Statistical design and analysis in pharmaceutical science: validation, process controls, and stability
Saved in:
| Format: | Book |
|---|---|
| Language: | English |
| Published: |
New York u.a.
Dekker
1995
|
| Series: | Statistics
143 |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | VIII, 564 S. graph. Darst. |
| ISBN: | 0824793366 |
Staff View
MARC
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Record in the Search Index
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| adam_text | STATISTICAL DESIGN AND ANALYSIS PHARMACEUTICAL SCIENCE VALIDATION,
PROCESS CONTROLS, AND STABILITY EDITED BY SHEIN-CHUNG CHOW BRISTOL-MYERS
SQUIBB COMPANY PLAINSBORO, NEW JERSEY JEN-PEI LIU BERLEX LABORATORIES,
INC. WAYNE, NEW JERSEY MARCEL DEKKER, INC. NEW YORK * BASEL * HONG KONG
CONTENTS PREFACE 1. INTRODUCTION 1.1 1.2 1.3 1.4 1.5 1.6 2. ASSAY 2.1
2.2 2.3 2.4 2.5 2.6 3. ASSAY 3.1 3.2 BACKGROUND REGULATORY REQUIREMENTS
PHARMACEUTICAL VALIDATION QUALITY ASSURANCE STABILITY STUDY AIMS AND
STRUCTURE OF THE BOOK DEVELOPMENT INTRODUCTION CALIBRATION AND STANDARD
CURVE SIMPLE LINEAR REGRESSION STATISTICAL METHODS FOR CALIBRATION
WEIGHT AND MODEL SELECTIONS STATISTICAL CONSIDERATIONS VALIDATION
INTRODUCTION VALIDATION PARAMETERS III 1 4 8 12 18 23 25 25 26 27 36 47
55 71 71 72 VI CONTENTS 3.3 ASSAY ACCURACY 79 3.4 ASSAY PRECISION 89 3.5
ASSAY RUGGEDNESS 91 3.6 STATISTICAL DESIGNS 106 3.7 STATISTICAL
CONSIDERATIONS 108 4. SCALEUP DESIGN AND ANALYSIS 119 4.1 INTRODUCTION
119 4.2 EXPERIMENTAL DESIGNS 120 4.3 SCALEUP PROGRAM AND DESIGNS 134 4.4
SCALEUP ANALYSIS 140 4.5 DISCUSSION 146 5. USP TESTS AND SPECIFICATIONS
151 5.1 INTRODUCTION 151 5.2 SAMPLING PLAN AND ACCEPTANCE CRITERIA 152
5.3 PROBABILITY OF PASSING USP TEST 158 5.4 ACCEPTANCE LIMITS 170 5.5
IN-HOUSE SPECIFICATIONS 180 5.6 DISCUSSION 193 6. PROCESS VALIDATION 199
6.1 INTRODUCTION 199 6.2 PROCESS CONTROL AND VALIDATION 202 6.3 BASIC
CONSIDERATIONS 211 6.4 SAMPLING AND TESTING PLANS 214 6.5 ACCEPTANCE
LIMITS FOR PROCESS VALIDATION 217 6.6 DISCUSSION 227 7. QUALITY
ASSURANCE 235 7.1 INTRODUCTION 235 7.2 RAW MATERIALS INSPECTION 237 7.3
IN-PROCESS CONTROLS 240 7.4 RELEASE TARGETS 254 7.5 EXAMPLES 257 7.6
DISCUSSION 268 8. STABILITY STUDIES 271 8.1 INTRODUCTION 271 8.2
REGULATORY REQUIREMENTS 273 CONTENTS VII 8.3 STABILITY LOSS, OVERAGE,
AND SHELF LIFE 279 8.4 SHORT-TERM AND LONG-TERM STABILITY STUDIES 281
8.5 STATISTICAL CONSIDERATIONS 283 8.6 DISCUSSION 292 9. ACCELERATED
TESTING 295 295 297 301 312 316 321 10. DESIGN FOR LONG-TERM STABILITY
STUDIES 329 329 330 335 343 353 11. STABILITY ANALYSIS WITH FIXED
BATCHES 359 359 360 365 370 377 381 387 12. STABILITY ANALYSIS WITH
RANDOM BATCHES 391 12.1 INTRODUCTION 391 12.2 LINEAR REGRESSION WITH
RANDOM COEFFICIENTS 393 12.3 RANDOM BATCH EFFECT AND OTHER FIXED EFFECTS
394 12.4 SHELF LIFE ESTIMATION WITH RANDOM BATCHES 403 12.5 HLC METHOD
410 12.6 COMPARISION OF METHODS FOR MULTIPLE BATCHES 416 12.7 EXAMPLE
428 12.8 DISCUSSION 431 9.1 9.2 9.3 9.4 9.5 9.6 INTRODUCTION CHEMICAL
KINETIC REACTION STATISTICAL ANALYSIS AND PREDICTION EXAMINATIONS OF
MODEL ASSUMPTIONS EXAMPLE DISCUSSION DESIGN FOR LONG-TERM STABILITY
STUDIES 10.1 10.2 10.3 10.4 10.5 INTRODUCTION BASIC DESIGN
CONSIDERATIONS DESIGNS FOR STABILITY STUDIES DESIGN SELECTION DISCUSSION
STABILITY ANALYSIS WITH FIXED BATCHES 11.1 11.2 11.3 11.4 11.5 11.6 11.7
INTRODUCTION DRUG SHELF LIFE FOR A SINGLE BATCH PRELIMINARY TEST FOR
BATCH SIMILARITY MINIMUM APPROACH FOR MULTIPLE BATCHES MULTIPLE
COMPARISON PROCEDURE FOR POOLING BACHES EXAMPLE DISCUSSION VIII CONTENTS
APPENDIX A: STATISTICAL TABLES 435 A. 1 AREAS OF THE UPPER TAIL OF THE
STANDARD NORMAL DISTRIBUTION 436 A.2 UPPER QUANTILES OF A X 2
DISTRIBUTION 437 A.3 UPPER QUANTILES OF A CENTRAL T DISTRIBUTION 439 A.4
UPPER QUANTILES OF AN F DISTRIBUTION 440 A.5 UPPER QUANTILES OF THE
DISTRIBUTION OF THE WILCOXON-MANN-WHITNEY STATISTIC 448 A. 6 QUANTILES
OF THE WILCOXON SIGNED-RANK TEST STATISTIC 453 A. 7 TOLERANCE FACTORS
FOR THE DEGREES OF CONFIDENCE 1 - A 454 A.8 UPPER QUANTILES OF THE
STUDENTIZED RANGE DISTRIBUTION 455 A.9 UPPER QUANTILES OF THE DUNNETT S
T DISTRIBUTION: ONE-SIDED COMPARISONS WITH CONTROL 466 APPENDIX B: SAS
PROGRAMS 469 APPENDIX C: REGULATIONS 475 C.I CURRENT GOOD MANUFACTURING
PRACTICE 475 C.2 ICH GUIDELINE 506 C.3 1987 FDA STABILITY GUIDELINE 520
REFERENCES 549 INDEX 557
|
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| callnumber-first | R - Medicine |
| callnumber-label | RS122 |
| callnumber-raw | RS122.2 |
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| ctrlnum | (OCoLC)31604915 (DE-599)BVBBV010190957 |
| dewey-full | 615/.1/072 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615/.1/072 |
| dewey-search | 615/.1/072 |
| dewey-sort | 3615 11 272 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| format | Book |
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| illustrated | Illustrated |
| indexdate | 2024-07-09T17:48:08Z |
| institution | BVB |
| isbn | 0824793366 |
| language | English |
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| physical | VIII, 564 S. graph. Darst. |
| publishDate | 1995 |
| publishDateSearch | 1995 |
| publishDateSort | 1995 |
| publisher | Dekker |
| record_format | marc |
| series | Statistics |
| series2 | Statistics |
| spelling | Statistical design and analysis in pharmaceutical science validation, process controls, and stability ed. by Shein-Chung Chow ... New York u.a. Dekker 1995 VIII, 564 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Statistics 143 Drugs cabt Statistics cabt Experimental Design cabt Statistik Chemistry, Pharmaceutical methods Drug Stability Pharmaceutical Preparations standards Pharmacy Statistical methods Statistics as Topic methods Pharmazie (DE-588)4045705-9 gnd rswk-swf Statistik (DE-588)4056995-0 gnd rswk-swf Pharmazie (DE-588)4045705-9 s Statistik (DE-588)4056995-0 s DE-604 Chow, Shein-Chung Sonstige oth Statistics 143 (DE-604)BV000003265 143 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=006771156&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Statistical design and analysis in pharmaceutical science validation, process controls, and stability Statistics Drugs cabt Statistics cabt Experimental Design cabt Statistik Chemistry, Pharmaceutical methods Drug Stability Pharmaceutical Preparations standards Pharmacy Statistical methods Statistics as Topic methods Pharmazie (DE-588)4045705-9 gnd Statistik (DE-588)4056995-0 gnd |
| subject_GND | (DE-588)4045705-9 (DE-588)4056995-0 |
| title | Statistical design and analysis in pharmaceutical science validation, process controls, and stability |
| title_auth | Statistical design and analysis in pharmaceutical science validation, process controls, and stability |
| title_exact_search | Statistical design and analysis in pharmaceutical science validation, process controls, and stability |
| title_full | Statistical design and analysis in pharmaceutical science validation, process controls, and stability ed. by Shein-Chung Chow ... |
| title_fullStr | Statistical design and analysis in pharmaceutical science validation, process controls, and stability ed. by Shein-Chung Chow ... |
| title_full_unstemmed | Statistical design and analysis in pharmaceutical science validation, process controls, and stability ed. by Shein-Chung Chow ... |
| title_short | Statistical design and analysis in pharmaceutical science |
| title_sort | statistical design and analysis in pharmaceutical science validation process controls and stability |
| title_sub | validation, process controls, and stability |
| topic | Drugs cabt Statistics cabt Experimental Design cabt Statistik Chemistry, Pharmaceutical methods Drug Stability Pharmaceutical Preparations standards Pharmacy Statistical methods Statistics as Topic methods Pharmazie (DE-588)4045705-9 gnd Statistik (DE-588)4056995-0 gnd |
| topic_facet | Drugs Statistics Experimental Design Statistik Chemistry, Pharmaceutical methods Drug Stability Pharmaceutical Preparations standards Pharmacy Statistical methods Statistics as Topic methods Pharmazie |
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