Generic drug product development: international regulatory requirements for bioequivalence
Saved in:
| Main Authors: | , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York
Informa Healthcare
2008
|
| Series: | drugs and pharmaceutical sciences
258 |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | XXI, 309 S. |
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Record in the Search Index
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| adam_text | GENERIC DRUG PRODUCT DEVELOPMENT BIOEQUIVALENCE ISSUES ISADORE KANFER
LEON SHARGEL RHODES UNIVERSITY APPLIED BIOPHARMACEUTICS GRAHAMSTOWN,
SOUTH AFRICA RALEIGH, NORTH CAROLINA, USA INFORMA HEALTHCARE NCWYORT
LONDON CONTENTS PREFACE HI CONTRIBUTORS IX 1.
INTRODUCTION*BIOEQUIVALENCE ISSUES 1 ISADORE KANFER AND LEON SHARGEL 2.
APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS (THE
ORANGE BOOK) 15 LOREN GELBER 3. PHARMACEUTICAL ALTERNATIVES:
CONSIDERATIONS FOR GENERIC SUBSTITUTION 31 RODERICK B. WALKER, ROGER K.
VERBEECK, AND ISADORE KANFER 4. PHARMACODYNAMIC MEASUREMENTS FOR
DETERMINATION OF BIOEQUIVALENCE 47 MANISH ISSAR, JEFFREY G. STARK, AND
LEON SHARGEL 5. BIOEQUIVALENCE USING CLINICAL ENDPOINT STUDIES 71
CHRISTOPHER HENDY 6. EVALUATION OF BIOEQUIVALENCE OF HIGHLY VARIABLE
DRUGS 97 LASZLO ENDRENYI AND LASZLO TOTHFALUSI 7. STATISTICAL
CONSIDERATIONS: ALTERNATE DESIGNS AND APPROACHES FOR BIOEQUIVALENCE
ASSESSMENTS 123 SANFORD BOLTON AND CHARLES BON 8. POPULATION
PHARMACOKINETIC APPROACHES FOR ASSESSING BIOEQUIVALENCE 143 PHILIPPE
COLUCCI, JEAN-FRANCOIS MARIE/; AND MURRAY P. DUCHARME 9. ROLE OF
METABOLITES IN BIOEQUIVALENCE ASSESSMENT 171 ANDRE JACKSON 10.
IMPLICATIONS OF CHIRALITY FOR THE ASSESSMENT OF BIOEQUIVALENCE 185 REZA
MEHVAR AND FAKHREDDIN JAMALI VII CONTENTS 11. EFFECT OF FOOD ON
BIOAVAILABILITY AND THE ASSESSMENT OF BIOEQUIVALENCE 207 KIM DALHOFF AND
ISADORE KANFER 12. BIOEQUIVALENCE ASSESSMENT OF ENDOGENOUS DRUG
SUBSTANCES: PHARMACOKINETICS AND STATISTICAL EVALUATION 233 PHILIPPE
COLUCCI, MARIKA PASTERNYK-DI MARCO, DIANE POTVIN, AND MURRAY P. DUCHARME
INDEX 257
|
| adam_txt |
GENERIC DRUG PRODUCT DEVELOPMENT BIOEQUIVALENCE ISSUES ISADORE KANFER
LEON SHARGEL RHODES UNIVERSITY APPLIED BIOPHARMACEUTICS GRAHAMSTOWN,
SOUTH AFRICA RALEIGH, NORTH CAROLINA, USA INFORMA HEALTHCARE NCWYORT
LONDON CONTENTS PREFACE HI CONTRIBUTORS IX 1.
INTRODUCTION*BIOEQUIVALENCE ISSUES 1 ISADORE KANFER AND LEON SHARGEL 2.
APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS (THE
ORANGE BOOK) 15 LOREN GELBER 3. PHARMACEUTICAL ALTERNATIVES:
CONSIDERATIONS FOR GENERIC SUBSTITUTION 31 RODERICK B. WALKER, ROGER K.
VERBEECK, AND ISADORE KANFER 4. PHARMACODYNAMIC MEASUREMENTS FOR
DETERMINATION OF BIOEQUIVALENCE 47 MANISH ISSAR, JEFFREY G. STARK, AND
LEON SHARGEL 5. BIOEQUIVALENCE USING CLINICAL ENDPOINT STUDIES 71
CHRISTOPHER HENDY 6. EVALUATION OF BIOEQUIVALENCE OF HIGHLY VARIABLE
DRUGS 97 LASZLO ENDRENYI AND LASZLO TOTHFALUSI 7. STATISTICAL
CONSIDERATIONS: ALTERNATE DESIGNS AND APPROACHES FOR BIOEQUIVALENCE
ASSESSMENTS 123 SANFORD BOLTON AND CHARLES BON 8. POPULATION
PHARMACOKINETIC APPROACHES FOR ASSESSING BIOEQUIVALENCE 143 PHILIPPE
COLUCCI, JEAN-FRANCOIS MARIE/; AND MURRAY P. DUCHARME 9. ROLE OF
METABOLITES IN BIOEQUIVALENCE ASSESSMENT 171 ANDRE' JACKSON 10.
IMPLICATIONS OF CHIRALITY FOR THE ASSESSMENT OF BIOEQUIVALENCE 185 REZA
MEHVAR AND FAKHREDDIN JAMALI VII CONTENTS 11. EFFECT OF FOOD ON
BIOAVAILABILITY AND THE ASSESSMENT OF BIOEQUIVALENCE 207 KIM DALHOFF AND
ISADORE KANFER 12. BIOEQUIVALENCE ASSESSMENT OF ENDOGENOUS DRUG
SUBSTANCES: PHARMACOKINETICS AND STATISTICAL EVALUATION 233 PHILIPPE
COLUCCI, MARIKA PASTERNYK-DI MARCO, DIANE POTVIN, AND MURRAY P. DUCHARME
INDEX 257 |
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| spelling | Kanfer, Isadore Verfasser aut Generic drug product development international regulatory requirements for bioequivalence ed. by Isadore Kanfer ; Leon Shargel New York Informa Healthcare 2008 XXI, 309 S. txt rdacontent n rdamedia nc rdacarrier drugs and pharmaceutical sciences 258 Shargel, Leon Verfasser aut drugs and pharmaceutical sciences 258 (DE-604)BV000002008 258 GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=015754238&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Kanfer, Isadore Shargel, Leon Generic drug product development international regulatory requirements for bioequivalence drugs and pharmaceutical sciences |
| title | Generic drug product development international regulatory requirements for bioequivalence |
| title_auth | Generic drug product development international regulatory requirements for bioequivalence |
| title_exact_search | Generic drug product development international regulatory requirements for bioequivalence |
| title_exact_search_txtP | Generic drug product development international regulatory requirements for bioequivalence |
| title_full | Generic drug product development international regulatory requirements for bioequivalence ed. by Isadore Kanfer ; Leon Shargel |
| title_fullStr | Generic drug product development international regulatory requirements for bioequivalence ed. by Isadore Kanfer ; Leon Shargel |
| title_full_unstemmed | Generic drug product development international regulatory requirements for bioequivalence ed. by Isadore Kanfer ; Leon Shargel |
| title_short | Generic drug product development |
| title_sort | generic drug product development international regulatory requirements for bioequivalence |
| title_sub | international regulatory requirements for bioequivalence |
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