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Mass spectrometry for drug discovery and drug development [[electronic resource] /] / edited by Walter A. Korfmacher
| Mass spectrometry for drug discovery and drug development [[electronic resource] /] / edited by Walter A. Korfmacher |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2013 |
| Descrizione fisica | 1 online resource (478 p.) |
| Disciplina |
615.1
615.19 |
| Altri autori (Persone) | KorfmacherWalter A |
| Collana | Wiley series on mass spectrometry |
| Soggetto topico |
Drugs - Analysis
Mass spectrometry |
| ISBN |
1-118-51615-X
1-283-91752-1 1-118-51612-5 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Overview of the various types of mass spectrometers that are used in drug discovery and drug development / Gerard Hopfgartner -- 2. Utility of high resolution mass spectrometry for new drug discovery applications / William Bart Emary and Nanyan Rena Zhang -- 3. Quantitative mass spectrometry considerations in a regulated environment / Mohammed Jemal and Yuan-Qing Xia -- 4. Mass spectrometry for quantitative in vitro ADME assays / Jun Zhang and Wilson Z. Shou -- 5. Metabolite identification using mass spectrometry in drug development / Natalia Penner, Joanna Zgoda-Pols, and Chandra Prakash -- 6. MS analysis of biological drugs, proteins, and peptides / Yi Du, John Mehl, and Pavlo Pristatsky -- 7. Characterization of impurities and degradation products in small molecule pharmaceuticals and biologics / Hui Wei, Guodong Chen and Adrienne A. Tymiak -- 8. Liquid extraction surface analysis (LESA) : a new mass spectrometry-based technique for ambient surface profiling / Dan Eikel and Jack Henion -- 9. MS applications in support of medicinal chemistry sciences / Maarten Honing, Benno Ingelse, and Birendraÿ N. Pramanik -- 10. Imaging mass spectrometry of proteins and peptides / Michelle L. Reyzer and Richard M. Caprioli -- 11. Imaging mass spectrometry for drugs and metabolites / Stacey R. Oppenheimer -- 12. Screening reactive metabolites : role of liquid chromatography-high resolution mass spectrometry in combination with 'intelligent' data mining tools / Shuguang Ma and Swapan K. Chowdhury -- 13. Mass spectrometry of siRNA / Mark Cancilla and Mike Flanagan -- 14. Mass spectrometry for metabolomics / Petia Shipkova and Michael D. Reily -- 15. Quantitative analysis of peptides with mass spectrometry : selected reaction monitoring or high resolution full scan? / Lieve Dillen and Filip Cuyckens. |
| Record Nr. | UNINA-9910141538503321 |
| Hoboken, N.J., : John Wiley & Sons, c2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Mass spectrometry for drug discovery and drug development [[electronic resource] /] / edited by Walter A. Korfmacher
| Mass spectrometry for drug discovery and drug development [[electronic resource] /] / edited by Walter A. Korfmacher |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2013 |
| Descrizione fisica | 1 online resource (478 p.) |
| Disciplina |
615.1
615.19 |
| Altri autori (Persone) | KorfmacherWalter A |
| Collana | Wiley series on mass spectrometry |
| Soggetto topico |
Drugs - Analysis
Mass spectrometry |
| ISBN |
1-118-51615-X
1-283-91752-1 1-118-51612-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Overview of the various types of mass spectrometers that are used in drug discovery and drug development / Gerard Hopfgartner -- 2. Utility of high resolution mass spectrometry for new drug discovery applications / William Bart Emary and Nanyan Rena Zhang -- 3. Quantitative mass spectrometry considerations in a regulated environment / Mohammed Jemal and Yuan-Qing Xia -- 4. Mass spectrometry for quantitative in vitro ADME assays / Jun Zhang and Wilson Z. Shou -- 5. Metabolite identification using mass spectrometry in drug development / Natalia Penner, Joanna Zgoda-Pols, and Chandra Prakash -- 6. MS analysis of biological drugs, proteins, and peptides / Yi Du, John Mehl, and Pavlo Pristatsky -- 7. Characterization of impurities and degradation products in small molecule pharmaceuticals and biologics / Hui Wei, Guodong Chen and Adrienne A. Tymiak -- 8. Liquid extraction surface analysis (LESA) : a new mass spectrometry-based technique for ambient surface profiling / Dan Eikel and Jack Henion -- 9. MS applications in support of medicinal chemistry sciences / Maarten Honing, Benno Ingelse, and Birendraÿ N. Pramanik -- 10. Imaging mass spectrometry of proteins and peptides / Michelle L. Reyzer and Richard M. Caprioli -- 11. Imaging mass spectrometry for drugs and metabolites / Stacey R. Oppenheimer -- 12. Screening reactive metabolites : role of liquid chromatography-high resolution mass spectrometry in combination with 'intelligent' data mining tools / Shuguang Ma and Swapan K. Chowdhury -- 13. Mass spectrometry of siRNA / Mark Cancilla and Mike Flanagan -- 14. Mass spectrometry for metabolomics / Petia Shipkova and Michael D. Reily -- 15. Quantitative analysis of peptides with mass spectrometry : selected reaction monitoring or high resolution full scan? / Lieve Dillen and Filip Cuyckens. |
| Record Nr. | UNINA-9910831188303321 |
| Hoboken, N.J., : John Wiley & Sons, c2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Mass spectrometry for drug discovery and drug development / / edited by Walter A. Korfmacher
| Mass spectrometry for drug discovery and drug development / / edited by Walter A. Korfmacher |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2013 |
| Descrizione fisica | 1 online resource (478 p.) |
| Disciplina | 615.1/9 |
| Altri autori (Persone) | KorfmacherWalter A |
| Collana | Wiley series on mass spectrometry |
| Soggetto topico |
Drugs - Analysis
Mass spectrometry |
| ISBN |
1-118-51615-X
1-283-91752-1 1-118-51612-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Overview of the various types of mass spectrometers that are used in drug discovery and drug development / Gerard Hopfgartner -- 2. Utility of high resolution mass spectrometry for new drug discovery applications / William Bart Emary and Nanyan Rena Zhang -- 3. Quantitative mass spectrometry considerations in a regulated environment / Mohammed Jemal and Yuan-Qing Xia -- 4. Mass spectrometry for quantitative in vitro ADME assays / Jun Zhang and Wilson Z. Shou -- 5. Metabolite identification using mass spectrometry in drug development / Natalia Penner, Joanna Zgoda-Pols, and Chandra Prakash -- 6. MS analysis of biological drugs, proteins, and peptides / Yi Du, John Mehl, and Pavlo Pristatsky -- 7. Characterization of impurities and degradation products in small molecule pharmaceuticals and biologics / Hui Wei, Guodong Chen and Adrienne A. Tymiak -- 8. Liquid extraction surface analysis (LESA) : a new mass spectrometry-based technique for ambient surface profiling / Dan Eikel and Jack Henion -- 9. MS applications in support of medicinal chemistry sciences / Maarten Honing, Benno Ingelse, and Birendray N. Pramanik -- 10. Imaging mass spectrometry of proteins and peptides / Michelle L. Reyzer and Richard M. Caprioli -- 11. Imaging mass spectrometry for drugs and metabolites / Stacey R. Oppenheimer -- 12. Screening reactive metabolites : role of liquid chromatography-high resolution mass spectrometry in combination with 'intelligent' data mining tools / Shuguang Ma and Swapan K. Chowdhury -- 13. Mass spectrometry of siRNA / Mark Cancilla and Mike Flanagan -- 14. Mass spectrometry for metabolomics / Petia Shipkova and Michael D. Reily -- 15. Quantitative analysis of peptides with mass spectrometry : selected reaction monitoring or high resolution full scan? / Lieve Dillen and Filip Cuyckens. |
| Record Nr. | UNINA-9910878073103321 |
| Hoboken, N.J., : John Wiley & Sons, c2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Mass spectrometry in sports drug testing [[electronic resource] ] : characterization of prohibited substances and doping control analytical assays / / Mario Thevis
| Mass spectrometry in sports drug testing [[electronic resource] ] : characterization of prohibited substances and doping control analytical assays / / Mario Thevis |
| Autore | Thevis Mario <1973-> |
| Pubbl/distr/stampa | Oxford, : Wiley, 2010 |
| Descrizione fisica | 1 online resource (377 p.) |
| Disciplina | 362.29 |
| Collana | Wiley-interscience series in mass spectrometry |
| Soggetto topico |
Doping in sports - Diagnosis
Mass spectrometry Drugs - Analysis |
| ISBN |
1-118-03514-3
1-282-70772-8 9786612707728 0-470-62663-1 0-470-62662-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
MASS SPECTROMETRY IN SPORTS DRUG TESTING: Characterization of Prohibited Substances and Doping Control Analytical Assays; CONTENTS; PREFACE; ACKNOWLEDGMENTS; 1: History of Sports Drug Testing; 2: Mass Spectrometry and the List of Prohibited Substances and Methods of Doping; 3: Structure Characterization of Low Molecular Weight Target Analytes-Electron Ionization; 4: Structure Characterization of Low Molecular Weight Target Analytes: Electrospray Ionization; 5: Structure Characterization of High Molecular Weight Target Analytes: Electrospray Ionization
6: Modern Mass Spectrometry-Based Analytical Assays7: Limitations and Perspectives of Mass Spectrometry-Based Procedures in Doping Control Analysis; INDEX |
| Record Nr. | UNINA-9910140814403321 |
Thevis Mario <1973->
|
||
| Oxford, : Wiley, 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Mass spectrometry in sports drug testing : characterization of prohibited substances and doping control analytical assays / / Mario Thevis
| Mass spectrometry in sports drug testing : characterization of prohibited substances and doping control analytical assays / / Mario Thevis |
| Autore | Thevis Mario <1973-> |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Oxford, : Wiley, 2010 |
| Descrizione fisica | 1 online resource (377 p.) |
| Disciplina | 362.29 |
| Collana | Wiley-interscience series in mass spectrometry |
| Soggetto topico |
Doping in sports - Diagnosis
Mass spectrometry Drugs - Analysis |
| ISBN |
1-118-03514-3
1-282-70772-8 9786612707728 0-470-62663-1 0-470-62662-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
MASS SPECTROMETRY IN SPORTS DRUG TESTING: Characterization of Prohibited Substances and Doping Control Analytical Assays; CONTENTS; PREFACE; ACKNOWLEDGMENTS; 1: History of Sports Drug Testing; 2: Mass Spectrometry and the List of Prohibited Substances and Methods of Doping; 3: Structure Characterization of Low Molecular Weight Target Analytes-Electron Ionization; 4: Structure Characterization of Low Molecular Weight Target Analytes: Electrospray Ionization; 5: Structure Characterization of High Molecular Weight Target Analytes: Electrospray Ionization
6: Modern Mass Spectrometry-Based Analytical Assays7: Limitations and Perspectives of Mass Spectrometry-Based Procedures in Doping Control Analysis; INDEX |
| Record Nr. | UNINA-9910824324003321 |
|
Thevis Mario <1973->
|
||
| Oxford, : Wiley, 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Membrane electrodes in drug-substances analysis / by Vasile V. Cosofret ; translation editor, J. D. R. Thomas
| Membrane electrodes in drug-substances analysis / by Vasile V. Cosofret ; translation editor, J. D. R. Thomas |
| Autore | Cosofret, Vasile V. |
| Edizione | [1st ed] |
| Pubbl/distr/stampa | Oxford : Pergamon Press, 1982 |
| Descrizione fisica | xvi, 362 p. : ill. ; 24 cm |
| Disciplina | 615.1901 |
| Soggetto topico |
Drugs - Analysis
Electrodes, Ion selective |
| ISBN | 0080262643 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNISALENTO-991003514639707536 |
|
Cosofret, Vasile V.
|
||
| Oxford : Pergamon Press, 1982 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. del Salento | ||
| ||
Method Development and Validation in Food and Pharmaceutical Analysis / / edited by In-Soo Yoon, Hyun-Jong Cho
| Method Development and Validation in Food and Pharmaceutical Analysis / / edited by In-Soo Yoon, Hyun-Jong Cho |
| Pubbl/distr/stampa | [Place of publication not identified] : , : MDPI - Multidisciplinary Digital Publishing Institute, , 2023 |
| Descrizione fisica | 1 online resource (322 pages) |
| Disciplina | 615.1901 |
| Soggetto topico | Drugs - Analysis |
| ISBN | 3-0365-6331-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | About the Editors ix -- Preface to "Method Development and Validation in Food and Pharmaceutical Analysis" . xi -- Mei-Jun Chu, Xin-Min Liu, Ning Yan, Feng-Zhong Wang, Yong-Mei Du and Zhong-Feng Zhang Partial Purification, Identification, and Quantitation of Antioxidants from Wild Rice (Zizania latifolia) Reprinted from: Molecules 2018, 23, 2782, doi:10.3390/molecules23112782 1 -- Song-Tao Dong, Ying Li, Hao-Tian Yang, Yin Wu, Ya-Jing Li, Cong-Yang Ding, Lu Meng, et al. An Accurate and Effective Method for Measuring Osimertinib by UPLC-TOF-MS and Its Pharmacokinetic Study in Rats Reprinted from: Molecules 2018, 23, 2894, doi:10.3390/molecules23112894 17 -- Stefan Fritzsche, Susan Billig, Robby Rynek, Ramarao Abburi, Elena Tarakhovskaya, Olga Leuner, Andrej Frolov, et al. Derivatization of Methylglyoxal for LC-ESI-MS Analysis-Stability and Relative Sensitivity of Different Derivatives Reprinted from: Molecules 2018, 23, 2994, doi:10.3390/molecules23112994 27 -- Shenghua Gao, Lili Meng, Chunjie Zhao, Tao Zhang, Pengcheng Qiu and Fuli Zhang Identification, Characterization and Quantification of Process-Related and Degradation Impurities in Lisdexamfetamine Dimesylate: Identifiction of Two New Compounds Reprinted from: Molecules 2018, 23, 3125, doi:10.3390/molecules23123125 47 -- Jia Zhou, Hao Cai, Sicong Tu, Yu Duan, Ke Pei, Yangyang Xu, Jing Liu, et al. Identification and Analysis of Compound Profiles of Sinisan Based on 'Individual Herb, Herb-Pair, Herbal Formula' before and after Processing Using UHPLC-Q-TOF/MS Coupled with Multiple Statistical Strategy Reprinted from: Molecules 2018, 23, 3128, doi:10.3390/molecules23123128 63 -- Seung-Sik Cho, Seung-Hui Song, Chul-Yung Choi, Kyung Mok Park, Jung-Hyun Shim and Dae-Hun Park Optimization of the Extraction Conditions and Biological Evaluation of Dendropanax morbifera H. Lev as an Anti-Hyperuricemic Source Reprinted from: Molecules 2018, 23, 3313, doi:10.3390/molecules23123313 79 -- Rui-ze Gong, Yan-hua Wang, Yu-fang Wang, Bao Chen, Kun Gao and Yin-shi Sun Simultaneous Determination of Nε-(carboxymethyl) Lysine and Nε-(carboxyethyl) Lysine in Different Sections of Antler Velvet after Various Processing Methods by UPLC-MS/MS Reprinted from: Molecules 2018, 23, 3316, doi:10.3390/molecules23123316 87 -- Seung-Yub Song, Seung-Hui Song, Min-Suk Bae and Seung-Sik Cho Phytochemical Constituents and the Evaluation Biological Effect of Cinnamomum yabunikkei H.Ohba Leaf Reprinted from: Molecules 2019, 24, 81, doi:10.3390/molecules24010081 . 101 -- Jung-hyun Shim, Jung-il Chae and Seung-sik Cho Identification and Extraction Optimization of Active Constituents in Citrus junos Seib ex TANAKA Peel and Its Biological Evaluation Reprinted from: Molecules 2019, 24, 680, doi:10.3390/molecules24040680 109 -- Wenrong Yao, Ying Guo, Xi Qin, Lei Yu, Xinchang Shi, Lan Liu, Yong Zhou, Jinpan Hu, Chunming Rao and Junzhi Wang Bioactivity Determination of a Therapeutic Recombinant Human Keratinocyte Growth Factor by a Validated Cell-based Bioassay Reprinted from: Molecules 2019, 24, 699, doi:10.3390/molecules24040699 119 -- Yin-Ling Ma, Feng Zhao, Jin-Tuo Yin, Cai-Juan Liang, Xiao-Li Niu, Zhi-Hong Qiu and Lan-Tong Zhang Two Approaches for Evaluating the Effects of Galangin on the Activities and mRNA Expression of Seven CYP450 Reprinted from: Molecules 2019, 24, 1171, doi:10.3390/molecules24061171 133 -- Rui-ze Gong, Yan-hua Wang, Kun Gao, Lei Zhang, Chang Liu, Ze-shuai Wang, Yu-fang Wang and Yin-shi Sun Quantification of Furosine (Nε-(2-Furoylmethyl)-L-lysine) in Different Parts of Velvet Antler with Various Processing Methods and Factors Affecting Its Formation Reprinted from: Molecules 2019, 24, 1255, doi:10.3390/molecules24071255 149 -- Shengwei Sun, Meijuan Liu, Jian He, Kunping Li, Xuguang Zhang and Guangling Yin Identification and Determination of Seven Phenolic Acids in Brazilian Green Propolis by UPLC-ESI-QTOF-MS and HPLC Reprinted from: Molecules 2019, 24, 1791, doi:10.3390/molecules24091791 163 -- You Jin Han, Bitna Kang, Eun-Ju Yang, Min-Koo Choi and Im-Sook Song Simultaneous Determination and Pharmacokinetic Characterization of Glycyrrhizin, Isoliquiritigenin, Liquiritigenin, and Liquiritin in Rat Plasma Following Oral Administration of Glycyrrhizae Radix Extract Reprinted from: Molecules 2019, 24, 1816, doi:10.3390/molecules24091816 177 -- Subindra Kazi Thapa, Mahesh Upadhyay, Tae Hwan Kim, Soyoung Shin, Sung-Joo Park and Beom Soo Shin Liquid Chromatography-Tandem Mass Spectrometry of Desoxo-Narchinol a and Its Pharmacokinetics and Oral Bioavailability in Rats and Mice Reprinted from: Molecules 2019, 24, 2037, doi:10.3390/molecules24112037 191 -- Eun-Sol Ha, Dong-Gyun Han, Seong-Wook Seo, Ji-Min Kim, Seon-Kwang Lee, Woo-Yong Sim, In-Soo Yoon, et al. A Simple HPLC Method for the Quantitative Determination of Silybin in Rat Plasma: Application to a Comparative Pharmacokinetic Study on Commercial Silymarin Products Reprinted from: Molecules 2019, 24, 2180, doi:10.3390/molecules24112180 203 -- Sojeong Jin, Ji-Hyeon Jeon, Sowon Lee, Woo Youl Kang, Sook Jin Seong, Young-Ran Yoon, Min-Koo Choi, et al. Detection of 13 Ginsenosides (Rb1, Rb2, Rc, Rd, Re, Rf, Rg1, Rg3, Rh2, F1, Compound K, 20(S)-Protopanaxadiol, and 20(S)-Protopanaxatriol) in Human Plasma and Application of the Analytical Method to Human Pharmacokinetic Studies Following Two Week-Repeated Administration of Red Ginseng Extract Reprinted from: Molecules 2019, 24, 2618, doi:10.3390/molecules24142618 211 --Mengqi Zhang, Xia Ren, Shijun Yue, Qing Zhao, Changlun Shao and Changyun Wang Simultaneous Quantification of Four Phenylethanoid Glycosides in Rat Plasma by UPLC-MS/MS and Its Application to a Pharmacokinetic Study of Acanthus Ilicifolius Herb Reprinted from: Molecules 2019, 24, 3117, doi:10.3390/molecules24173117 229 -- Ha-Na Oh, Dae-Hun Park, Ji-Yeon Park, Seung-Yub Song, Sung-Ho Lee, Goo Yoon, Hong-Seop Moon, et al. Tyrosinase Inhibition Antioxidant Effect and Cytotoxicity Studies of the Extracts of Cudrania tricuspidata Fruit Standardized in Chlorogenic Acid Reprinted from: Molecules 2019, 24, 3266, doi:10.3390/molecules24183266 241 -- Gregorio Carballo-Uicab, Jos´e E. Linares-Trejo, Gabriela Mellado-S´anchez, Carlos A. L ´opez-Morales, Marco Velasco-Vel´azquez, Lenin Pav ´on, Sergio Estrada-Parra, et al. Validation of a Cell Proliferation Assay to Assess the Potency of a Dialyzable Leukocyte Extract Intended for Batch Release Reprinted from: Molecules 2019, 24, 3426, doi:10.3390/molecules24193426 251 -- Joo Tae Hwang, Ki-Sun Park, Jin Ah Ryuk, Hye Jin Kim and Byoung Seob Ko Development of an Oriental Medicine Discrimination Method through Analysis of Steroidal Saponins in Dioscorea nipponica Makino and Their Anti-Osteosarcoma Effects Reprinted from: Molecules 2019, 24, 4022, doi:10.3390/molecules24224022 261 -- Seung-Hyun Jeong, Ji-Hun Jang, Hea-Young Cho and Yong-Bok Lee Pharmacokinetic Comparison of Epinastine Using Developed Human Plasma Assays Reprinted from: Molecules 2019, 25, 209, doi:10.3390/molecules25010209 277 -- Yoo-Seong Jeong, Minjeong Baek, Seungbeom Lee, Min-Soo Kim, Han-Joo Maeng, Jong-Hwa Lee, Young-Ger Suh, et al. Development and Validation of Analytical Method for SH-1242 in the Rat and Mouse Plasma by Liquid Chromatography/Tandem Mass Spectrometry Reprinted from: Molecules 2019, 25, 531, doi:10.3390/molecules25030531 297. |
| Record Nr. | UNINA-9910647214403321 |
| [Place of publication not identified] : , : MDPI - Multidisciplinary Digital Publishing Institute, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Method validation in pharmaceutical analysis : a guide to best practice. / / edited by Joachim Ermer and Phil Nethercote
| Method validation in pharmaceutical analysis : a guide to best practice. / / edited by Joachim Ermer and Phil Nethercote |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | Weinheim, Germany : , : Wiley-VCH Verlag, , 2015 |
| Descrizione fisica | 1 online resource (437 p.) |
| Disciplina | 615.1901 |
| Soggetto topico |
Drugs - Analysis
Methodology - Validity Pharmacology |
| ISBN |
1-5231-4402-5
3-527-67218-4 3-527-67220-6 3-527-67219-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Method Validation in Pharmaceutical Analysis; Contents; Foreword; List of Contributors; Chapter 1 Analytical Validation within the Pharmaceutical Lifecycle; 1.1 Development of Process and Analytical Validation Concepts; 1.2 Alignment between Process and Analytics: Three-Stage Approach; 1.3 Predefined Objectives: Analytical Target Profile; 1.4 Analytical Life Cycle; References; Chapter 2 Analytical Instrument Qualification; 2.1 Analytical Instrument and System Qualification; 2.1.1 Data Quality and Integrity in a GMP Environment; 2.1.1.1 Criteria for Quality Data
2.1.1.2 Regulatory Rationale for Qualified Analytical Instruments2.1.2 USP General Chapter ; 2.1.2.1 Data Quality Triangle; 2.1.2.2 Analytical Instrument Qualification Life Cycle: the Four Qs Model; 2.1.2.3 Risk-Based Classification of Apparatus, Instruments, and Systems; 2.1.2.4 Roles and Responsibilities for AIQ; 2.1.2.5 Software Validation for Group B and C Systems; 2.1.3 Enhancement of and Harmonization of a Risk-Based Approach to Instruments and Systems with GAMP Laboratory GPG Second Edition; 2.1.3.1 Increased Granularity of USP Groups 2.1.3.2 Clarification of AIQ Terminology2.1.3.3 A Continuum of Analytical Apparatus, Instruments, and Systems; 2.1.3.4 Mapping USP Instrument Groups to GAMP Software Categories; 2.1.3.5 Enhanced Data Quality Triangle; 2.1.4 Risk-Based Approaches to Analytical Instrument and System Qualification; 2.1.4.1 Expanded Instrument and System Categories; 2.2 Efficient and Economic HPLC Performance Qualification; 2.2.1 Introduction; 2.2.1.1 The Importance of Analytical Instrument Qualification; 2.2.1.2 Terms and Definitions; 2.2.1.3 Continuous Performance Qualification: More by Less 2.2.2 Development of the Revised OQ/PQ Parameters List2.2.3 Transfer of Modular Parameters into the Holistic Approach; 2.2.3.1 Autosampler; 2.2.3.2 Solvent Delivery System; 2.2.3.3 Detector; 2.2.4 OQ/PQ Data in Comparison with SST Data; 2.2.5 Control Charts; 2.2.6 General Procedure for Continuous PQ; 2.2.7 Concluding Remarks; Acknowledgment; Abbreviations; References; Chapter 3 Establishment of Measurement Requirements - Analytical Target Profile and Decision Rules; 3.1 Introduction; 3.2 Defining the Fitness for Intended Use; 3.3 Decision Rules 3.4 Overview of Process to Develop Requirements for Procedure Performance3.5 Decision Rules and Compliance; 3.6 Calculating Target Measurement Uncertainty; 3.6.1 Coverage Factor, k, and Data Distributions; 3.7 Types of Decision Rules; 3.7.1 Decision Rules That Use Guard Bands; 3.8 Target Measurement Uncertainty in the Analytical Target Profile; 3.8.1 Cost of Analysis; 3.9 Bias and Uncertainty in a Procedure; 3.10 ATP and Key Performance Indicators; 3.11 Measurement Uncertainty; 3.11.1 What Uncertainty Is; 3.11.2 Reporting Measurement Uncertainty; 3.11.3 How Uncertainty is Estimated 3.11.4 Uncertainty Contains All Sources of Random Variability |
| Record Nr. | UNINA-9910140505703321 |
| Weinheim, Germany : , : Wiley-VCH Verlag, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Method validation in pharmaceutical analysis : a guide to best practice. / / edited by Joachim Ermer and Phil Nethercote
| Method validation in pharmaceutical analysis : a guide to best practice. / / edited by Joachim Ermer and Phil Nethercote |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | Weinheim, Germany : , : Wiley-VCH Verlag, , 2015 |
| Descrizione fisica | 1 online resource (437 p.) |
| Disciplina | 615.1901 |
| Soggetto topico |
Drugs - Analysis
Methodology - Validity Pharmacology |
| ISBN |
1-5231-4402-5
3-527-67218-4 3-527-67220-6 3-527-67219-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Method Validation in Pharmaceutical Analysis; Contents; Foreword; List of Contributors; Chapter 1 Analytical Validation within the Pharmaceutical Lifecycle; 1.1 Development of Process and Analytical Validation Concepts; 1.2 Alignment between Process and Analytics: Three-Stage Approach; 1.3 Predefined Objectives: Analytical Target Profile; 1.4 Analytical Life Cycle; References; Chapter 2 Analytical Instrument Qualification; 2.1 Analytical Instrument and System Qualification; 2.1.1 Data Quality and Integrity in a GMP Environment; 2.1.1.1 Criteria for Quality Data
2.1.1.2 Regulatory Rationale for Qualified Analytical Instruments2.1.2 USP General Chapter ; 2.1.2.1 Data Quality Triangle; 2.1.2.2 Analytical Instrument Qualification Life Cycle: the Four Qs Model; 2.1.2.3 Risk-Based Classification of Apparatus, Instruments, and Systems; 2.1.2.4 Roles and Responsibilities for AIQ; 2.1.2.5 Software Validation for Group B and C Systems; 2.1.3 Enhancement of and Harmonization of a Risk-Based Approach to Instruments and Systems with GAMP Laboratory GPG Second Edition; 2.1.3.1 Increased Granularity of USP Groups 2.1.3.2 Clarification of AIQ Terminology2.1.3.3 A Continuum of Analytical Apparatus, Instruments, and Systems; 2.1.3.4 Mapping USP Instrument Groups to GAMP Software Categories; 2.1.3.5 Enhanced Data Quality Triangle; 2.1.4 Risk-Based Approaches to Analytical Instrument and System Qualification; 2.1.4.1 Expanded Instrument and System Categories; 2.2 Efficient and Economic HPLC Performance Qualification; 2.2.1 Introduction; 2.2.1.1 The Importance of Analytical Instrument Qualification; 2.2.1.2 Terms and Definitions; 2.2.1.3 Continuous Performance Qualification: More by Less 2.2.2 Development of the Revised OQ/PQ Parameters List2.2.3 Transfer of Modular Parameters into the Holistic Approach; 2.2.3.1 Autosampler; 2.2.3.2 Solvent Delivery System; 2.2.3.3 Detector; 2.2.4 OQ/PQ Data in Comparison with SST Data; 2.2.5 Control Charts; 2.2.6 General Procedure for Continuous PQ; 2.2.7 Concluding Remarks; Acknowledgment; Abbreviations; References; Chapter 3 Establishment of Measurement Requirements - Analytical Target Profile and Decision Rules; 3.1 Introduction; 3.2 Defining the Fitness for Intended Use; 3.3 Decision Rules 3.4 Overview of Process to Develop Requirements for Procedure Performance3.5 Decision Rules and Compliance; 3.6 Calculating Target Measurement Uncertainty; 3.6.1 Coverage Factor, k, and Data Distributions; 3.7 Types of Decision Rules; 3.7.1 Decision Rules That Use Guard Bands; 3.8 Target Measurement Uncertainty in the Analytical Target Profile; 3.8.1 Cost of Analysis; 3.9 Bias and Uncertainty in a Procedure; 3.10 ATP and Key Performance Indicators; 3.11 Measurement Uncertainty; 3.11.1 What Uncertainty Is; 3.11.2 Reporting Measurement Uncertainty; 3.11.3 How Uncertainty is Estimated 3.11.4 Uncertainty Contains All Sources of Random Variability |
| Record Nr. | UNINA-9910830145003321 |
| Weinheim, Germany : , : Wiley-VCH Verlag, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Microsampling in pharmaceutical bioanalysis / / editors, Patricia Zane, Gary T. Emmons
| Microsampling in pharmaceutical bioanalysis / / editors, Patricia Zane, Gary T. Emmons |
| Pubbl/distr/stampa | London, England : , : Future Science Ltd, , 2013 |
| Descrizione fisica | 1 online resource (145 pages) : color illustrations, photographs, tables |
| Disciplina | 615.1901 |
| Collana | Future Science |
| Soggetto topico |
Drugs - Analysis
Biomolecules - Analysis Microchemistry |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-909453-57-9
1-909453-58-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910464750503321 |
| London, England : , : Future Science Ltd, , 2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
