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Compendial Deferrals for USP41-NF36 1S

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Compendial Deferrals for USP41-NF36 1S Category Monograph Title Monograph Section Scientific Liaison {Emollient} Sodium Lauroyl Sarcosinate, {Emulsifying Agent} Sodium Lauroyl Revision USP AND NF EXCIPIENTS, LISTED BY CATEGORY PF 42(2) Pg. ONLINE Sarcosinate, {Chaotropic Agent} Hong Wang Introduction, 1. INTRODUCTION, 2. GENERAL QUALITY TESTS FOR INHALATION DRUG <5> INHALATION AND NASAL DRUG PRODUCTS GENERAL INFORMATION AND PRODUCTS, 3. GENERAL QUALITY TESTS FOR NASAL DRUG PRODUCTS, 4. Revision PRODUCT QUALITY TESTS PF 43(1) Pg. ONLINE DESCRIPTION OF PRODUCT QUALITY TESTS Kahkashan Zaidi Bendamustine Hydrochloride, Ropivacaine, Bortezomib, Sodium Lauroyl Sarcosinate, Epinastine Hydrochloride, Imipramine Hydrochloride, Carglumic Acid, Iloperidone, Benzphetamine Hydrochloride, Deferasirox, Eletriptan Hydrobromide, Milnacipran New DESCRIPTION AND SOLUBILITY PF 43(1) Pg. ONLINE Hydrochloride, Nebivolol Hydrochloride Feiwen Mao Title, INTRODUCTION/Introduction, PROCEDURE/Identification, PROCEDURE/Enumeration, PERFORMANCE TESTS/, CONTAMINANTS/Introduction, CONTAMINANTS/Listeria, ADDITIONAL REQUIREMENTS/Storage, ADDITIONAL New <64> PROBIOTIC TESTS - GENERAL PF 43(2) Pg. ONLINE REQUIREMENTS/Labeling, ??UNKNOWN??/Introduction Seong Jae Yoo Title, Introduction, INTRODUCTION, CHARACTERISTICS, IDENTIFICATION, TEST PROCEDURES, BIOLOGICAL TESTS, PHYSICOCHEMICAL TESTS, FUNCTIONALITY New <381> ELASTOMERIC CLOSURES FOR INJECTIONS PF 43(3) Pg. ONLINE TESTS, 1. INTRODUCTION, 2. SCOPE, 3. SPECIFICATIONS, 4. TEST METHODS Desmond Hunt Title, 1. INTRODUCTION, 2. SCOPE, 3. GENERAL TEST REQUIREMENTS, 4. PACKAGE <382> ELASTOMERIC CLOSURE FUNCTIONALITY IN INJECTABLE PHARMACEUTICAL INTEGRITY, 5. NEEDLE AND SPIKE ACCESS FUNCTIONALITY TESTS, 6. PLUNGER New PACKAGING/DELIVERY SYSTEMS PF 43(3) Pg. ONLINE FUNCTIONALITY TESTS, 7. TIP CAP AND NEEDLE SHIELD FUNCTIONALITY TESTS Desmond Hunt Introduction, INTRODUCTION, CLASSIFICATION OF RESIDUAL SOLVENTS BY RISK ASSESSMENT, METHODS FOR ESTABLISHING EXPOSURE LIMITS, OPTIONS FOR DESCRIBING LIMITS OF CLASS 2 RESIDUAL SOLVENTS, ANALYTICAL PROCEDURES, REPORTING LEVELS OF RESIDUAL SOLVENTS, LIMITS OF RESIDUAL SOLVENTS, IDENTIFICATION, CONTROL, AND QUANTIFICATION OF RESIDUAL SOLVENTS, GLOSSARY, APPENDIX 1. LIST, APPENDIX 2. ADDITIONAL BACKGROUND, APPENDIX 3. PROCEDURES FOR ESTABLISHING EXPOSURE LIMITS, 1. INTRODUCTION, 2. CLASSIFICATION OF RESIDUAL SOLVENTS BY RISK ASSESSMENT, 3. CONTROL STRATEGY, 4. LIMITS OF RESIDUAL SOLVENTS, 5. OPTIONS FOR DESCRIBING LIMITS OF CLASS 2 AND CLASS 3 RESIDUAL SOLVENTS, 6. REPORTING LEVELS OF RESIDUAL SOLVENTS, 7. IDENTIFICATION, CONTROL, AND QUANTIFICATION OF RESIDUAL SOLVENTS, 8. ANALYTICAL PROCEDURES FOR CLASS 1 AND CLASS 2 RESIDUAL SOLVENTS, 9. ANALYTICAL PROCEDURES FOR CLASS 3 RESIDUAL SOLVENTS, APPENDICES, CONTROL STRATEGY, OPTIONS FOR DESCRIBING LIMITS FOR RESIDUAL SOLVENTS, SCREENING FOR WATER-SOLUBLE ARTICLES, PROCEDURE A, PROCEDURE B, SCREENING FOR WATER-INSOLUBLE ARTICLES, CLASS 3 RESIDUAL SOLVENTS, LIMIT TESTS WHEN SOLVENTS LTBP ARE KNOWN, QUANTITATIVE TESTS, QUANTIFICATION FOR WATER-INSOLUBLE ARTICLES, PROCEDURE C, VERIFICATION AND VALIDATION, VERIFICATION OF COMPENDIAL PROCEDURES, VALIDATION OF Revision <467> RESIDUAL SOLVENTS PF 43(2) Pg. ONLINE ALTERNATIVE PROCEDURES Edmond Biba Title, INTRODUCTION/Introduction, PROCEDURE/Sample Preparation, PROCEDURE/qPCR Analysis, ADDITIONAL REQUIREMENTS/USP Reference Standards New <509> RESIDUAL DNA TESTING PF 42(5) Pg. ONLINE <11> Elena Curti TABLE OF CONTENTS, INTRODUCTION, A. DELIVERED-DOSE UNIFORMITYDELIVERED CONTENT UNIFORMITY, B. DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS, SPRAYS, AND POWDERS DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS <601> INHALATION AND NASAL DRUG PRODUCTS- AEROSOLS, SPRAYS, AND AND SPRAYS, C. AERODYNAMIC PARTICLE SIZE DISTRIBUTION-INHALATION Revision POWDERS--PERFORMANCE QUALITY TESTS PF 42(6) Pg. ONLINE AEROSOLS, SPRAYS, AND POWDERS Kahkashan Zaidi Revision <660> CONTAINERS -- GLASS PF 43(3) Pg. ONLINE Title, Introduction, SCOPE, DESCRIPTION, SPECIFIC TESTS Desmond Hunt Title, Introduction, 1. INTRODUCTION, 2. SCOPE, 3. ASSESSMENT PROCESS, 4. <665> POLYMERIC COMPONENTS AND SYSTEMS USED IN THE MANUFACTURING OF POLYMERIC MATERIALS OF CONSTRUCTION, 5. POLYMERIC COMPONENTS AND New PHARMACEUTICAL AND BIOPHARMACEUTICAL DRUG PRODUCTS PF 43(3) Pg. ONLINE SYSTEMS Desmond Hunt 2. QUALIFICATION OF NIR SPECTROMETERS, 3. PROCEDURE, 4. VALIDATION AND VERIFICATION, 1. INTRODUCTION, 2. QUALIFICATION OF NIR SPECTROMETERS, USP New <856> NEAR-INFRARED SPECTROSCOPY PF 42(2) Pg. ONLINE REFERENCE STANDARDS <11> Kahkashan Zaidi Introduction, QUALIFICATION OF RAMAN SPECTROMETERS, VALIDATION AND New <858> RAMAN SPECTROSCOPY PF 42(2) Pg. ONLINE VERIFICATION, Title, Introduction, PROCEDURE, VERIFICATION Kahkashan Zaidi <915> MEASUREMENT OF STRUCTURAL STRENGTH OF SEMISOLIDS BY New PENETROMETRY PF 43(2) Pg. ONLINE Title, INTRODUCTION, PROCEDURE, GLOSSARY Antonio Hernandez-Cardoso Title, BACKGROUND, BIOAVAILABILITY, BIOEQUIVALENCE, AND DISSOLUTION, <1090> ASSESSMENT OF DRUG PRODUCT PERFORMANCE--BIOAVAILABILITY, BIOEQUIVALENCE, DISSOLUTION AND IN VITRO PRODUCT PERFORMANCE, Revision BIOEQUIVALENCE, AND DISSOLUTION PF 42(4) Pg. ONLINE BIOWAIVER, APPENDIX William Brown INTRODUCTION, INSTRUMENTATION, METHOD VALIDATION, GLOSSARY, *No Head*, 1. THEORY, 2. TRANSMISSION, REFLECTION, AND TRANSFLECTION MODES, 3. FACTORS THAT AFFECT NIR SPECTRA, 4. PRETREATMENT OF NIR SPECTRAL DATA, 5. INSTRUMENTATION, 6. APPLICATIONS, 7. PROCEDURE VALIDATION, 8. APPENDIX: Revision <1119> NEAR-INFRARED SPECTROSCOPY PF 41(1) Pg. ONLINE GLOSSARY Kahkashan Zaidi Title, Introduction, 1. INTRODUCTION, 2. PERSONNEL TRAINING, 3. BUILDINGS AND FACILITIES, 4. EQUIPMENT AND COMPONENTS, 5. STANDARD OPERATING PROCEDURES, 6. PREPARATION ACTIVITIES, 7. RELEASE OF INVESTIGATIONAL AGENT/PREPARATION, 8. LABELING, 9. ESTABLISHING BEYOND-USE DATES, 10. <1168> COMPOUNDING FOR PHASE I INVESTIGATIONAL STUDIES PF 43(3) Pg. QUALITY ASSURANCE AND QUALITY CONTROL, 11. STORAGE, HANDLING, PACKAGING, New ONLINE AND TRANSPORT, 12. DOCUMENTATION, APPENDIX Jeanne Sun Title, INTRODUCTION, BACKGROUND, EXPERIMENTAL METHODS, SOLUBILITY New <1236> SOLUBILITY MEASUREMENTS PF 43(2) Pg. ONLINE MEASUREMENTS IN BIO-RELEVANT MEDIA, GLOSSARY, REFERENCES Antonio Hernandez-Cardoso Title, Introduction, 1. INTRODUCTION, 2. SCOPE, 3. DESCRIPTION OF ELASTOMERIC COMPONENTS IN PACKAGING SYSTEMS, 4. ELASTOMERIC COMPONENTS-MATERIALS <1381> ELASTOMERIC EVALUATION OF ELASTOMERIC COMPONENTS USED IN OF CONSTRUCTION, 5. ELASTOMERIC COMPONENTS-MANUFACTURING TECHNOLOGY New PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS PF 43(3) Pg. ONLINE AND STERILIZATION PROCEDURES, 6. TEST PROCEDURES Desmond Hunt Title, 1. INTRODUCTION, 2. EARLY PACKAGE DEVELOPMENT: CLOSURE <1382> ASSESSMENT OF ELASTOMERIC CLOSURE FUNCTIONALITY IN INJECTABLE FUNCTIONALITY ASSESSMENT, 3. ASSESSMENT OF THE FITNESS OF FUNCTIONALITY New PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS PF 43(3) Pg. ONLINE TEST FOR ITS INTENDED USE, 4. CONCLUSION Desmond Hunt <1467> RESIDUAL SOLVENTS- VERIFICATION OF COMPENDIAL PROCEDURES AND Title, Introduction, VERIFICATION OF COMPENDIAL PROCEDURES, VALIDATION OF New VALIDATION OF ALTERNATIVE PROCEDURES PF 43(2) Pg. ONLINE ALTERNATIVE PROCEDURES Edmond Biba Title, Introduction, PURPOSEINTRODUCTION, SCOPE, GLASS TYPES, FORMATION AND PROCESSINGOF MOLDED AND TUBULAR GLASS CONTAINERS, GLASS CONTAINER SOURCING, GLASS SURFACE CHEMISTRY, FACTORS THAT INFLUENCE INNER SURFACE <1660> EVALUATION OF THE INNER SURFACE DURABILITY OF GLASS CONTAINERS PF DURABILITY, EVALUATION OF THE INNER SURFACE DURABILITY, Revision 43(3) Pg. ONLINE CONCLUSIONSSUMMARY Desmond Hunt <1665> PLASTIC COMPONENTS AND SYSTEMS USED TO MANUFACTURE Title, 1. INTRODUCTION, 2. SCOPE, 3. GENERAL PRINCIPLES, 4. CHARACTERIZATION New PHARMACEUTICAL DRUG PRODUCTS PF 43(3) Pg. ONLINE PROCESS, 5. SAFETY QUALIFICATION, GLOSSARY Desmond Hunt Title, INTRODUCTION, QUALITATIVE AND QUANTITATIVE RAMAN MEASUREMENTS, FACTORS AFFECTING QUANTIFICATION, APPARATUS, QUALIFICATION AND VERIFICATION OF RAMAN SPECTROMETERS, METHOD VALIDATION, DEFINITION OF TERMS AND SYMBOLS, THEORY, SAMPLING FACTORS, SPECIALIZED TECHNIQUES, CALIBRATION, FACTORS THAT AFFECT MEASUREMENT PERFORMANCE, PROCEDURE Revision <1858> RAMAN SPECTROSCOPY - THEORY AND PRACTICE PF 40(6) Pg. ONLINE VALIDATION Kahkashan Zaidi New <1912> MEASUREMENT OF HARDNESS OF SEMISOLIDS PF 43(2) Pg. ONLINE Title, BACKGROUND, EXPERIMENTAL METHODS, GLOSSARY, REFERENCES Antonio Hernandez-Cardoso Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption <197K>, IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution <711>, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, IMPURITIES/Limit of Acamprosate Related Compound A, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acamprosate Calcium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acamprosate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards <11>/USP Acamprosate Related Compound New ACAMPROSATE DELAYED-RELEASE TABLETS PF 41(6) Pg. ONLINE B RS Heather Joyce IDENTIFICATION/B. Thin-Layer Chromatographic Identification Test <201>, Revision ACETAMINOPHEN TABLETS PF 42(3) Pg. ONLINE IDENTIFICATION/B., ASSAY/Procedure Clydewyn Anthony DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units <905>, PERFORMANCE TESTS/Deliverable Volume <698>, IMPURITIES/4-Aminophenol in Acetaminophen-
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  • Comparative Effects of Nebivolol and Atenolol on Blood Pressure and Insulin Sensitivity in Hypertensive Subjects with Type II Diabetes

    Comparative Effects of Nebivolol and Atenolol on Blood Pressure and Insulin Sensitivity in Hypertensive Subjects with Type II Diabetes

    Journal of Human Hypertension (1997) 11, 753–757 1997 Stockton Press. All rights reserved 0950-9240/97 $12.00 ORIGINAL ARTICLE Comparative effects of nebivolol and atenolol on blood pressure and insulin sensitivity in hypertensive subjects with type II diabetes R Fogari1, A Zoppi1, P Lazzari1, A Mugellini1, P Lusardi1, P Preti1, L Van Nueten2 and C Vertommen2 1Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy; 2Janssen Research Foundation, Beerse, Belgium The aim of this double-blind, parallel group study was to rate during the last 60 min of clamp and total glucose compare the effects of nebivolol and atenolol on blood requirements were evaluated. Nebivolol 5 mg once daily pressure (BP) and insulin sensitivity in hypertensive was of an equivalent efficacy as atenolol 50 mg once patients with type II, non-insulin dependent diabetes daily at reducing supine and standing systolic and dias- mellitus (NIDDM). After a 4-week run-in period on pla- tolic BP values. Neither b-blocker adversely affected cebo, 30 patients (14 males and 16 females) aged 43 to carbohydrate metabolism in terms of insulin sensitivity, 69 years, with stable NIDDM and mild to moderate whole body glucose utilization, HbA1c and 24-h urinary hypertension (DBP >95 and ,116 mm Hg) were random- C-peptide excretion. No significant changes in choles- ised to receive either nebivolol 5 mg or atenolol 50 mg, terol (total, high density and low density lipoprotein) both administered once daily for 6 months. At the end and triglycerides plasma levels were observed with both of the placebo and the active treatment periods, supine b-blockers.
  • Marrakesh Agreement Establishing the World Trade Organization

    Marrakesh Agreement Establishing the World Trade Organization

    No. 31874 Multilateral Marrakesh Agreement establishing the World Trade Organ ization (with final act, annexes and protocol). Concluded at Marrakesh on 15 April 1994 Authentic texts: English, French and Spanish. Registered by the Director-General of the World Trade Organization, acting on behalf of the Parties, on 1 June 1995. Multilat ral Accord de Marrakech instituant l©Organisation mondiale du commerce (avec acte final, annexes et protocole). Conclu Marrakech le 15 avril 1994 Textes authentiques : anglais, français et espagnol. Enregistré par le Directeur général de l'Organisation mondiale du com merce, agissant au nom des Parties, le 1er juin 1995. Vol. 1867, 1-31874 4_________United Nations — Treaty Series • Nations Unies — Recueil des Traités 1995 Table of contents Table des matières Indice [Volume 1867] FINAL ACT EMBODYING THE RESULTS OF THE URUGUAY ROUND OF MULTILATERAL TRADE NEGOTIATIONS ACTE FINAL REPRENANT LES RESULTATS DES NEGOCIATIONS COMMERCIALES MULTILATERALES DU CYCLE D©URUGUAY ACTA FINAL EN QUE SE INCORPOR N LOS RESULTADOS DE LA RONDA URUGUAY DE NEGOCIACIONES COMERCIALES MULTILATERALES SIGNATURES - SIGNATURES - FIRMAS MINISTERIAL DECISIONS, DECLARATIONS AND UNDERSTANDING DECISIONS, DECLARATIONS ET MEMORANDUM D©ACCORD MINISTERIELS DECISIONES, DECLARACIONES Y ENTEND MIENTO MINISTERIALES MARRAKESH AGREEMENT ESTABLISHING THE WORLD TRADE ORGANIZATION ACCORD DE MARRAKECH INSTITUANT L©ORGANISATION MONDIALE DU COMMERCE ACUERDO DE MARRAKECH POR EL QUE SE ESTABLECE LA ORGANIZACI N MUND1AL DEL COMERCIO ANNEX 1 ANNEXE 1 ANEXO 1 ANNEX