Bioequivalence and statistics in clinical pharmacology. (2006)

• Record Type: Book
• Further Information: Note: Scott Patterson, Byron Jones.
• Other Names: Patterson, Scott D; Jones, Byron, 1951-
• Contents: DRUG DEVELOPMENT AND CLINICAL PHARMACOLOGY; Aims of This Book; Drug Development; Clinical Pharmacology; Statistics in Clinical Pharmacology; Structure of the Book; ; HISTORY AND REGULATION OF BIOEQUIVALENCE; When and How BE Studies Are Performed; Why Are BE Studies Performed?; Deciding When Formulations Are Bioequivalent; Potential Issues with TOST Bioequivalence; Current International Regulation; ; TESTING FOR AVERAGE BIOEQUIVALENCE; Background; Linear Model for 2 x 2 Data; Applying the TOST Procedure; Carry-over, Sequence, and Interaction Effects; Checking Assumptions Made about the Linear Model; Power and Sample Size for ABE in the 2 x 2 Design; Example Where Test and Reference Are Not ABE; Nonparametric Analysis; Some Practical Issues; ; BE STUDIES WITH MORE THAN TWO PERIODS; Background; Three-period Designs; Within-subject Variability; Robust Analyses for Three Period Designs; Four-Period Designs; Designs with More than Two Treatments; Nonparametric Analyses of Tmax; Technical Appendix: Efficiency; Tables of Data; ; DEALING WITH UNEXPECTED BE CHALLENGES; Restricted Maximum Likelihood Modelling; Failing BE and the DER Assessment; Simulation; Data-Based Simulation; Carry-Over; Optional Designs; Determining Trial Size; What Outliers are and How to Handle Their Data; Bayesian BE Assessment; Technical Appendix; ; THE FUTURE AND RECENT PAST OF BE TESTING; Brief History; Individual and Population BE; Scaled Average BE; ; CLINICAL PHARMACOLOGY SAFETY STUDIES; Background; First-time-in-humans; Sub-chronic Dosing Studies; Food-Effect Assessment and DDIs; Dose-Proportionality; Technical Appendix; ; QTC; Background; Modelling of QTc Data; Interpreting the QTc Modelling Findings; Design of a Thorough QTc Study in the Future; Technical Appendix; ; CLINICAL PHARMACOLOGY EFFICACY STUDIES; Background; Sub-chronic Dosing; Phase IIa and the Proof of Concept; Methodology Studies; ; POPULATION PHARMACOKINETICS; Population and Pharmacokinetics; Absolute and Relative Bioavailability; Age and Gender Pharmacokinetic Studies; Ethnicity; Liver Disease; Kidney Disease; Technical Appendix; ; Epilogue; Bibliography; Index
• Publisher Details: Boca Raton : Chapman & Hall/CRC
• Publication Date: 2006
• Extent: 1 online resource (xxi, 374 pages), illustrations
• Subjects: 615/.1; Clinical pharmacology; Drugs -- Therapeutic equivalency; Medical statistics; Pharmacology, Clinical; Therapeutic Equivalency; Statistics; Pharmacologie clinique; Médicaments -- Équivalence thérapeutique; Statistiques médicales; MEDICAL -- Drug Guides; MEDICAL -- Pharmacology; MEDICAL -- Pharmacy; MEDICAL -- Nursing -- Pharmacology; Clinical pharmacology; Drugs -- Therapeutic equivalency; Medical statistics; Electronic books
• Languages: English
• ISBNs: 1420034936; 9781420034936; 1584885300; 9781584885306
• Notes: Note: Includes bibliographical references (pages 335-370) and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.