Volume 54, No. 3/2016(March)
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Original
No sex difference in overall P-glycoprotein activity as assessed by talinolol disposition in humans
Bo Long, Yuan-qi Su, Ying Xia, Yan-ye Zou, Bo Tang, Zhong-jie Chen, and Yu Lin
Price
42.00 $
Page No. 157
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 3/2016 (157-162)
No sex difference in overall P-glycoprotein activity as assessed by talinolol disposition in humans
Bo Long1*, Yuan-qi Su2*, Ying Xia2, Yan-ye Zou3, Bo Tang3, Zhong-jie Chen3, and Yu Lin3
1Chongqing Cancer Institute, 2Department of Pharmacology, Chongqing Medical and Pharmaceutical College, and 3Department of Pharmacology and Toxicology, Chongqing Pharmaceutical Research Institute, Chongqing, China
Purpose: The aim of this study was to investigate the sex-dependent difference in P-glycoprotein activity as measured by the probe drug talinolol. Methods: A randomized, single-blind, parallel study was carried out in 20 healthy male and 20 healthy female volunteers. The pharmacokinetics of talinolol were measured after single oral dosing of 50-mg tablet and the pharmacokinetic parameters for male and female subjects were compared after excluding the potential influence of P-gp genetic polymorphisms. Results: Talinolol AUC0–48h in the female subjects was 23.5% (p = 0.003) higher than that of male subjects. There was no significant sex difference in weight-corrected oral clearance, AUC, or other PK parameters. Conclusion: The AUC and other PK data of talinolol, corrected for body weight, did not differ between genders after oral administration. The observed sex difference in talinolol systemic exposure is of little clinical relevance. The overall activity of P-gp shows no sex-related difference.
*Both authors contributed equally.Correspondence to:
Yu Lin
Department of Pharmacology and Toxicology
Chongqing Pharmaceutical Research Institute
565# Tushan Road, Na’an District
400061 Chongqing, China
Email: [email protected]
Original
Association of immune response parameters with virological response in hepatitis C virus patients treated with pegylated consensus interferon
Yanhua Ding, Hong Zhang, Hong Chen, Xiaojiao Li, Chengjiao Liu, Qingmei Li, and Junqi Niu
Price
42.00 $
Page No. 163
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 3/2016 (163-171)
Association of immune response parameters with virological response in hepatitis C virus patients treated with pegylated consensus interferon
Yanhua Ding, Hong Zhang, Hong Chen, Xiaojiao Li, Chengjiao Liu, Qingmei Li, and Junqi Niu
Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China
Background: A new, potent, long lasting recombinant interferon variant (pegylated consensus interferon, PEGCIFN) was expressed by Escherichia coli. The aim of this study was to test safety and antiviral activity of the new type of interferon in adults with hepatitis C virus (HCV) infection and to determine the relationship between immune response markers and virological response. Method: 40 naive HCV patients (1 : 1 : 1 : 1) were injected subcutaneously with PEG-CIFN 1.0, 1.5, 2.0 μg/kg and peginterferon-α 180 μg once per week for 12 weeks. Serum HCV RNA, cytokines, chemokines levels were tested, and clinical data were collected at this course. Results: PEG-CIFN is safety/tolerability. The serum HCV RNA levels were markedly decreased after therapy. 20% (2/10), 70% (7/10), 70% (7/10), and 60% (6/10) exhibited early virologic responses (EVR (+)) during PEGCIFN 1.0, 1.5, and 2.0 μg/kg treatment and peginterferon-α 180 μg treatment, respectively. Interleukin-4, interferon induced protein 10 (IP-10), and macrophage inflammatory protein 1β (MIP-1β) levels were lower, and granulocyte colony-stimulating factor levels were higher in EVR (+) than in the group not having an EVR (EVR (-)) (p < 0.05) after PEG-CIFN treatment. IP-10 and MIP-1β levels were associated with HCV RNA values, alanine aminotransferase, and aspartate aminotransferase levels after PEG-CIFN treatment. Conclusion: PEGCIFN was well tolerated and effective at inhibiting HCV RNA, which is associated with changes in markers of immune response. PEG-CIFN 1.5 μg/kg has been selected for further hepatitis C clinical development.Correspondence to:
Dr. Junqi Niu
Phase I Clinical Trial Unit, The First Hospital
Jilin University, Changchun 130021, China
Email: [email protected]
Original
Inappropriate prescribing in elderly outpatients taking multiple medications. Are the STOPP criteria useful?
María Luisa Nicieza-Garcia, María Esther Salgueiro-Vázquez, Francisco José Jimeno-Demuth, and Gloria Manso
Price
42.00 $
Page No. 172
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 3/2016 (172-176)
Inappropriate prescribing in elderly outpatients taking multiple medications. Are the STOPP criteria useful?
María Luisa Nicieza-Garcia1, María Esther Salgueiro-Vázquez2, Francisco José Jimeno-Demuth2, and Gloria Manso2
1Servicio de Farmacia de Atención Primaria, Hospital Carmen y Severo Ochoa, Asturias, and 2Departamento de Medicina, Área de Farmacología, Universidad de Oviedo, Asturias, Spain
Objective: To assess potentially inappropriate medications (PIMs) in elderly outpatients taking multiple medications. Methods: Invoicing data of the prescriptions and electronic medical records were used to apply the STOPP (screening tool of older people’s prescriptions) criteria. Results: Three out of 4 patients included in the study received PIMs. The most common criteria found were: duplicate drug class prescriptions (n = 58 (17.4%)), long-term long-acting benzodiazepines (n = 54 (16.2%)), and acetylsalicylic acid with no history of coronary, cerebral, or peripheral vascular symptoms or occlusive event (n = 32 (9.6%)). Conclusion: Our results highlight the relevance of the systematic review of the pharmacological treatments in these patients.Correspondence to:
Dr. Gloria Manso
Departamento de Medicina, Área de Farmacología
Julián Clavería 6, 33006 Oviedo, Spain
Email: [email protected]
Original
Micro-optical prototyping of a surface acoustic wave-based point-of-care coagulation assay and first application in anticoagulated patients
Jochen Moll, Sascha Meyer dos Santos, Bernd Hils, Fabian Dornuf, Isabel Rodrigues Meyer dos Santos, Oliver C. Singer, Nerea Ferreirós, Sandra Labocha, Annemarie Blücher, Sebastian Harder, and Viktor Krozer
Price
42.00 $
Page No. 177
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 3/2016 (177-184)
Micro-optical prototyping of a surface acoustic wave-based point-of-care coagulation assay and first application in anticoagulated patients
Jochen Moll1*, Sascha Meyer dos Santos2,3*, Bernd Hils1*, Fabian Dornuf1, Isabel Rodrigues Meyer dos Santos4, Oliver C. Singer4, Nerea Ferreirós3, Sandra Labocha3, Annemarie Blücher3, Sebastian Harder3, and Viktor Krozer1
1Department of Physics, Terahertz Photonics, Goethe University of Frankfurt, 2Project Group Translational Medicine and Pharmacology, Fraunhofer Institute IME, 3Department of Clinical Pharmacology, and 4Department of Neurology, University Hospital Frankfurt, Frankfurt am Main, Germany
Objective: Clinicians demand for methods to monitor effects of direct anticoagulants in the emergency setting. We recently described a coagulation assay based on surface acoustic waves (SAW) technology, which quantifies anticoagulant effects by image processing. Here we describe the first step in miniaturizing this laboratory method and provide a portable prototype that contains the optical illumination and automatic on-board image processing. Methods: A device about the size of a shoebox was realized that contains the SAW-chip, the signal generator, the LED illumination, as well as the necessary lenses, aperture, and CCD sensor. The microspheres in the blood were mixed by SAW, and the movement of the microspheres was quantified by on-board image processing. Upon contact with activationinduced coagulation, this movement ceases, and coagulation times were measured and compared to the manual methods obtained by standard fluorescent microscopy. A major advantage of our method is the low amount of blood (~ 6 μL) necessary for testing. Results: Results from the prototype correlated accurately with manual methods (Pearson correlation coefficient r = 0.9644). SAW-induced clotting time under anticoagulant treatment with dabigatran or rivaroxaban was well correlated with physicochemically determined plasma concentrations of these DOACs in anticoagulated patients. Compared to manual alignment of the chip under the fluorescence microscope, the prototype had a lower coefficient of variation. Conclusions: The last evolution step towards a point-of-care (POC)-device would be the development of a cartridge (containing calcium chloride and fluorescent label) such that a drop of blood can be introduced into the reaction vessel by a fluid actuator system.
*contributed equallyCorrespondence to:
Prof. Dr. med. Sebastian Harder
Goethe University of Frankfurt am Main
Department of Clinical Pharmacology
Theodor-Stern-Kai 7
60596 Frankfurt am Main, Germany
Email: [email protected]
Original
Intrathecal dexmedetomidine as adjuvant to ropivacaine in hysteroscopic surgery: a prospective, randomized control study
Xiaofei Qi, Yuantao Li, Niels Rahe-Meyer, Xiaolei Huang, Yin Gu, Xiaoguang Wang, Yong Li, and Yajie Wen
Price
42.00 $
Page No. 185
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 3/2016 (185-192)
Intrathecal dexmedetomidine as adjuvant to ropivacaine in hysteroscopic surgery: a prospective, randomized control study
Xiaofei Qi1, Yuantao Li1, Niels Rahe-Meyer2, Xiaolei Huang1, Yin Gu1, Xiaoguang Wang1, Yong Li1, and Yajie Wen1
1Department of Anesthesiology, Shenzhen Maternity and Child Healthcare Hospital, Southern Medical University, Shenzhen, Guangdong, China, and 2Anesthesiology Department of Franziskus Hospital, Bielefeld, Germany
Background: To compare the effects and side effects of intrathecal ropivacaine supplemented with dexmedetomidine and fentanyl in hysteroscopic surgery under spinal anesthesia. Methods: Female patients (n = 108) undergoing operative hysteroscopic procedures under spinal anesthesia were randomly allocated to the following groups for subarachnoid drug delivery: R (n = 36) received 7.5 mg ropivacaine; RD (n = 36) received 7.5 mg ropivacaine plus 5 μg dexmedetomidine; RF (n = 36) received 7.5 mg ropivacaine plus 15 μg fentanyl. The onset and regression time of sensory and motor blockade, together with the postoperative analgesia and side effects were recorded. Results: There was no significant difference as to sensory and motor onset time between groups. RD had significantly longer sensory and motor blockade time than RF and R. The mean time of sensory regression to the S1 segment was 191.25 ± 40.24 minutes in RD, 149.86 ± 37.46 minutes in RF, and 139.44 ± 38.97 minutes in R (RD vs. R and RD vs. RF, p < 0.001). The regression time of motor blockade to Bromage score 0 was 146.31 ± 40.72 minutes in RD, 80.28 ± 41.18 minutes in RF, and 84.94 ± 26.11 minutes in R (RD vs. R and RD vs. RF, p < 0.001). RD produced similar analgesia effect with RF, (2 hour visual analog scale (VAS) was 0.00 ± 0.00 and 0.31 ± 0.79, respectively) better than the R group (1.35 ± 1.65, p < 0.005). No pruritus occurred in the RD group, while the rate was 36.1% in the RF group. However, the RD group produced milder postsurgical hypotension (RD vs. R and RD vs. RF, p < 0.05). Conclusion: Intrathecal dexmedetomidine (5 μg) produced prolonged motor and sensory blockade and less pruritus compared with fentanyl (15 μg) in hysteroscopic surgery.Correspondence to:
Yuantao Li, PhD, MD
Department of Anesthesiology
Shenzhen Maternity and Child Healthcare Hospital
Southern Medical University
Shenzhen 518028, Guangdong, China
Email: [email protected]
Original
Effects of UGT1A1*6, UGT1A1*28, and ABCB1-3435C>T polymorphisms on irinotecaninduced toxicity in Chinese cancer patients
Liang Yan, Xiao-fei Wang, Lu-man Wei, Ya-li Nie, Jing-yang Liu, and Li-rong Zhang
Price
42.00 $
Page No. 193
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 3/2016 (193-199)
Effects of UGT1A1*6, UGT1A1*28, and ABCB1-3435C>T polymorphisms on irinotecaninduced toxicity in Chinese cancer patients
Liang Yan1*, Xiao-fei Wang2*, Lu-man Wei1, Ya-li Nie1, Jing-yang Liu1, and Li-rong Zhang1
1Department of Pharmacology, School of Basic Medical Sciences, Zhengzhou University, and 2Translational Medicine Center, Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou, China
Object: The aim of this study was to investigate whether UGT1A1*6/*28 or ABCB1-3435C>T polymorphisms affect irinotecan-induced severe diarrhea and neutropenia in Chinese cancer patients. Methods: A total of 157 cancer patients was enrolled in this study and the genotypes of UGT1A1*6/*28 and ABCB1-3435C>T polymorphisms were analyzed by PCRSanger sequence. The relationship between UGT1A1*6/*28 and ABCB1-3435C>T polymorphisms and irinotecan induced severe diarrhea and neutropenia were analyzed. Results and conclusion: UGT1A1*6 and UGT1A1*28 polymorphisms were associated with severe neutropenia (p = 0.025, p = 0.022, respectively) but not diarrhea (p = 0.343, p = 0.185, respectively), and ABCB1- 3435C>T polymorphism was not associated with irinotecan induced severe toxicities (p = 0.457, p = 0.161, respectively).Correspondence to:
Prof. Li-rong Zhang, MD
Department of Pharmacology
School of Basic Medical Sciences
Zhengzhou University
100 Science Road, Zhengzhou 450001, China
Email: [email protected]
Original
Population pharmacokinetics study of dexmedetomidine in Chinese adult patients during spinal anesthesia
Yun Kuang, Yu-xia Xiang, Cheng-Xian Guo, Ran-ran Zhang, Guo-Ping Yang, Guan-feng Hou, Hong-yi Tan, Lu Huang, Jie Huang, Wen Ouyang, Kai-ming Duan, Sai-ying Wang, Jing-le Li, and Qi Pei
Price
42.00 $
Page No. 200
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 3/2016 (200-207)
Population pharmacokinetics study of dexmedetomidine in Chinese adult patients during spinal anesthesia
Yun Kuang1,2*, Yu-xia Xiang1*, Cheng-Xian Guo1*, Ran-ran Zhang1, Guo- Ping Yang1, Guan-feng Hou3, Hong-yi Tan1, Lu Huang1, Jie Huang1, Wen Ouyang4, Kai-ming Duan4, Sai-ying Wang4, Jing-le Li5, and Qi Pei1
1Center of Clinical Pharmacology, Third Xiangya Hospital, 2School of Pharmaceutical Science, Central South University, Changsha, 3Department of Anesthesiology, Anhui Provincial Hospital, Hefei, 4Department of Anesthesiology, and 5Department of Cardiology, Third Xiangya Hospital, Central South University, Changsha, China
Objectives: The objectives of this study were to construct a population pharmacokinetics model for dexmedetomidine used in Chinese adult patients with spinal anesthesia and to identify the key factors affecting the pharmacokinetics of dexmedetomidine. Methods: A total of 34 subjects (elderly group: n = 15; young group: n = 19) undergoing spinal anesthesia received dexmedetomidine with a loading dose of 0.5 μg×kg–1 for 10 minutes, followed by a maintenance dose of 0.5 μg×kg–1×h–1 for 50 minutes. Blood samples were collected until 10 hours after dosing. Laboratory and respiratory parameters, and dexmedetomidine concentrations were measured. A population pharmacokinetic model for dexmedetomidine was constructed using a nonlinear mixed effects model (NONMEM). Results: Pharmacokinetics of dexmedetomidine can be described by a three-compartment model. The respective typical values for clearance (CL), V1, V2, Q2, Q3, and V3 were 0.883 L×min–1, 17.6 L, 51.5 L, 2.37 L×min–1, 0.517 L×min–1, and 44.00 L. Alanine aminotransferase (ALT), age, and body weight were key factors affecting CL, V1, and V2, respectively. Conclusions: A three-compartment model can be used to describe the pharmacokinetics processing of dexmedetomidine for Chinese adult patients during spinal anesthesia. The population pharmacokinetic of dexmedetomidine was generally in line with results from previous studies.Correspondence to:
Qi Pei, PhD
Center of Clinical Pharmacology
The Third Xiangya Hospital
Central South University
Changsha, Hunan 410013, China
Email: [email protected] and [email protected]
Case Report
Sisters who developed piloerection after administration of milnacipran
Nobuko Matsuo, Satoko Hori, Mayu Suehira, Hiroki Satoh, Akiko Miki, and Yasufumi Sawada
Price
42.00 $
Page No. 208
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 3/2016 (208-211)
Sisters who developed piloerection after administration of milnacipran
Nobuko Matsuo1, Satoko Hori2,3, Mayu Suehira4, Hiroki Satoh3, Akiko Miki3, and Yasufumi Sawada3
1Dream Pharmacy, Kusatsu-shi, Shiga, 2Interfaculty Initiative in Information Studies, 3Laboratory of Drug Lifetime Management, Graduate School of Pharmaceutical Sciences, The University of Tokyo, and 4Drug Lifetime Management Center, Tokyo, Japan
Objective: We previously reported the first case of piloerection in a patient receiving milnacipran hydrochloride (MLP). Here, we now present a second case of MLP-induced piloerection. We discuss this effect in terms of α1-adrenoceptor occupancy. Case summary: After the first case of MLP-induced piloerection, we monitored occurrence of piloerection in our patients taking MLP. In response to our interview, a 43-year-old woman who had been prescribed MLP by a psychiatrist for depression mentioned that piloerection occurred frequently all over her body, starting soon after initiation of MLP administration (50 mg/day). Although she was concerned at the time, she assumed it might be related to her depression or to coldness in winter. She also mentioned that the incidence of piloerection increased with MLP dose escalation. The piloerection disappeared after several months. Interestingly, the previous patient and the current patient are biological sisters. Discussion: Changes in α1-adrenoceptor occupancy by endogenous norepinephrine (as an index of the risk of piloerection) in the presence of MLP were estimated. The occupancy values increased with MLP dose escalation, in accordance with the patient’s report of the phenomenon. other concomitant drugs, such as nortriptyline, had little effect. Since the two patients were sisters, genetic factors might influence the risk of piloerection. Conclusion: The incidence of piloerection appeared to increase with MLP dose escalation in this patient, who was the biological sister of the previously reported patient. Clinicians should recognize the possibility of MLPinduced piloerection in view of its potential impact on patients’ quality of life and on drug compliance.Correspondence to:
Prof. Yasufumi Sawada
Laboratory of Drug Lifetime Management
Graduate School of Pharmaceutical Sciences
The University of Tokyo
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
Email: [email protected]
Bioavailability Section
Bioequivalence study of two rosuvastatin tablet formulations in healthy Indonesian subjects
Yahdiana Harahap, Budi Prasaja, Fahmi Azmi, Windy Lusthom, Theresia Sinandang, Vita Felicia, Lia Yumi Yusvita, and Lianna Y. Panjaitan
Price
42.00 $
Page No. 212
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 3/2016 (212-216)
Bioequivalence study of two rosuvastatin tablet formulations in healthy Indonesian subjects
Yahdiana Harahap1*, Budi Prasaja2, Fahmi Azmi2, Windy Lusthom2, Theresia Sinandang2, Vita Felicia2, Lia Yumi Yusvita2, and Lianna Y. Panjaitan2
1Faculty of Pharmacy, Universitas Indonesia, Depok, and 2PT. Clinisindo Laboratories, Jakarta, Indonesia
Aim: To compare the bioavailability of two 40-mg Rosuvastatin tablet formulations. Methods: 24 subjects were included in this single-dose, open-label, randomized, two-way crossover study following an overnight fast. A 2-week wash out period was applied. Blood samples were drawn up to 72 hours following drug administrations. Rosuvastatin plasma concentrations were determined by liquid chromatography-tandem mass spectrometry method with TurboIon-Spray mode. Pharmacokinetic parameters AUC0–t, AUC0–∞, and Cmax were determined and used for bioequivalence evaluation after log-transformation, whereas tmax ratios were evaluated nonparametrically. Results: The estimated point and 90% confidence intervals (CI) for AUC0–t, AUC0–∞, and Cmax for rosuvastatin were 95.21% (87.56 – 103.53%), 95.76% (88.01 – 104.18%), and 99.33% (89.37 – 110.41%), respectively. Conclusion: These results indicated that the two formulations of rosuvastatin were bioequivalent; therefore, they may be prescribed interchangeably.Correspondence to:
Dr. Yahdiana Harahap
Faculty of Pharmacy, Universitas Indonesia
Depok, Indonesia
Email: [email protected] and [email protected]
Bioavailability Section
Relative bioavailability, food effect, and safety of the single-dose pharmacokinetics of omecamtiv mecarbil following administration of different modified-release formulations in healthy subjects
Rameshraja Palaparthy, Christopher Banfield, Paco Alvarez, Lucy Yan, Brian Smith, Jessica Johnson, Maria Laura Monsalvo, and Fady Malik
Page No. 217
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 3/2016 (217-227)
Relative bioavailability, food effect, and safety of the single-dose pharmacokinetics of omecamtiv mecarbil following administration of different modified-release formulations in healthy subjects
Rameshraja Palaparthy1, Christopher Banfield1, Paco Alvarez2, Lucy Yan2, Brian Smith1, Jessica Johnson2, Maria Laura Monsalvo2, and Fady Malik3
1Formerly Amgen Inc., 2One Amgen Center Drive, Amgen Inc., Thousand Oaks, CA, and 3Cytokinetics, Inc., South San Francisco, CA, USA
Objective: Omecamtiv mecarbil is a novel small molecule that directly activates cardiac myosin and increases cardiac contractility without increasing cardiac myocyte intracellular calcium. This study evaluated the relative bioavailability, food effect, and safety of several modified-release (MR) formulations of omecamtiv mecarbil. Methods: This was a phase 1, randomized, openlabel, 4-way crossover, incomplete blockdesign study evaluating 5 MR formulations of omecamtiv mecarbil vs. an immediaterelease (IR) formulation. Materials: Healthy subjects were randomized to 1 of 30 possible sequences: within each sequence, subjects were assigned to receive a single 25-mg dose of 2 of the 6 possible formulations in the fasting and/or fed states. Results: 65 subjects were screened and enrolled; 5 were replacement subjects. Pharmacokinetic and safety data were analyzed from 62 and 63 subjects in the fasting and fed states, respectively. Compared with the IR formulation, median tmax was longer (0.5 vs. 2 – 10 hours), and mean Cmax was lower for all 5 MR formulations (262 vs. 34 – 78 ng/mL); t1/2,z was similar (18 – 21 hours). The relative bioavailability was high (> 75%) for three MR formulations but lower (< 65%) for the other two. Overall, the effect of food on omecamtiv mecarbil pharmacokinetics was minimal for four of the MR formulations. The pharmacokinetics of the inactive metabolites M3 and M4 were similar across all formulations. Conclusions: The relative bioavailability of omecamtiv mecarbil was high (> 75%) for 3 of the five MR formulations. Food had a marginal, nonclinically meaningful effect on the pharmacokinetics of the MR formulations of omecamtiv mecarbil.Correspondence to:
Rameshraja Palaparthy, PhD
Clinical Pharmacology, Oncology Biotechnology
Clinical Development, Pfizer Worldwide R&D
San Diego, CA 92121,USA
Email: [email protected]
Book Review
Clinical Handbook of Psychotropic Drugs
J. Rösner and Barry G. Woodcock
Page No. 228
Abstract
J. Rösner and Barry G. Woodcock
