| Monograph Title
|
Monograph Section
|
Scientific Liaison
|
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 33(4) Pg. 726 | MEASUREMENT PRINCIPLES AND VARIATION | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 33(4) Pg. 726 | APPENDIX B: PRECISION STUDY | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 33(4) Pg. 726 | APPENDIX C: EXAMPLES OF OUTLIER TESTS FOR ANALYTICAL DATA | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 33(4) Pg. 726 | APPENDIX D: COMPARISON OF METHODS -PRECISION | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 33(4) Pg. 726 | APPENDIX E: COMPARISON OF METHODSDETERMINING THE LARGEST ACCEPTABLE DIFFERENCE, delta, BETWEEN TWO METHODS | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 33(4) Pg. 726 | APPENDIX F: ADDITIONAL SOURCES OF INFORMATION | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 33(4) Pg. 726 | Tables | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 33(4) Pg. 726 | Prerequisite Laboratory Practices and Principles | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 33(4) Pg. 726 | Sampling Considerations | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 33(4) Pg. 726 | Appendix B: Precision Study | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 33(4) Pg. 726 | Dixon-Type Tests | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 33(4) Pg. 726 | Dixon-Type Tests | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 33(4) Pg. 726 | Sample Size | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 34(3) Pg. 764 | PREREQUISITE LABORATORY PRACTICES AND PRINCIPLES | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 34(3) Pg. 764 | PREREQUISITE LABORATORY PRACTICES AND PRINCIPLES | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 34(3) Pg. 764 | MEASUREMENT PRINCIPLES AND VARIATION | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 34(3) Pg. 764 | MEASUREMENT PRINCIPLES AND VARIATION | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 34(3) Pg. 764 | COMPARISON OF ANALYTICAL METHODS | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 34(3) Pg. 764 | APPENDIX B: PRECISION STUDY | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 34(3) Pg. 764 | APPENDIX B: PRECISION STUDY | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 34(3) Pg. 764 | APPENDIX D: COMPARISON OF METHODSPRECISION | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 34(3) Pg. 764 | APPENDIX E: COMPARISON OF METHODSDETERMINING THE LARGEST ACCEPTABLE DIFFERENCE, δ, BETWEEN TWO METHODS | Antonio Cardoso |
| <1010> ANALYTICAL DATA -- INTERPRETATION AND TREATMENT PF 34(3) Pg. 764 | APPENDIX F: ADDITIONAL SOURCES OF INFORMATION | Antonio Cardoso |
| <1078> GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 343 | BACKGROUND | Robert Lafaver |
| <1078> GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 343 | GENERAL GUIDANCE | Robert Lafaver |
| <1078> GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 343 | EXCIPIENT QUALITY SYSTEMS | Robert Lafaver |
| <1078> GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 343 | APPENDIX 1. DEFINITIONS | Robert Lafaver |
| <1078> GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 343 | APPENDIX 2. GENERAL AUDITING CONSIDERATIONS | Robert Lafaver |
| <1078> GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 343 | BACKGROUND | Robert Lafaver |
| <1078> GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 343 | INTRODUCTION | Robert Lafaver |
| <1078> GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 343 | GENERAL GUIDANCE | Robert Lafaver |
| <1078> GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 343 | QUALITY MANAGEMENT SYSTEM: EXCIPIENT QUALITY SYSTEMS | Robert Lafaver |
| <1078> GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 343 | MANAGEMENT RESPONSIBILITY | Robert Lafaver |
| <1078> GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 343 | RESOURCE MANAGEMENT | Robert Lafaver |
| <1078> GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 343 | PRODUCT REALIZATION | Robert Lafaver |
| <1078> GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 343 | MEASUREMENT, ANALYSIS, AND IMPROVEMENT | Robert Lafaver |
| <1078> GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 343 | APPENDIX 1. AUDITING CONSIDERATIONS | Robert Lafaver |
| <1078> GOOD MANUFACTURING PRACTICES FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 343 | APPENDIX 2. GLOSSARY | Robert Lafaver |
| <1195> SIGNIFICANT CHANGE GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 375 | Title | Robert Lafaver |
| <1195> SIGNIFICANT CHANGE GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 375 | BACKGROUND | Robert Lafaver |
| <1195> SIGNIFICANT CHANGE GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 375 | INTRODUCTION | Robert Lafaver |
| <1195> SIGNIFICANT CHANGE GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 375 | GENERAL GUIDANCE | Robert Lafaver |
| <1195> SIGNIFICANT CHANGE GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 375 | SIGNIFICANT CHANGE | Robert Lafaver |
| <1195> SIGNIFICANT CHANGE GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 375 | TYPES OF CHANGES | Robert Lafaver |
| <1195> SIGNIFICANT CHANGE GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 375 | REPORTING REQUIREMENTS | Robert Lafaver |
| <1195> SIGNIFICANT CHANGE GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 375 | GLOSSARY | Robert Lafaver |
| <1195> SIGNIFICANT CHANGE GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 375 | APPENDIX A: CHANGE LEVELS | Robert Lafaver |
| <1195> SIGNIFICANT CHANGE GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 375 | APPENDIX B: DECISION TREE | Robert Lafaver |
| <1195> SIGNIFICANT CHANGE GUIDE FOR BULK PHARMACEUTICAL EXCIPIENTS PF 34(2) Pg. 375 | APPENDIX C: IMPURITY PROFILE | Robert Lafaver |
| <1225> VALIDATION OF COMPENDIAL METHODS PF 34(3) Pg. 794 | VALIDATION | Horacio Pappa |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | Title | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | INTRODUCTION | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | DETECTION OF VIABLE VIRUSES | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | SAMPLE SELECTION OF AND PREPARATION FOR CELL- AND ANIMAL-BASED VIRUS DETECTION ASSAYS | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | CELL CULTURE-BASED VIRAL DETECTION METHODS | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | GENERAL REQUIREMENTS FOR CELL CULTUREBASED ASSAYS | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | ENDPOINTS FOR DETECTION OF VIRAL INFECTION | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | DESIGN OF CELL-BASED VIRAL ASSAYS | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | DETECTION OF RETROVIRUSES | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | ASSAYS DESIGNED TO DETECT SPECIFIC VIRUSES | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | IN VIVO METHODS | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | CONSIDERATIONS FOR VALIDATION, MATRIX QUALIFICATION, AND QUALITY CONTROL OF CELL- AND ANIMAL-BASED TEST SYSTEMS | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | DETECTION OF VIRAL COMPONENTS | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | DETECTION OF VIRAL ANTIGENS | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | DETECTION OF VIRAL NUCLEIC ACIDS | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | SAMPLE PREPARATION: SPECIAL CONSIDERATIONS FOR NUCLEIC ACID TESTING | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | DETECTION OF VIRAL GENOME VERSUS VIRAL TRANSCRIPTS | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | DETECTION OF ANTIBODIES TO VIRAL ANTIGENS | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | VIRAL STRUCTURE RELATIVE TO ANTIGENIC COMPOSITION AND SELECTION OF ANTIBODY ASSAY | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | GENERAL CONSIDERATIONS REGARDING SAMPLE PREPARATION FOR ANTIBODY DETECTION OF VIRAL ANTIGENS | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | ANTIBODY METHODS | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | GLOSSARY | Fouad Atouf |
| <1237> VIROLOGY TEST METHODS PF 34(2) Pg. 391 | APPENDIX: RELEVANT REGULATORY REFERENCES | Fouad Atouf |
| <191> IDENTIFICATION TESTS -- GENERAL PF 33(4) Pg. 719 | FiRadha Tirumalai paragraph of the chapter | Antonio Cardoso |
| <191> IDENTIFICATION TESTS -- GENERAL PF 34(2) Pg. 333 | Acetate | Antonio Cardoso |
| <191> IDENTIFICATION TESTS -- GENERAL PF 34(2) Pg. 333 | Ammonium | Antonio Cardoso |
| <2040> DISINTEGRATION AND DISSOLUTION OF DIETARY SUPPLEMENTS PF 34(2) Pg. 435 | RUPTURE TEST FOR SOFT GELATIN CAPSULES | Natalia Davydova |
| <271> READILY CARBONIZABLE SUBSTANCES TEST PF 33(6) Pg. 1258 | Title | Antonio Cardoso |
| <401> FATS AND FIXED OILS PF 34(3) Pg. 736 | ESTER VALUE | Hong Wang |
| <401> FATS AND FIXED OILS PF 34(3) Pg. 736 | HYDROXYL VALUE | Hong Wang |
| <401> FATS AND FIXED OILS PF 34(3) Pg. 736 | IODINE VALUE | Hong Wang |
| <401> FATS AND FIXED OILS PF 34(3) Pg. 736 | PEROXIDE VALUE | Hong Wang |
| <401> FATS AND FIXED OILS PF 34(3) Pg. 736 | SAPONIFICATION VALUE | Hong Wang |
| <401> FATS AND FIXED OILS PF 34(3) Pg. 736 | POLYUNSATURATED FATTY ACIDS DETERMINATION AND PROFILE | Curtis Phinney |
| <401> FATS AND FIXED OILS PF 34(3) Pg. 736 | TRACE METALS | Hong Wang |
| <401> FATS AND FIXED OILS PF 34(3) Pg. 736 | STEROL COMPOSITION | Hong Wang |
| <467> RESIDUAL SOLVENTS PF 34(3) Pg. 747 | IDENTIFICATION, CONTROL, AND QUANTIFICATION OF RESIDUAL SOLVENTS | Horacio Pappa |
| <467> RESIDUAL SOLVENTS PF 34(3) Pg. 747 | IDENTIFICATION, CONTROL, AND QUANTIFICATION OF RESIDUAL SOLVENTS | Horacio Pappa |
| <467> RESIDUAL SOLVENTS PF 34(3) Pg. 747 | IDENTIFICATION, CONTROL, AND QUANTIFICATION OF RESIDUAL SOLVENTS | Horacio Pappa |
| <467> RESIDUAL SOLVENTS PF 34(3) Pg. 747 | IDENTIFICATION, CONTROL, AND QUANTIFICATION OF RESIDUAL SOLVENTS | Horacio Pappa |
| <467> RESIDUAL SOLVENTS PF 34(3) Pg. 747 | IDENTIFICATION, CONTROL, AND QUANTIFICATION OF RESIDUAL SOLVENTS | Horacio Pappa |
| <467> RESIDUAL SOLVENTS PF 34(3) Pg. 747 | IDENTIFICATION, CONTROL, AND QUANTIFICATION OF RESIDUAL SOLVENTS | Horacio Pappa |
| <467> RESIDUAL SOLVENTS PF 34(3) Pg. 747 | Identification, control & Quantitation of residual solvents | |
| <621> CHROMATOGRAPHY PF 34(1) Pg. 152 | Everything except the Stationary Phase, Flow Rate(GC), and Flow Rate (Horacio PappaLC) of the SYSTEM SUITABILITY section | Horacio Pappa |
| <621> CHROMATOGRAPHY PF 34(3) Pg. 757 | SYSTEM SUITABILITY | Horacio Pappa |
| <661> CONTAINERS -- PLASTICS PF 34(2) Pg. 335 | INTRODUCTION | Desmond Hunt |
| <661> CONTAINERS -- PLASTICS PF 34(2) Pg. 335 | POLYETHYLENE CONTAINERS | Desmond Hunt |
| <661> CONTAINERS -- PLASTICS PF 34(2) Pg. 335 | POLYPROPYLENE CONTAINERS | Desmond Hunt |
| <671> CONTAINERS--PERFORMANCE TESTING PF 34(2) Pg. 337 | Introduction | Desmond Hunt |
| <671> CONTAINERS--PERFORMANCE TESTING PF 34(2) Pg. 337 | MOISTURE PERMEATION | Desmond Hunt |
| <671> CONTAINERS--PERFORMANCE TESTING PF 34(2) Pg. 337 | LIGHT TRANSMISSION TEST | Desmond Hunt |
| <731> LOSS ON DRYING PF 34(3) Pg. 760 | Title | Horacio Pappa |
