Abstract
The geometric means, Cmax, of the reference and the test formulations were 696.42 and 734.06 ng/ml. The mean values of the AUC0-t and AUC0-inf of the test formulation were 2,073.03 and 2,237.37 ng × h/ml, while those of the reference formulation were 1,950.26 and 2,078.06 ng × h/ml. The geometric...
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PMID: 21781653
PDF is available here.
PDF is available here.
Abstract
Different statistical approaches for making data comparisons are discussed and may be successfully applied during reanalysis of samples from a bioequivalence study. Results of the evaluations may differ in accordance with the statistical procedure being applied, thus a definitive conclusion requires...
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PMID: 21679029
PDF is available here.
PDF is available here.
Abstract
Abstract
The 90% confidence intervals for Test/Reference ratios of the pharmacokinetic parameters (Cmax, AUC0-t and AUC0-∞) of both risperidone and its active metabolite (9-hydroxyrisperidone) fell within the acceptable bioequivalence range (80 - 125%) according to ASEAN guideline. Conclusion: The two risp...
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PMID: 21612749
PDF is available here.
PDF is available here.
New England Journal of Medicine (364)21 2011
Abstract
New England Journal of Medicine (364)21 2011
Abstract
Abstract
I drugs, IND salts could be considered for possible waivers of bioequivalence....
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PMID: 21453261
PDF is available here.
PDF is available here.
Abstract
A comparative pharmacokinetic study of three enrofloxacin injectable solutions was carried out in six healthy Barky rams after intramuscular injection according to a single dose, randomized, crossover experimental design. The three formulations were enrofloxacin 10% (Baytril(®)), enrofloxacin 10% pl...
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PMID: 21457136
PDF is available here.
PDF is available here.
Ceska a Slovenska farmacie : casopis Ceske farmaceuticke spolecnosti a Slovenske farmaceuticke spolecnosti (60)2 2011
Abstract
When dispensing the medication, the dispensing chemist should inform the patient about the possible alternatives to the medicament dispensed and, with his consent, he can replace it with another preparation of identical properties (a generic drug, a bioequivalent preparation) in case it is not forbid...
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PMID: 21650009
PDF is available here.
PDF is available here.
Abstract
To study the pharmacokinetics and bioavailability of ginkgolides sustained-release tablet and conventional tablet in Beagle dogs.
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PMID: 21809574
PDF is available here.
PDF is available here.
The Lancet (377)9772 2011
Abstract
We assessed whether early fi rst-trimester medical abortion provided by midlevel providers (government-trained, certified nurses and auxiliary nurse midwives) was as safe and effective as that provided by doctors in Nepal.
This multicentre randomised controlled equivalence trial was...
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PMID: 21458058
PDF is available here.
PDF is available here.
Abstract
Human chorionic gonadotropin (hCG) is a therapeutic protein used for ovulation induction in women with infertility. Dong-A Pharm. Co. has developed recombinant hCG (rhCG) [product code DA-3803] produced in Chinese hamster ovary cells and evaluated its biologic properties, such as biologic potency, ef...
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PMID: 21443274
PDF is available here.
PDF is available here.
Abstract
The aim of this article is to focus on compounded bioidentical hormone (BH) formulations for menopausal symptoms and to discuss the impact of these on women's choice of treatment. The practice of compounding BHs for individualized treatment of women with menopausal symptoms has developed in the USA....
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PMID: 21427420
PDF is available here.
PDF is available here.
Abstract
To determine the ability of a community pharmacist to reduce the annual drug expenditures for Medicare Part D enrollees.
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PMID: 21402518
PDF is available here.
PDF is available here.
Abstract
Liquid chromatography-electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS) was used for a quantitative estimation of entecavir (EV) in human plasma using lamivudine (LM) as internal standard (IS). The method herein described is simple, sensitive, and specific. Chromatograp...
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PMID: 21397572
PDF is available here.
PDF is available here.
Abstract
To compare the pharmacokinetic (PK) profiles and bioequivalence of the extended-release (ER) and immediate-release (IR) formulations of dexibuprofen (DI) in healthy Chinese volunteers after single dose and multiple doses.
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PMID: 21329626
PDF is available here.
PDF is available here.
Abstract
To identify social predictors for enrollment failures of healthy volunteers (hv) in bioequivalence trials.
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PMID: 21329625
PDF is available here.
PDF is available here.
Abstract
Evaluation of the long-term benefits of combined pharmacological and psychotherapeutic depression treatment and the differential impact of early childhood trauma.
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PMID: 21231926
PDF is available here.
PDF is available here.
Abstract
Meloxicam is a cyclooxygenase-2, preferential inhibitor non-steroidal anti-inflammatory drug (NSAID) and belongs to an enolic acid (oxicam) class used for the treatment of osteoarthritis and rheumatoid arthritis. The purpose of this single dose randomized cross-over study was to assess bioequivalence...
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PMID: 21485709
PDF is available here.
PDF is available here.
Abstract
Evaluation of in vitro-in vivo correlation (IVIVC) plays important role in securing therapeutic effect if a dosage form undergoes technological modifications. Similarity (closeness) of dissolution profiles of the original and modified dosage forms has been traditionally considered to be sufficient fo...
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PMID: 21648197
PDF is available here.
PDF is available here.
Abstract
Abstract
The 6th European Antibody Congress (EAC), organized by Terrapinn Ltd., was held in Geneva, Switzerland, which was also the location of the 4th and 5th EAC. As was the case in 2008 and 2009, the EAC was again the largest antibody congress held in Europe, drawing nearly 250 delegates i...
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PMID: 21441785
PDF is available here.
PDF is available here.
Abstract
The 21st Annual Antibody Engineering and 8th Annual Antibody Therapeutics international conferences, and the 2010 Annual Meeting of The Antibody Society, organized by IBC Life Sciences with contributions from The Antibody Society and two Scientific Advisory Boards, were held December...
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PMID: 21304271
PDF is available here.
PDF is available here.
Abstract
In this study, an attempt was made to describe and validate liquid chromatography-electrospray ionization tandem mass spectrometry as a fast, sensitive and reproducible method for determining finasteride in human plasma. Finasteride and internal standard (pantoprazole) were extracted by liquid-liquid...
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PMID: 21302041
PDF is available here.
PDF is available here.
Abstract
A highly sensitive and rapid method for the analysis of pantoprazole in human plasma using liquid chromatography coupled to tandem electrospray ionization mass spectrometry was developed. The procedure involves a simple protein precipitation method with methyl alcohol and separation by RP-HPLC. Detec...
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PMID: 21302042
PDF is available here.
PDF is available here.
Seton Hall law review (41)2 2011
Abstract
Seton Hall law review (41)2 2011
Abstract
Abstract
An open randomized crossover test on 18 healthy volunteers was used to study the pharmacokinetics of anvifen (acting substance, aminophenylbutyric acid) manufactured in capsules at the Joint-Stock Company "Antiviral" (Russia). The test was performed after single peroral administration in comparison w...
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PMID: 21809698
PDF is available here.
PDF is available here.
Seton Hall law review (41)2 2011
Abstract
This book of the Seton Hall Law Review presents the contributions to Follow-On Biologics: Implementation Challenges and Opportunities, a one-day roundtable event hosted by Seton Hall University School of Law in the fall of 2010. The roundtable fostered an international dialogue regarding the future o...
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PMID: 21739728
PDF is available here.
PDF is available here.
Arzneimittel-Forschung (61)4 2011
Abstract
The market of generic drugs has been greatly developing during the last 15 years in various European Union (EU) member states, mainly in the Mediterranean area, including non-EU countries, i.e., in the Middle East. This has required a more detailed support from EMA (European Medicines Agency) as guid...
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PMID: 21650079
PDF is available here.
PDF is available here.
Arzneimittel-Forschung (61)4 2011
Abstract
The present study was performed to compare the bioavailability of two perindopril erbumine (CAS 107133-36-8) 4 mg tablet formulations (test formulation and reference formulation). This study was a randomized, single-blind, two-period, two-sequence cross-over study which included 20 healthy adult male...
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PMID: 21650082
PDF is available here.
PDF is available here.
Arzneimittel-Forschung (61)7 2011
Abstract
A simple, sensitive and modified method was developed for determination of low dihydrocodeine (CAS 125-28-0) concentrations in human plasma by high performance-liquid chromatography (HPLC) with diode array detector. Measurement was performed on a Zorbax XDB-C18 analytical column toge...
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PMID: 21899209
PDF is available here.
PDF is available here.
Arzneimittel-Forschung (61)2 2011
Abstract
A sensitive and specific liquid chromatography-electrospray ionization mass spectrometry (LC-ESI-MS) method was developed and validated for the identification and quantification of voriconazole (VRC, CAS 137234-62-9) in human plasma. Following liquid-liquid extraction, VRC and lorata...
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PMID: 21428249
PDF is available here.
PDF is available here.
Arzneimittel-Forschung (61)2 2011
Abstract
Two bioequivalence studies were carried out in healthy volunteers in order to compare the rate and extent of absorption of two dosage forms (film-coated tablet and orodispersible tablet) of oral olanzapine (CAS 132539-06-1) 10 mg test formulations and the respective brand formulation...
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PMID: 21428240
PDF is available here.
PDF is available here.
Arzneimittel-Forschung (61)2 2011
Abstract
A randomized, two-treatment and two-way crossover study on twelve healthy Indian male subjects was conducted to assess the bioequivalence of two tablet formulations containing 20 mg of rimonabant (CAS 158681-13-1). Both of the formulations were administered orally as a single dose wi...
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PMID: 21428241
PDF is available here.
PDF is available here.
Arzneimittel-Forschung (61)3 2011
Abstract
The aim of the present study was to determine the concentrations of nitroglycerin (glyceryl trinitrate, GTN, CAS 55-63-0) and its two main stable metabolites; 1,2-dinitroglycerin (1,2-glyceryl dinitrate, GDN, CAS 621-65-8) and 1,3-dinitroglycerin (1,3-GDN, CAS 623-87-0) in human plasma using a capill...
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PMID: 21528637
PDF is available here.
PDF is available here.
Arzneimittel-Forschung (61)3 2011
Abstract
Eplerenone (CAS 107724-20-9) prevents the binding of aldosterone, a key hormone in the renin-angiotensin-aldosterone-system (RAAS), which is involved in the regulation of blood pressure and the pathophysiology of cardiovascular disease and is indicated, in addition to standard therapy including beta-...
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PMID: 21528639
PDF is available here.
PDF is available here.
Arzneimittel-Forschung (61)3 2011
Abstract
The pharmacokinetics and relative bioavailability/bioequivalence of two formulations of mosapride citrate (CAS 112885-42-4) were assessed in this study. The study was conducted in 20 healthy Chinese male volunteers according to an open, randomized, single-blind, 2-way crossover study design with a wa...
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PMID: 21528641
PDF is available here.
PDF is available here.
Abstract
Tamsulosin, an alpha1 adrenoceptor blocking agent, exhibits selectivity for alpha1 receptors in human prostate. Blockade of these adrenoceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of benign pro...
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PMID: 21084043
PDF is available here.
PDF is available here.
Revue de l'infirmiere ()165 2010
Abstract
Abstract
In 2005, the World Health Organization (WHO) proposed that provided an active pharmaceutical ingredient could meet certain criteria, bioequivalence could be evaluated with a set of laboratory tests, obviating the need for expensive and time-consuming pharmacokinetic studies in humans. The aim of this...
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PMID: 20928870
PDF is available here.
PDF is available here.
Abstract
In a previous study it has been demonstrated that a dissolution/permeation (D/P) system can discriminate between different immediate release fenofibrate formulations. The fractions permeated were correlated with fenofibrate's in vivo exposure in rats following p.o. administration. In the present stu...
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PMID: 21105572
PDF is available here.
PDF is available here.
Abstract
We performed a second study, Study B. This study incorporated injection technique training, a defined injection site, and a larger sample size to accommodate variability. It also included a third formulation, creating a 3-period crossover design to assess the BE of 2.5, 5, and 10 mg/mL. Study B resu...
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PMID: 20708421
PDF is available here.
PDF is available here.
Anesthesiology (113)4 2010
Abstract
Abstract
Chemotherapy induced nausea and vomiting (CINV) is a common complication in the treatment of patients with cancer. The introduction of the first in class neurokinin-1 receptor antagonist aprepitant provided additive control on CINV in combination to existing antiemetics. Due to formulation issues, ap...
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PMID: 20795794
PDF is available here.
PDF is available here.
Revista de Neurologia (51)6 2010
Abstract
Epilepsy is a condition characterized by signs and symptoms of neurological disorder. Lamotrigine has been widely used, mainly due to their greater tolerability and lower rate of drug interactions with other antiepileptic drugs however the newest antiepileptic drugs have high cost to patient. In Bra...
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PMID: 20839169
PDF is available here.
PDF is available here.
Abstract
To determine the short-term antidepressant efficacy and tolerability of duloxetine and venlafaxine vs. each other, placebo, selective serotonin reuptake inhibitors (SSRIs), and tri- and tetracyclic antidepressants (TCAs) in adults with major depression.
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PMID: 20831742
PDF is available here.
PDF is available here.
Abstract
An efficient HPLC method for the determination of atazanavir in human plasma has been developed and validated. A relatively simple mobile phase consisting of acetonitrile-ammonium formate buffer (pH 3; 10 mM) (45:55, v/v) was pumped at a low flow rate of 0.3 ml/min through a reverse phase Phenomenex...
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PMID: 20395105
PDF is available here.
PDF is available here.
Abstract
The limit of quantification for escitalopram was 0.2 ng x ml(-1). The geometric mean with corresponding 90% confidence interval (CI) for Test/Reference percent ratios were 97.35% (90% CI = 90.28-104.96%) for C(max), 99.60% (90% CI = 92.93-106.74%) for AUC(last) and 99.92% (90% CI = 93.34-106.97%) fo...
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PMID: 20650049
PDF is available here.
PDF is available here.
Abstract
We found low percentages of agreement between the generic and disease-specific questionnaires to identify the same food allergic patients with the best or worst HRQL. Only patients with the best disease-specific HRQL also tended to have the best generic HRQL. Finally, the explained variance in HRQL...
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PMID: 20121759
PDF is available here.
PDF is available here.
Abstract
Abstract
Substituting generic formulations of the same chemical agent is a common practice in German health care on the basis of so called rebate contracts. The substitution of a medication may affect the patients' adherence or result in adverse events. While adverse events which may be caused by the pharmac...
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PMID: 20662309
PDF is available here.
PDF is available here.
Abstract
MMW Fortschritte der Medizin (152)22 2010
Abstract
Poultry Science (89)6 2010
Abstract
Male White Pekin ducks at 7 d posthatch were used in a 10-d experiment to determine the equivalency value of an Escherichia coli phytase (Phyzyme XP) in corn-soybean meal-based mash diets. Two hundred fifty-six ducks were grouped by weight into 8 blocks of 8 cages with 4 ducks per cage. The 8 diets...
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PMID: 20460667
PDF is available here.
PDF is available here.
Abstract
We found that the absorption rates of the formulations were similar after aerosolization and deposition in a multistage liquid impinger, which simulates more realistically the detachment of the drug crystals from the carrier lactose and their aerodynamic particle size-dependent deposition in the res...
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PMID: 20073555
PDF is available here.
PDF is available here.
Abstract
A rapid and highly sensitive method for the determination of alverine (ALV) and its metabolite, para hydroxy alverine (PHA), in human plasma using LC-MS/MS in positive ion electrospray ionization (ESI) in multiple reactions monitoring (MRM) mode was developed and validated. The proce...
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PMID: 20564607
PDF is available here.
PDF is available here.
Abstract
Due to the fact that in bioequivalence studies the rate of absorption of the new product is unknown, chiral bioanalytical methods should be employed for chiral drugs, such as ibuprofen, whose enantiomers exhibit different pharmacodynamic characteristics and whose enantiomer concentration ratio might...
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PMID: 20195587
PDF is available here.
PDF is available here.