Volume 54, No. 1/2016(January)
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Original
The association between urbanization and rheumatoid arthritis in Taiwan
Yi-Chun Chiang, Yu-Hsuan Yen, Wei-Chiao Chang, Kuei-Ju Cheng, Wei-Pin Chang, and Hsiang-Yin Chen
Price
42.00 $
Page No. 1
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 1/2016 (1-10)
The association between urbanization and rheumatoid arthritis in Taiwan
Yi-Chun Chiang1,2, Yu-Hsuan Yen1,2, Wei-Chiao Chang1,2, Kuei-Ju Cheng1,2, Wei-Pin Chang3, and Hsiang-Yin Chen1
1School of Pharmacy, 2Department of Pharmacy, Wan Fang Hospital, Taipei Medical University, Taipei, and 3Department of Healthcare Management, Yuanpei University, Hsinchu, Taiwan
Objectives: To investigate the association between rheumatoid arthritis (RA) and urbanization and compare the medication selection for RA patients in urban vs. rural areas. Methods: RA patients were identified among 1,000,000 random individuals from a 23-million-person nationwide health insurance database, and controls were matched at a 1 : 10 ratio. Taiwan’s 359 townships were grouped into 7 urbanization levels. Geographic region and monthly income were also analyzed. Medication use in the most urbanized and less-urbanized areas were also compared. Results: Rural dwellers had lower odds of having an RA diagnosis. The odds ratio (OR) for level 5 area residents of having an RA diagnosis was 0.62 (95% confidence interval (CI) 0.46 – 0.85; p = 0.002), and they were both 0.76 for level 6 – 7 area residents (95% CI, 0.61 – 0.95 for level 6; p = 0.017 and 0.60 – 0.96 for level 7; p = 0.021) compared to level 1 (the most urban dwellers). The ORs of having a new RA diagnosis were 0.57 (95% CI 0.41 – 0.79, p = 0.001) in eastern Taiwan and 0.33 (95% CI 0.15 – 0.69, p = 0.004) on offshore islands compared to northern Taiwan. No association was found between monthly income and RA. Urban-dwelling RA patients used more tumor necrosis factor-α antagonists (level 1 urbanization; n = 24; 2.3%) than RA patients in less-urbanized areas (level 2 – 7 urbanization n = 30; 1.3%; p = 0.038). Conclusion: Results of this study suggested that an RA diagnosis and treatment are associated with urbanization.Correspondence to:
Hsiang-Yin Chen, MS, PharmD
School of Pharmacy, Taipei Medical University
250 Wu-Hsing Street, Taipei 110, Taiwan
or
Wei-Pin Chang, PhD
Department of Healthcare Management
Yuanpei University
306 Yuanpei Street, Hsinchu 300, Taiwan
Email: [email protected] or [email protected]
Original
Efficient strategy for obtaining reliable pharmacokinetic parameters in population compartmental approaches
Junhee Lee, Dongwoo Kang, Euitae Kim, and Bo-Hyung Kim
Price
42.00 $
Page No. 11
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 1/2016 (11-18)
Efficient strategy for obtaining reliable pharmacokinetic parameters in population compartmental approaches
Junhee Lee1, Dongwoo Kang2, Euitae Kim3, and Bo-Hyung Kim4
1Department of Neuropsychiatry, Seoul National University Hospital, Seoul, Republic of Korea, 2Translational Medicine and Clinical Pharmacology, Daiichi Sankyo Pharma Development, Edison, NJ, USA, 3Department of Neuropsychiatry, Seoul National University Bundang Hospital, Gyeonggi-do, and 4Department of Clinical Pharmacology and Therapeutics, Kyung Hee University College of Medicine and Hospital, Seoul, Republic of Korea
Objective: This study aimed to suggest efficient strategies for obtaining reliable pharmacokinetic (PK) parameters in population compartmental approach (PCA) a early-phase or resource-limited clinical trials with limited data. Methods: This study employed plasma concentration of olanzapine, an antipsychotic drug, from a bioequivalence study. To assess bias and precision of PK parameters that were estimated from limited data, this study utilized simulations with the generation of small-size datasets (SSD) and minimal-sampling datasets (MSD) that consisted of limited volunteers and PK samplings per volunteer, respectively. Results: Clearance (CL) estimates were the most robust, volume of the central (Vc) and peripheral compartment (Vp) were moderately affected, and absorption rate constant (Ka) and intercompartmental clearance (Q) were very sensitive with limited dataset. MSD had more impact on the bias and precision of PK parameter estimation than SSD. Conclusions: Performance of PK parameter estimation evaluated by bias and precision from simulation datasets was better in SSD than MSD. This finding implies that collecting more PK samplings is a more efficient strategy than recruiting more volunteers in order to obtain informative results in performing PCA.Correspondence to:
Euitae Kim, MD, PhD
Department of Neuropsychiatry
Seoul National University Bundang Hospital
82 Gumi-ro173 Beon-gil, Bundang-gu,
Seongnamsi, Gyeonggi-do, 463-707, Republic of Korea
or
Bo-Hyung Kim, MD, PhD
Department of Clinical Pharmacology and Therapeutics
Kyung Hee University College of Medicine and Hospital
23, Kyungheedae-ro, Dongdaemun-gu,
Seoul 130-872, Republic of Korea
Email: [email protected] or [email protected]
Original
Effects of a novel finasteride 0.25% topical solution on scalp and serum dihydrotestosterone in healthy men with androgenetic alopecia
Maurizio Caserini, Milko Radicioni, Chiara Leuratti, Emanuela Terragni, Matilde Iorizzo, and Renata Palmieri
Price
42.00 $
Page No. 19
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 1/2016 (19-27)
Effects of a novel finasteride 0.25% topical solution on scalp and serum dihydrotestosterone in healthy men with androgenetic alopecia
Maurizio Caserini1, Milko Radicioni2, Chiara Leuratti2, Emanuela Terragni2, Matilde Iorizzo3, and Renata Palmieri1
1Polichem S.A., Lugano-Pazzallo, 2CROSS Research S.A., Phase I Unit, Arzo, and 3Private Practice in Dermatology, Bellinzona, Switzerland
Objective: The effects on scalp and serum dihydrotestosterone (DHT) of different doses of a novel topical solution of 0.25% finasteride (P-3074), a type 2 5α-reductase, were investigated in men with androgenetic alopecia. Methods: Two randomized, parallel-group studies were conducted. Study I: 18 men received 1 mL (2.275 mg) P-3074, applied to the scalp once a day (o.d.) or twice a day (b.i.d), or 1 mg oral tablet o.d. for 1 week. Study II: 32 men received P-3074 at the dose of 100 (0.2275 mg), 200 (0.455 mg), 300 (0.6285 mg), or 400 (0.91 mg) μL or the vehicle o.d. for 1 week. Scalp and serum DHT and serum testosterone were evaluated at baseline and treatment end. Results: Change from baseline in scalp DHT was –70% for P-3074 o.d. and approx. –50% for P-3074 b.i.d. and the tablet. Serum DHT decreased by 60 – 70%. The doses of 100 and 200 μL P-3074 resulted in a –47/–52% scalp DHT reduction, similar to the 300 and 400 μL doses (i.e., –37/–54%). A –5.6% inhibition was observed for the vehicle. Serum DHT was reduced by only –24/–26% with 100 and 200 μL P-3074 and by –44/–48% with 300 and 400 μL P-3074. No relevant changes occurred for serum testosterone. Conclusions: The novel finasteride 0.25% solution applied o.d. at the doses of 100 and 200 μL results in an appropriate inhibition of scalp DHT potentially minimizing the untoward sexual side-effects linked to a systemic DHT reduction.Correspondence to:
Renata Palmieri
Polichem S.A.
Via Senago 42D
CH-6912, Lugano-Pazzallo, Switzerland
Email: [email protected]
Original
Patient response to insurer-led intervention for medication adherence – a pilot study based on claims data in Korea
Hyun Soon Sohn, Sunmee Jang, Ju-Yeun Lee, and Euna Han
Price
42.00 $
Page No. 28
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 1/2016 (28-35)
Patient response to insurer-led intervention for medication adherence – a pilot study based on claims data in Korea
Hyun Soon Sohn1, Sunmee Jang2, Ju-Yeun Lee3, and Euna Han4
1Graduate School of Clinical Pharmacy, CHA University, Gyeonggi-do, 2College of Pharmacy, Gachon University, Incheon, 3College of Pharmacy, Hanyang University, Ansan, Gyeonggi-do, and 4College of Pharmacy, Yonsei Institute of Pharmaceutical Sciences, Yonsei University, Incheon, South Korea
Objective: This study was designed to investigate patient responses to a medication counseling intervention program piloted by the National Health Insurance Service (NHIS), the national health insurer in Korea, to improve medication management in patients with hypertension, hyperlipidemia, or diabetes. Methods and materials: Interventions were conducted from July to September 2013 through direct mailing followed by two telephone-initiated counseling sessions for the medication discontinuation group (< 80% medication possession ratio (MPR) and ≥ 2 months of discontinuation) and the medication over-possession group (≥ 150% MPR). The telephone intervention was applied through two models: model 1 (counseling by NHIS staff only) and model 2 (counseling by NHIS staff with contract-based working pharmacists in community pharmacies). Multivariate logistic regression analysis was performed to identify factors affecting favorable responses of patients to the telephone-initiated intervention. Patient responses to the telephone-initiated intervention were evaluated by a counselor. Results: In all, 891 patients were counseled via telephone. Patient responses to the telephone-initiated intervention were favorable in 57.6%, neutral in 17.4% and not favorable in 24.9% overall. Counseling by NHIS staff together with pharmacists (model 2) produced more favorable responses from patients than counseling by NHIS staff alone (model 1) (OR 2.73, 95% CI 1.97 – 3.77). Conclusion: Our findings of favorable responses to interventions support a personalized approach by the NHIS to improve patient behavior for medication adherence.Correspondence to:
Euna Han, PhD, Associate Professor
College of Pharmacy & Yonsei Institute of
Pharmaceutical Research, Yonsei University
162-1 Songdo-Dong, Yeonsu-Gu, Incheon, South Korea
Email: [email protected]
Original
Antipsychotic polypharmacy and quality of life in patients with schizophrenia treated in primary care in China
Cai-Lan Hou, Xin-Rong Ma, Yu Zang, Fu-Jun Jia, Yong-Qiang Lin, Helen F.K. Chiu, Gabor S. Ungvari, Chee H. Ng, Bao-Liang Zhong, Xiao-Lan Cao, Yan Li, Mei-Ying Cai, and Yu-Tao Xiang
Price
42.00 $
Page No. 36
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 1/2016 (36-42)
Antipsychotic polypharmacy and quality of life in patients with schizophrenia treated in primary care in China
Cai-Lan Hou1*, Xin-Rong Ma2,3*, Yu Zang4*, Fu-Jun Jia1, Yong-Qiang Lin1, Helen F.K. Chiu5, Gabor S. Ungvari6, Chee H. Ng7, Bao-Liang Zhong5, Xiao-Lan Cao4, Yan Li5, Mei-Ying Cai8, and Yu-Tao Xiang9
1Guangdong Mental Health Center, Guangdong General Hospital & Guangdong Academy of Medical Sciences, 2Southern Medical University, Guangdong Province, 3Ningxia Mental Health Center, Ningxia Ning-An Hospital, Ningxia Province, 4Shenzhen Key Laboratory for Psychological Healthcare & Shenzhen Institute of Mental Health, Shenzhen Kangning Hospital & Shenzhen Mental Health Center, Shenzhen, 5Department of Psychiatry, Chinese University of Hong Kong, Hong Kong SAR, China, 6School of Psychiatry & Clinical Neurosciences, University of Western Australia, Perth, 7Department of Psychiatry, University of Melbourne, Melbourne, Victoria, Australia, and 8Guangzhou Yuexiu Center for Disease Control and Prevention, Guangdong Province, and 9Unit of Psychiatry, Faculty of Health Sciences, University of Macau, Macao SAR, China
Objective: In China, maintenance treatment for clinically stable patients with schizophrenia is usually provided by primary care physicians, but their prescribing patterns have not been studied. This study examined the frequency as well as demographic and clinical correlates of antipsychotic polypharmacy (APP) and its impact on quality of life (QOL) in patients with schizophrenia treated in primary care in China. Method: A total of 623 community-dwelling patients from 18 randomly selected primary care services were interviewed. Patients’ socio-demographic and clinical characteristics, including number of hospitalizations, antipsychotic drug-induced side effects, and QOL were recorded using a standardized protocol and data collection procedure. Results: The rate of APP prescription was 31% (193/623). Of the patients on APP, 89.6% received 2 antipsychotics, 10.4% received 3 or more antipsychotics. Clozapine (35.6%) was the most commonly prescribed second generation antipsychotic (SGA), while perphenazine (17.8%) was the most commonly prescribed first generation antipsychotic (FGA). Multiple logistic regression analyses revealed that patients on APP were more likely to receive SGAs and anticholinergics, had fewer hospitalizations, younger age of onset, and higher doses of antipsychotics. There were no significant differences between the two groups in any of the QOL domains. Conclusions: Approximately a third of Chinese patients with schizophrenia in primary care receive APP. Further examination of the rationale and appropriateness of APP and its alternatives is warranted.
*These authors contributed equally to the paper.Correspondence to:
Dr. Fu-Jun Jia
Guang Dong Mental Health Centre
Guangdong province, China
or
Dr. Yu-Tao Xiang
3/F, Building E12
Faculty of Health Sciences, University of Macau
Avenida da Universidade, Taipa, Macau SAR, China
Email: [email protected]; or [email protected]
Original
Investigation of a potential pharmacokinetic interaction between perindopril arginine and amlodipine when administered as a single perindopril/amlodipine fixed-dose combination tablet in healthy Chinese male volunteers
Xin Zheng, Tao Liu, Xia Chen, Xiaoyan Chen, Ji Jiang, and Pei Hu
Price
42.00 $
Page No. 43
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 1/2016 (43-51)
Investigation of a potential pharmacokinetic interaction between perindopril arginine and amlodipine when administered as a single perindopril/amlodipine fixed-dose combination tablet in healthy Chinese male volunteers
Xin Zheng, Tao Liu, Xia Chen, Xiaoyan Chen, Ji Jiang, and Pei Hu
Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Beijing, China
Objectives: To determine whether a potential pharmacokinetic interaction exists between perindopril arginine 5 mg and amlodipine 5 mg, after administration as a fixed-combination of perindopril 5 mg/amlodipine 5 mg (S05985). Methods: A total of 30 subjects was enrolled into this single center, open-label, randomized, 3-period cross-over study and was randomized to receive 1 tablet of S05985, 1 tablet of perindopril tert-butylamine 4 mg, or 1 tablet of amlodipine 5 mg. The doses of both perindopril salts correspond to 3.34 mg of perindopril expressed as free acid. Serial blood samples were collected in each treatment period for determination of plasma amlodipine, perindopril, and perindoprilat concentrations and for calculation of the respective pharmacokinetic parameters (AUC0–∞, AUC0–t, Cmax, and tmax). Statistical analyses of the pharmacokinetic parameters included ANOVA and calculations of 90% confidence intervals for the ratio of the geometric means for Cmax, AUC0–t, and AUC0–∞. Safety was also assessed. Results: A total of 29 subjects completed the study per protocol. There was no serious adverse event. All 90% confidence intervals for Cmax, AUC0–t, and AUC0–∞ for perindopril, perindoprilat, and amlodipine were within the limits (80.00 – 125%), indicating that both treatments were bioequivalent. Conclusion: These results indicate that no drug-drug interaction exists after single-dose oral administration of S05985 (perindopril 5 mg and amlodipine 5 mg) when compared to single-dose administration of each component alone, i.e., perindopril tert-butylamine 4 mg and amlodipine 5 mg, given separately.Correspondence to:
Pei Hu, MD
Clinical Pharmacology Research Center
Peking Union Medical College Hospital
No. 4, Damucang Hutong, Xicheng District, Beijing 10032, China
Email: [email protected]
Case Report
The use of unboosted darunavir in the setting of ritonavir intolerance: three case reports
Katelyn Smith, Denese Gomes, Daniel Nixon, and Patricia Pecora Fulco
Price
42.00 $
Page No. 52
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 1/2016 (52-57)
The use of unboosted darunavir in the setting of ritonavir intolerance: three case reports
Katelyn Smith1*, Denese Gomes2, Daniel Nixon2, and Patricia Pecora Fulco2
1Notre Dame of Maryland University School of Pharmacy, Baltimore, MD, and 2Virginia Commonwealth University Health System, Richmond VA, USA
Objective: To describe three patients with human immunodeficiency virus (HIV) who were successfully managed with unboosted darunavir (uDRV). Case summaries: The three cases included one woman and two men aged 58, 54, and 51 years, respectively. All patients were HIV positive and unable to tolerate ritonavir-boosted protease inhibitors secondary to significant gastrointestinal intolerance. Unboosted darunavir was tolerated without any further issues when prescribed with an optimized antiretroviral (ARV) background regimen. Despite low darunavir (DRV) concentrations, all three patients achieved a virologic response. Discussion: Darunavir is a relatively well-tolerated ARV, but concurrent ritonavir administration has several disadvantages (e.g., dose-related hyperlipidemia, gastrointestinal intolerance, drug-drug interactions) which may decrease patient adherence. The use of uDRV may be particularly useful in patients with limited therapy options who are unable to tolerate ritonavir-boosted protease inhibitors. Therapeutic drug monitoring (TDM) was performed as unboosted DRV has a bioavailability of 37% and the virologic and immunologic response has only been demonstrated with ritonavirboosted DRV. Conclusion: Successful use of uDRV may be an acceptable ARV option in carefully selected patients with limited treatment options, particularly when an optimized background regimen is included. Darunavir TDM should be strongly considered if uDRV is initiated.
*At the time of the case reports, Dr. Smith was a PGY2 Internal Medicine Pharmacy Resident at the Virginia Commonwealth University Health System in Richmond, VA, USACorrespondence to:
Patricia Pecora Fulco, PharmD, BCPS, FASHP
Virginia Commonwealth University Health System
401 North 12th Street, Richmond VA 23298-0042, USA
Email: [email protected]
Case Report
Ifosfamide and etoposide chemotherapy may interact with warfarin, enhancing the warfarininduced anticoagulant response
Naoto Okada, Hiroyoshi Watanabe, Shoji Kagami, and Keisuke Ishizawa
Price
42.00 $
Page No. 58
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 1/2016 (58-61)
Ifosfamide and etoposide chemotherapy may interact with warfarin, enhancing the warfarininduced anticoagulant response
Naoto Okada1, Hiroyoshi Watanabe2, Shoji Kagami2, and Keisuke Ishizawa1,3
1Department of Pharmacy, Tokushima University Hospital, 2Department of Pediatrics, and 3Department of Clinical Pharmacy, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, Japan
Purpose: To report a case of warfarin-response enhancement during administration of ifosfamide and etoposide chemotherapy. Case summary: A 15-yearold boy with rhabdomyosarcoma was treated with a regimen of alternating cycles of vincristine, doxorubicin, and cyclophosphamide (VDC) chemotherapy and ifosfamide and etoposide (IE) chemotherapy. During VDC chemotherapy, occlusion of the left middle cerebral artery occurred, and warfarin was started. On day 3 of IE chemotherapy, the patient’s international normalized ratio (INR) transiently increased from baseline 2.61 to 5.45. The INR returned to normal within 3 days after warfarin discontinuation. An increase in INR was observed between days 1 and 3 of subsequent cycles of IE chemotherapy but not during VDC chemotherapy. This INR increase was also observed during concomitant use of aprepitant, an inducer of the CYP2C9. Discussion: There are no reports describing the interaction between warfarin and IE chemotherapy because coadministration of warfarin and IE chemotherapy is unusual. The Drug Interaction Probability Scale score of this interaction was 7, and it is probable that the enhancement of the warfarin response was caused by an interaction with IE chemotherapy. Moreover, in the present case, the enhancement of warfarin response was observed during concomitant use of aprepitant, which has been reported to weaken the warfarin response. Therefore, this interaction may be quite powerful and may increase the risk of warfarin toxicity. Conclusion: A patient who was administered both warfarin and IE chemotherapy experienced a rapid increase in INR, suggesting that INR should be closely monitored in patients receiving warfarin with IE chemotherapy.Correspondence to:
Naoto Okada
Department of Pharmacy
Tokushima University Hospital
2-50-1 Kuramoto, Tokushima 770-8503, Japan
Email: [email protected]
Case Report
Large doses of uterotonic drugs caused type II second degree sinoatrial block during cesarean section
Zhe-Feng Quan, Ming Tian, and Ping Chi
Price
42.00 $
Page No. 62
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 1/2016 (62-64)
Large doses of uterotonic drugs caused type II second degree sinoatrial block during cesarean section
Zhe-Feng Quan1, Ming Tian2, and Ping Chi1
1Department of Anesthesiology, Beijing YouAn Hospital, and 2Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China
In China, it is a routine procedure to inject 250 μg of hemabate (sterile solution, an oxytocic, contains the tromethamine salt of the (I5S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection) into the myometrium of patients experiencing uterine inertia after delivery, with an additional dose given in the event that the efficacy is not obvious. Although hemabate is prohibited from being used in patients with active liver disease, there are no restrictions regarding the application of hemabate in positive hepatitis B surface antigen (HbsAg)-positive subjects with normal liver function. Here we report adverse effects of hemabate in 1 HbsAg-positive subject with normal liver function. This subject experienced increased blood pressure, chest tightness, and type II second degree sinoatrial block 25 minutes after an additional injection of hemabate. Thus, special attention should be paid when applying hemabate in HbsAgpositive subjects with normal liver function.Correspondence to:
Ming Tian, MD, PhD
Department of Anesthesiology
Beijing Friendship Hospital
Capital Medical University
100069 Beijing, China
Email: [email protected]
Bioavailability Section
Bioequivalence study of an extemporaneously prepared oral solution of amlodipine suitable for use in pediatric patients compared to commercial tablets
Anna C. van der Vossen, Iris van der Velde, Anton H. van den Meiracker, Bart C.H. van der Nagel, Birgit C.P. Koch, Arnold G. Vulto, and Lidwien M. Hanff
Price
42.00 $
Page No. 65
Abstract
Bioequivalence study of an extemporaneously prepared oral solution of amlodipine suitable for use in pediatric patients compared to commercial tablets
Anna C. van der Vossen1, Iris van der Velde1, Anton H. van den Meiracker2, Bart C.H. van der Nagel1, Birgit C.P. Koch1, Arnold G. Vulto1, and Lidwien M. Hanff1
1Department of Hospital Pharmacy, and 2Department of Internal Medicine, Erasmus Medical Center, Rotterdam, The Netherlands
Objective: Amlodipine, a long-acting dihydropyridine calcium channel blocker, is frequently prescribed to pediatric patients. To date, no suitable pediatric formulation has been available. In this study, an amlodipine oral solution was developed and tested for bioequivalence to tablets in healthy adult volunteers. Methods: This study was designed as an open-label, single-dose, twosequence, two-period, crossover trial to assess the bioequivalence of a newly developed amlodipine besylate oral solution 0.5 mg/mL compared to Norvasc® 5 mg tablets. 13 adult subjects (mean [standard deviation] age of 23.2 [3.6] years, weight 71.5 [7.7] kg) were included and blood samples were collected for 72 hours. Amlodipine plasma levels were determined using a validated UPLC-MS/MS assay. Non-compartmental pharmacokinetic parameters were compared between the formulations according to European Medicines Agency (EMA) bioequivalence guidelines. Results: The 90% confidence intervals of the test/reference ratios of the geometric means for the primary pharmacokinetic parameters AUC0–72 (88.24 – 104.37%) and Cmax (99.00 – 121.40%) were within the acceptance range of 80.00 – 125.00% for bioequivalence. Mean (SD) AUC0–72 was 102.7 (26.8) μg×h/L for the solution and 108.2 (30.6) μg×h/L for the tablet. Mean (SD) Cmax of the solution was 3.11(1.06) μg/L with a median (IQR) tmax of 4.0 (2.6 – 7.5) hours. Mean (SD) Cmax of the tablet was 2.91 (0.84) μg/L with a median (IQR) tmax of 6.0 (4.0 – 14.0) hours. Intrasubject coefficients of variation were 10.2% (AUC0–72) and 12.4% (Cmax). Conclusions: The formulations are bioequivalent according to EMA guidelines. This warrants further study of our novel amlodipine oral solution in pediatric patients.Correspondence to:
Anna C. van der Vossen, PharmD
Department of Hospital Pharmacy Erasmus MC
PO Box 2040, 3000 CA Rotterdam, The Netherlands
Email: [email protected]
Book Review
The Challenge of Drug- Induced Liver Injury (DILI)/ Challenges and Management of Liver Cirrhosis
Walter E. Haefeli and Barry G. Woodcock
Page No. 73
Abstract
The Challenge of Drug- Induced Liver Injury (DILI)/ Challenges and Management of Liver Cirrhosis
Walter E. Haefeli and Barry G. Woodcock
Erratum
Pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol as a triple therapy in healthy volunteers
Alex Henderson, on behalf of all authors
Page No. 76
Abstract
Intern. Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 1/2016 – Erratum
Pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol as a triple therapy in healthy volunteers
Alex Henderson, on behalf of all authors
Erratum to the article “Pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol as a triple therapy in healthy volunteers” by Noushin Brealey, Ashutosh Gupta, Jessica Renaux, Rashmi Mehta, Ann Allen, and Alex Henderson in International Journal of Clinical Pharmacology and Therapeutics, Vol. 53 – No. 9/2015, pp 753-764
