Robustness of analytical chemical methods and pharmaceutical technological products:
Saved in:
| Format: | Book |
|---|---|
| Language: | English |
| Published: |
Amsterdam u.a.
Elsevier
1996
|
| Series: | Data handling in science and technology
19 |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | XIV, 346 S. graph. Darst. |
| ISBN: | 0444897097 |
Staff View
MARC
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| 245 | 1 | 0 | |a Robustness of analytical chemical methods and pharmaceutical technological products |c ed. by Margriet M. W. B. Hendriks ... |
| 264 | 1 | |a Amsterdam u.a. |b Elsevier |c 1996 | |
| 300 | |a XIV, 346 S. |b graph. Darst. | ||
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| 337 | |b n |2 rdamedia | ||
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| 490 | 1 | |a Data handling in science and technology |v 19 | |
| 650 | 4 | |a Chemometrics | |
| 650 | 4 | |a Data Interpretation, Statistical | |
| 650 | 4 | |a Drug Compounding | |
| 650 | 4 | |a Drug Design | |
| 650 | 4 | |a Drugs |x Analysis |x Statistical methods | |
| 650 | 4 | |a Pharmaceutical Preparations |x analysis | |
| 650 | 4 | |a Pharmaceutical technology |x Statistical methods | |
| 650 | 4 | |a Quality Control | |
| 650 | 4 | |a Robust statistics | |
| 700 | 1 | |a Hendriks, Margriet M. W. B. |e Sonstige |4 oth | |
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Record in the Search Index
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| adam_text | DATA HANDLING IN SCIENCE AND TECHNOLOGY * VOLUME 19 ADVISORY EDITORS:
B.G.M. VANDEGINSTE AND S.C. RUTAN ROBUSTNESS OF ANALYTICAL CHEMICAL
METHODS AND PHARMACEUTICAL TECHNOLOGICAL PRODUCTS EDITED BY MARGRIET
M.W.B. HENDRIKS AGRICULTURAL MATHEMATICS GROUP, P.O. BOX 100, 6700 AC
WAGENINGEN,THE NETHERLANDS JAN H. DE BOER GASUNIE RESEARCH, P.O. BOX 19,
9700 MA GRONINGEN, THE NETHERLANDS AGE K. SMILDE LABORATORY FOR
ANALYTICAL CHEMISTRY, UNIVERSITY OF AMSTERDAM NIEUWE ACHTERGRACHT 166,
1018 VW AMSTERDAM, THE NETHERLANDS 1996 ELSEVIER AMSTERDAM * LAUSANNE *
NEW YORK * OXFORD * SHANNON * TOKYO TABLE OF CONTENTS CHAPTER 1 GENERAL
INTRODUCTION TO ROBUSTNESS 1 1.1 INTRODUCTION 1 1.2 APPLICATION AREAS
AND RELATED ROBUSTNESS QUESTIONS 2 1.2.1 PHARMACEUTICAL FORMULATIONS 2
1.2.2 ANALYTICAL CHEMICAL METHODS 3 1.3 STATISTICAL METHODOLOGY 4 1.3.1
TAGUCHI METHOD 4 1.3.2 RSM AND EXPERIMENTAL DESIGN 5 1.3.3 SEQUENTIAL OR
SIMULTANEOUS OPTIMIZATION 6 1.3.4 MULTICRITERIA OPTIMIZATION 7 1.3.5
ROBUSTNESS CRITERIA 7 1.4 RECOMMENDED READING PATHS 8 REFERENCES 9
CHAPTER 2 STABILITY AND RESPONSE SURFACE METHODOLOGY 11 2.1 INTRODUCTION
11 2.1.1 EXAMPLE 13 2.2 AN OVERVIEW OF RESPONSE SURFACE METHODOLOGY 15
2.2.1 FIRST-ORDER DESIGNS 18 2.2.2 ADDING CENTER POINTS 24 2.2.3
SECOND-ORDER DESIGNS 25 2.2.4 OPTIMAL DESIGNS 33 2.2.5 OTHER
SECOND-ORDER DESIGNS 34 2.2.6 INTERIM SUMMARY 35 2.3 ROBUST DESIGN AND
RESPONSE SURFACE METHODOLOGY 35 2.3.1 RESPONSE SURFACE MODELING OF THE
MEAN AND STANDARD DEVIATION 37 2.3.2 ANALYZING THE MEAN AND STANDARD
DEVIATION RESPONSE SURFACES 39 2.3.3 EXPERIMENTAL DESIGN WITH
ENVIRONMENTAL VARIABLES 41 VN VNI CONTENTS 2.3.4 ANALYSIS OF
EXPERIMENTAL DESIGNS WITH ENVIRONMENTAL VARIABLES 47 2.3.5 EXAMPLE 53
2.4 SPLIT-PLOT DESIGNS FOR ROBUST DESIGN 57 2.4.1 OVERVIEW OF SPLIT-PLOT
DESIGNS 59 2.4.2 PRECISION OF SPLIT-PLOT DESIGNS 69 2.4.3 VARIANTS OF
SPLIT-PLOT DESIGNS 69 2.4.4 ANALYSIS OF SPLIT-PLOT DESIGNS FOR ROBUST
EXPERIMENTATION 70 2.5 CONCLUSIONS 73 ACKNOWLEDGEMENTS 75 REFERENCES 75
CHAPTER 3 REVIEW OF THE USE OF ROBUSTNESS AND RUGGEDNESS IN ANALYTICAL
CHEMISTRY 79 3.1 INTRODUCTION 79 3.2 PLACE OF RUGGEDNESS TESTING IN
METHOD VALIDATION 80 3.3 DEFINITIONS OF RUGGEDNESS 83 3.4 RUGGEDNESS
TESTING OF PROCEDURE RELATED FACTORS 85 3.4.1 THE STEPS OF A RUGGEDNESS
TEST 85 3.4.2 SELECTION OF THE FACTORS 86 3.4.3 SELECTION OF THE LEVELS
OF THE FACTORS 88 3.4.4 SELECTION OF THE EXPERIMENTAL DESIGN 92 3.4.5
EXPERIMENTAL PART OF THE RUGGEDNESS TEST 112 3.4.6 ANALYSIS OF THE
RESULTS 114 3.4.7 STATISTICAL ANALYSIS OF THE RESULTS 115 3.4.8 USING
PREDEFINED VALUES TO IDENTIFY CHEMICALLY RELEVANT FACTORS 124 3.4.9 CASE
STUDIES 127 3.4.10 EXPERT SYSTEMS AND SOFTWARE PACKAGES FOR RUGGEDNESS
TESTING 138 3.5 RUGGEDNESS TESTING OF NON-PROCEDURE RELATED FACTORS: THE
USE OF NESTED DESIGNS 138 3.6 CONCLUSIONS 143 ACKNOWLEDGEMENTS 144
REFERENCES 145 CONTENTS IX CHAPTER 4 ROBUSTNESS CRITERIA; INCORPORATING
ROBUSTNESS EXPLICITLY IN OPTIMIZATION PROCEDURES UTILIZING MULTICRITERIA
METHODS 149 4.1 INTRODUCTION 149 4.2 A BRIEF INTRODUCTION TO THE TAGUCHI
METHODS 150 4.2.1 INTRODUCTION 150 4.2.2 THE LOSS FUNCTION 151 4.2.3
OFF-LINE QUALITY CONTROL 154 4.2.4 ORTHOGONAL ARRAYS 156 4.3 THE
ROBUSTNESS CRITERIA 157 4.3.1 INTRODUCTION 157 4.3.2 THE
VARIANCE/COVARIANCE STRUCTURE OF A MIXTURE 159 4.3.3 GENERAL ASPECTS OF
THE ROBUSTNESS CRITERIA 166 4.3.4 THE JONES METHOD 166 4.3.5 THE
WEIGHTED JONES METHOD 169 4.3.6 THE PROJECTED VARIANCE METHOD 170 4.3.7
THE ROBUSTNESS COEFFICIENT 172 4.4 MULTICRITERIA DECISION MAKING 175
4.4.1 INTRODUCTION 175 4.4.2 THEORY OF MCDM 180 4.5 THE ROBUSTNESS
COEFFICIENT APPLIED IN A MCDM STRATEGY183 4.5.1 INTRODUCTION 183 4.5.2
THEORY 183 4.5.3 EXPERIMENTAL 184 4.5.4 RESULTS AND DISCUSSION 185
REFERENCES 189 CHAPTER 5 RUGGEDNESS TESTS FOR ANALYTICAL CHEMISTRY 191
5.1 INTRODUCTION 191 5.1.1 DESIGNING A PROTOCOL FOR METHOD VALIDATION
192 5.1.2 SUMMARY OF THE ROLE OF A RUGGEDNESS TEST IN A METHOD
VALIDATION PROGRAM 196 5.2 SELECTION OF FACTORS TO TEST 197 5.2.1
SELECTION OF THE NUMBER OF LEVELS AT WHICH TO TEST A FACTOR 198 CONTENTS
5.2.2 SELECTION OF FACTORS FOR HPLC METHODS 198 5.2.3 SELECTION OF
FACTORS FOR OTHER ANALYTICAL METHODS 201 5.3 SELECTION OF EXPERIMENTAL
DESIGNS 202 5.3.1 FACTORIAL DESIGNS 203 5.3.2 STAR DESIGNS 209 5.3.3
CENTRAL COMPOSITE DESIGNS 211 5.3.4 BOX-BEHNKEN DESIGNS 211 5.3.5
MATCHING THE RUGGEDNESS TEST TO AN EFFICIENT DESIGN 212 5.4 TREATMENT OF
RESULTS 214 5.4.1 MEASUREMENTS FOR A HPLC STUDY 214 5.4.2 TREATMENT OF
THE RESULTS FROM THE RUGGEDNESS STUDY 216 5.4.3 CONFOUNDING EFFECTS IN
FRACTIONAL FACTORIAL DESIGNS 217 5.5 EXAMPLE CASE STUDIES 219 5.5.1 THE
APPLICATION OF A RUGGEDNESS TEST TO THE ASSAY OF ASPIRIN AND ITS MAJOR
DEGRADATION PRODUCT, SALICYLIC ACID 219 5.5.2 THE APPLICATION OF A
RUGGEDNESS TEST TO THE ASSAY OF SALBUTAMOL AND ITS MAJOR DEGRADATION
PRODUCT, AH4045 226 5.6 CONCLUSIONS 230 REFERENCES 230 CHAPTER 6
STABILIZING A TLC SEPARATION ILLUSTRATED BY A MIXTURE OF SEVERAL STREET
DRUGS 233 6.1 INTRODUCTION 233 6.2 THEORY 233 6.2.1 THIN LAYER
CHROMATOGRAPHY 233 6.2.2 SEPARATION PROBLEM 235 6.2.3 SELECTION OF
MOBILE PHASES 236 6.2.4 INFLUENCE OF TEMPERATURE AND RELATIVE HUMIDITY
238 6.2.5 OPTIMIZATION 240 6.2.6 THE TAGUCHI APPROACH TO ROBUSTNESS 242
6.2.7 APPLICATION OF A PARAMETER DESIGN IN OPTIMIZATION 243 6.2.8
GENERALIZATION OF PARAMETER DESIGN TOWARDS RESPONSE SURFACE METHODOLOGY
(RSM) 245 6.2.9 CONSTRUCTION OF EXPERIMENTAL DESIGNS 246 6.2.10
SELECTION OF THE DEPENDENT VARIABLE. 248 6.2.11 CONSTRUCTION OF MODELS
FOR THE DEPENDENT VARIABLES 250 CONTENTS XI 6.2.12 SELECTION CRITERIA
FOR MODELS 251 6.2.13 SELECTION OF OPTIMIZATION CRITERIA. 252 6.3
EXPERIMENTAL 254 6.3.1 MATERIALS AND METHODS 6.3.2 SOFTWARE 254 6.4
RESULTS 254 6.4.1 INTRODUCTION 254 6.4.2 BOX COX TRANSFORMATION 254
6.4.3 SELECTION OF MODELS 257 6.4.4 CHROMATOGRAPHIC AND EMPIRICAL MODELS
258 6.4.5 DETERMINATION OF A SOLVENT WITH A HIGH MINIMUM RESOLUTION 258
6.4.6 DETERMINATION OF A SOLVENT COMPOSITION WITH A ROBUST MINIMUM
RESOLUTION 259 6.5 CONCLUSIONS 262 REFERENCES 263 CHAPTER 7 ROBUSTNESS
OF LIQUID-LIQUID EXTRACTION OF DRUGS FROM BIOLOGICAL SAMPLES 265 7.1
INTRODUCTION 265 7.2 THEORY 268 7.2.1 LIQUID-LIQUID EXTRACTION
OPTIMISATION THEORY 268 7.2.2 OPTIMISATION CRITERIA 270 7.3 EXPERIMENTAL
281 7.3.1 VALIDATION OF ROBUSTNESS CRITERIA BY MEANS OF A COMPARISON
WITH A SIMULATION EXPERIMENT 281 7.3.2 SELECTION OF SOLVENTS 284 7.3.3
THE EXTRACTION OF A GROUP OF SULPHONAMIDES FROM PLASMA 286 7.4 RESULTS
AND DISCUSSION 288 7.4.1 VALIDATION OF ROBUSTNESS CRITERIA BY MEANS OF A
COMPARISON WITH A SIMULATION EXPERIMENT 288 7.4.2 THE EXTRACTION OF A
GROUP OF SULPHONAMIDES 295 7.5 CONCLUSIONS 304 ACKNOWLEDGEMENTS 305
REFERENCES 305 XII CONTENTS CHAPTER 8 THE USE OF A FACTORIAL DESIGN TO
EVALUATE THE PHYSICAL STABILITY OF TABLETS AFTER STORAGE UNDER TROPICAL
CONDITIONS 309 8.1 INTRODUCTION 309 8.1.1 THE USE OF EXPERIMENTAL
DESIGNS IN TABLET FORMULATION 310 8.1.2 THE USE OF FACTORIAL DESIGNS IN
PHYSICAL TABLET STABILITY STUDIES 311 8.2 THE USE OF THE RELATIVE CHANGE
IN TABLET PARAMETERS IN A FACTORIAL DESIGN 312 8.2.1 PLANNING OF THE
DESIGN 313 8.2.2 TABLETTING, STORAGE AND MEASUREMENTS 314 8.2.3 RESULTS
314 8.2.4 CONCLUSIONS 325 8.3 SELECTION OF EXCIPIENTS SUITABLE FOR USE
IN TROPICAL COUNTRIES 328 8.3.1 PLANNING OF THE DESIGN 328 8.3.2
TABLETTING, STORAGE AND MEASUREMENTS 330 8.3.3 RESULTS 331 8.3.4
CONCLUSIONS 340 REFERENCES 340
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| illustrated | Illustrated |
| indexdate | 2024-07-09T18:06:10Z |
| institution | BVB |
| isbn | 0444897097 |
| language | English |
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| physical | XIV, 346 S. graph. Darst. |
| publishDate | 1996 |
| publishDateSearch | 1996 |
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| publisher | Elsevier |
| record_format | marc |
| series | Data handling in science and technology |
| series2 | Data handling in science and technology |
| spelling | Robustness of analytical chemical methods and pharmaceutical technological products ed. by Margriet M. W. B. Hendriks ... Amsterdam u.a. Elsevier 1996 XIV, 346 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Data handling in science and technology 19 Chemometrics Data Interpretation, Statistical Drug Compounding Drug Design Drugs Analysis Statistical methods Pharmaceutical Preparations analysis Pharmaceutical technology Statistical methods Quality Control Robust statistics Hendriks, Margriet M. W. B. Sonstige oth Data handling in science and technology 19 (DE-604)BV002802448 19 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=007534754&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Robustness of analytical chemical methods and pharmaceutical technological products Data handling in science and technology Chemometrics Data Interpretation, Statistical Drug Compounding Drug Design Drugs Analysis Statistical methods Pharmaceutical Preparations analysis Pharmaceutical technology Statistical methods Quality Control Robust statistics |
| title | Robustness of analytical chemical methods and pharmaceutical technological products |
| title_auth | Robustness of analytical chemical methods and pharmaceutical technological products |
| title_exact_search | Robustness of analytical chemical methods and pharmaceutical technological products |
| title_full | Robustness of analytical chemical methods and pharmaceutical technological products ed. by Margriet M. W. B. Hendriks ... |
| title_fullStr | Robustness of analytical chemical methods and pharmaceutical technological products ed. by Margriet M. W. B. Hendriks ... |
| title_full_unstemmed | Robustness of analytical chemical methods and pharmaceutical technological products ed. by Margriet M. W. B. Hendriks ... |
| title_short | Robustness of analytical chemical methods and pharmaceutical technological products |
| title_sort | robustness of analytical chemical methods and pharmaceutical technological products |
| topic | Chemometrics Data Interpretation, Statistical Drug Compounding Drug Design Drugs Analysis Statistical methods Pharmaceutical Preparations analysis Pharmaceutical technology Statistical methods Quality Control Robust statistics |
| topic_facet | Chemometrics Data Interpretation, Statistical Drug Compounding Drug Design Drugs Analysis Statistical methods Pharmaceutical Preparations analysis Pharmaceutical technology Statistical methods Quality Control Robust statistics |
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