Applied biopharmaceutics & pharmacokinetics:
Gespeichert in:
| Hauptverfasser: | , , |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
New York [u.a.]
McGraw-Hill
2012
|
| Ausgabe: | 6. ed. |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XVIII, 811 S. Ill., zahlr. graph. Darst. |
| ISBN: | 9780071603935 007160393X |
Internformat
MARC
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| 008 | 120302s2012 ad|| |||| 00||| eng d | ||
| 020 | |a 9780071603935 |9 978-0-07-160393-5 | ||
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| 100 | 1 | |a Shargel, Leon |d 1941- |e Verfasser |0 (DE-588)1145926010 |4 aut | |
| 245 | 1 | 0 | |a Applied biopharmaceutics & pharmacokinetics |c Leon Shargel ; Susanna Wu-Pong ; Andrew B. C. Yu |
| 246 | 1 | 3 | |a Applied biopharmaceutics and pharmacokinetics |
| 250 | |a 6. ed. | ||
| 264 | 1 | |a New York [u.a.] |b McGraw-Hill |c 2012 | |
| 300 | |a XVIII, 811 S. |b Ill., zahlr. graph. Darst. | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 650 | 0 | 7 | |a Biopharmazie |0 (DE-588)4006890-0 |2 gnd |9 rswk-swf |
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| 700 | 1 | |a Wu-Pong, Susanna |e Verfasser |4 aut | |
| 700 | 1 | |a Yu, Andrew B. |d 1945- |e Verfasser |0 (DE-588)172470196 |4 aut | |
| 856 | 4 | 2 | |m Digitalisierung UB Regensburg |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=024787761&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-024787761 | ||
Datensatz im Suchindex
| _version_ | 1804148893296885761 |
|---|---|
| adam_text | Contents
Preface
xiii
Glossary
xv
1.
Introduction to Biopharmaceutics and
Pharmacokinetics
1
Drug Product Performance
1
Biopharmaceutics
1
Pharmacokinetics
3
Clinical Pharmacokinetics
4
Practical Focus
4
Pharmacodynamics
5
Drug Exposure and Drug Response
5
Toxicokinetics and Clinical Toxicology
5
Measurement of Drug Concentrations
6
Basic Pharmacokinetics and
Pharmacokinetic Models
10
Chapter Summary
15
Learning Questions
17
References
17
Bibliography
18
2.
Mathematical Fundamentals in
Pharmacokinetics
19
Math Self-Exam
19
Estimation and the Use of Calculators and
Computers
20
Practice Problems
22
Calculus
24
Graphs
26
Units in Pharmacokinetics
31
Measurement and Use of Significant Figures
32
Units for Expressing Blood Concentrations
33
Statistics
33
Practical Focus
34
Rates and Orders of Reactions
35
Chapter Summary
40
Learning Questions
40
References
42
Bibliography
42
3.
One-Compartment Open Model:
Intravenous Bolus Administration
43
Elimination Rate Constant
44
Apparent Volume of Distribution
45
Clearance
48
Practical Focus
50
Clinical Application
53
Calculation of it from Urinary Excretion Data
53
Practice Problem
54
Clinical Application
56
Chapter Summary
57
Learning Questions
57
Reference
59
Bibliography
59
4.
Multicompartment Models:
Intravenous Bolus Administration
61
Two-Compartment Open Model
63
Clinical Application
68
Practice Problem
68
Practical Focus
69
Three-Compartment Open Model
77
Determination of Compartment Models
79
Practical Application
84
Chapter Summary
86
Learning Questions
87
References
88
Bibliography
89
5.
Intravenous Infusion
91
One-Compartment Model Drugs
91
Infusion Method for Calculating Patient
Elimination Half-Life
95
VII
viii
CONTENTS
Loading Dose Plus IV Infusion
—
One-
Compartment Model
96
Practice Problems
98
Estimation of Drag Clearance and VD from
Infusion Data
100
Intravenous Infusion of Two-Compartment
Model Drugs
100
Practical Focus
102
Chapter Summary
104
Learning Questions
104
Reference
106
Bibliography
106
6.
Drug Elimination and Clearance
107
Drag Elimination
107
The Kidney
108
Renal Drag Excretion
111
Clinical Application
114
Practice Problems
114
Drag Clearance
114
Clearance Models
116
Renal Clearance
118
Determination of Renal Clearance
121
Relationship of Clearance to Elimination
Half-Life and Volume of Distribution
125
Chapter Summary
127
Learning Questions
127
References
129
Bibliography
129
7.
Pharmacokinetics of Oral
Absorption
131
Pharmacokinetics of Drag Absorption
131
Significance of Absorption Rate Constants
133
Zero-Order Absorption Model
133
Clinical Application
— Transdermal
Drug Delivery
134
First-Order Absorption Model
134
Practice Problem
142
Chapter Summary
149
Learning Questions
149
References
150
Bibliography
151
8.
Multiple-Dosage Regimens
153
Drag Accumulation
153
Clinical Example
157
Repetitive Intravenous Injections
158
Intermittent Intravenous Infusion
163
Estimation of
к
and VD of Aminoglycosides
in Clinical Situations
165
Multiple-Oral-Dose Regimen
166
Loading Dose
168
Dosage Regimen Schedules
169
Practice Problems
171
Chapter Summary
173
Learning Questions
174
References
175
Bibliography
175
9.
Nonlinear Pharmacokinetics
177
Saturable
Enzymatic Elimination Processes
179
Practice Problem
180
Drag Elimination by Capacity-Limited
Pharmacokinetics: One-Compartment
Model, IV Bolus Injection
181
Clinical Focus
191
Drags Distributed as One-Compartment
Model and Eliminated by Nonlinear
Pharmacokinetics
191
Chronopharmacokinetics and Time-Dependent
Pharmacokinetics
193
Bioavailability of Drags that Follow Nonlinear
Pharmacokinetics
196
Nonlinear Pharmacokinetics Due to
Drag-Protein Binding
196
Potential Reasons for Unsuspected
Nonlinearity
200
Chapter Summary
200
Learning Questions
200
References
202
Bibliography
203
10.
Physiologic Drug Distribution and
Protein Binding
205
Physiologic Factors of Distribution
205
Clinical Focus
213
Apparent Volume Distribution
213
Practice Problem
216
Protein Binding of Drugs
219
Clinical Examples
221
Effect of Protein Binding on the Apparent
Volume of Distribution
222
Relationship of Plasma Drag-Protein Binding
to Distribution and Elimination
227
Determinants of Protein Binding
231
Kinetics of Protein Binding
232
Practical Focus
233
Determination of Binding Constants and
Binding Sites by Graphic Methods
233
Clinical Significance of Drag-Protein
Binding
236
Modeling Drag Distribution
247
Chapter Summary
248
Learning Questions
249
References
250
Bibliography
251
CONTENTS
IX
11.
Drug
Elimination
and Hepatic
Clearance
253
Route of Drag Administration and Extrahepatic
Drug Metabolism
253
Practical Focus
255
Hepatic Clearance
255
Enzyme Kinetics
257
Clinical Example
261
Practice Problem
263
Anatomy and Physiology of the Liver
265
Hepatic Enzymes Involved in the
Biotransformation
of Drugs
267
Drug Biotransformation Reactions
269
Pathways of Drug Biotransformation
270
First-Pass Effects
282
Hepatic Clearance of a Protein-Bound Drug:
Restrictive and Nonrestrictive Clearance
from Binding
287
Effect of Changing Intrinsic Clearance and/or
Blood Flow on Hepatic Extraction and
Elimination Half-Life after IV and Oral
Dosing
288
Biliary Excretion of Drugs
289
Role of Transporters in Hepatic Clearance
and Bioavailability
292
Chapter Summary
293
Learning Questions
294
References
296
Bibliography
298
12.
Pharmacogenetics
301
Polymorphism
303
Pharmacogenomics
306
Adverse Drug Reactions Attributed
to Genetic Differences
308
Genetic Polymorphism in Drug Metabolism:
Су
tochrome P-450 Isozymes
310
Genetic Polymorphism in Drug Transport:
MDR1 (P-Glycoprotein) and Multidrug
Resistance
311
Genetic Polymorphism in Drug Targets
312
Relationship of Pharmacokinetics/
Pharmacodynamics and Pharmacogenetics/
Pharmacogenomics
313
Clinical Example
315
Summary
316
Glossary
316
Abbreviations
317
References
317
Bibliography
318
13.
Physiologic Factors Related to Drug
Absorption
321
Drug Absorption and Design of a Drag
Product
321
Route of Drag Administration
321
Nature of Cell Membranes
324
Passage of Drugs Across Cell Membranes
326
Oral Drag Absorption During Drag Product
Development
333
Drag Interactions in the Gastrointestinal
Tract
334
Oral Drug Absorption
336
Methods for Studying Factors that Affect
Drug Absorption
348
Clinical Examples
351
Effect of Disease States on Drag Absorption
351
Miscellaneous Routes of Drag
Administration
353
Chapter Summary
355
Learning Questions
356
References
357
Bibliography
359
14.
Biopharmaceutic Considerations in
Drug Product Design and In Vitro
Drug Product Performance
361
Biopharmaceutic Factors Affecting Drag
Bioavailability
361
Rate-Limiting Steps in Drag Absorption
363
Physicochemical Nature of the Drag
366
Formulation Factors Affecting Drag
Product Performance
368
Drug Product Performance, In Vitro: Dissolution
and Drag Release Testing
370
Compendiai
Methods of Dissolution
374
Alternative Methods of Dissolution Testing
376
Meeting Dissolution Requirements
378
Problems of Variable Control in Dissolution
Testing
379
Performance of Drag Products: In Vitro-In Vivo
Correlation
380
Dissolution Profile Comparisons
386
Drug Product Stability
386
Considerations in the Design of a Drag
Product
387
Drag Product Considerations
389
Clinical Example
394
Chapter Summary
398
Learning Questions
399
References
399
Bibliography
401
CONTENTS
15.
Drug Product Performance,
In Vivo: unavailability and
Bioequivalence
403
Drug Product Performance
403
Purpose of unavailability Studies
405
Relative and Absolute Availability
406
Practice Problem
407
Methods for Assessing Bioavailability
407
Bioequivalence Studies
413
Design and Evaluation of Bioequivalence
Studies
414
Study Designs
417
Crossover Study Designs
418
Clinical Example
422
Evaluation of the Data
423
Bioequivalence Example
424
Study Submission and Drug Review
Process
427
The Biopharmaceutics Classification System
431
Generic Biologies
(Biosimilar
Drug
Products)
433
Clinical Significance of Bioequivalence
Studies
435
Special Concerns in Bioavailability and
Bioequivalence Studies
436
Generic Substitution
437
Glossary
440
Chapter Summary
443
Learning Questions
443
References
448
Bibliography
449
16.
Impact of Drug Product Quality
and Biopharmaceutics on Clinical
Efficacy
451
Risks From Medicines
451
Drug Product Quality and Drug Product
Performance
452
Pharmaceutical Development
453
Excipient
Affect on Drug Product
Performance
455
Practical Focus
456
Quality Control and Quality Assurance
457
Risk Management
459
Scale-Up and Postapproval Changes (SUPAC)
461
Product Quality Problems
464
Postmarketing
Surveillance
465
Glossary
465
Chapter Summary
466
Learning Questions
466
References
466
17.
Modified-Release Drug Products
469
Conventional (Immediate-Release) and
Modified-Release Drug Products
469
Biopharmaceutic Factors
473
Dosage form Selection
475
Advantages and Disadvantages of
Extended-Release Products
475
Kinetics of Extended-Release Dosage Forms
476
Pharmacokinetic Simulation of Extended-Release
Products
478
Clinical Examples
480
Types of Extended-Release Products
480
Considerations in the Evaluation of
Modified-Release Products
495
Evaluation of Modified-Release Products
497
Evaluation of In Vivo Bioavailability Data
499
Chapter Summary
501
Learning Questions
501
References
502
Bibliography
503
18.
Targeted Drug Delivery Systems and
Biotechnological Products
505
Biotechnology
506
Drug Carriers and Targeting
514
Targeted Drag Delivery
519
Pharmacokinetics of Biopharmaceuticals
521
Bioequivalence and Comparability of
Biotechnology-Derived Drug Products
522
Chapter Summary
523
Learning Questions
524
References
524
Bibliography
525
19.
Relationship Between
Pharmacokinetics and
Pharmacodynamics
527
Pharmacodynamics and Pharmacokinetics
527
Relationship of Dose to
Pharmacologie
Effect
534
Relationship Between Dose and Duration of
Activity (ieff), Single IV Bolus Injection
536
Practice Problem
536
Effect of Both Dose and Elimination Half-Life
on the Duration of Activity
537
Effect of Elimination Half-Life on Duration
of Activity
537
Clinical Examples
539
Rate of Drug Absorption and Pharmacodynamic
Response
541
Drug Tolerance and Physical Dependency
542
Hypersensitivity and Adverse Response
543
CONTENTS
XI
Drag
Distribution and Pharmacologie
Response
544
Pharmacodynamic Models
545
Drug Exposure-Pharmacologic Response
Relationships
558
Chapter Summary
559
Learning Questions
560
References
561
Bibliography
563
20.
Application of Pharmacokinetics to
Clinical Situations
565
Medication Therapy Management
565
Individualization of Drug Dosage Regimens
566
Therapeutic Drug Monitoring
567
Clinical Example
574
Design of Dosage Regimens
576
Conversion from Intravenous Infusion
to Oral Dosing
578
Determination of Dose
579
Practice Problems
580
Effect of Changing Dose and Dosing
Interval on C·^, C^, and C;
580
Determination of Frequency of Drag
Administration
581
Determination of Both Dose and Dosage
Interval
582
Determination of Route of Administration
583
Dosing of Drags in Infants and Children
584
Dosing of Drugs in the Elderly
585
Dosing of Drugs in the Obese Patient
588
Pharmacokinetics of Drag Interactions
590
Inhibition of Drag Metabolism
594
Inhibition of Monoamine
Oxidase
(MAO)
595
Induction of Drag Metabolism
596
Inhibition of Drag Absorption
596
Inhibition of Biliary Excretion
596
Altered Renal
Reabsorption Due
to
Changing Urinary
pH 596
Practical Focus
597
Effect of Food on Drag Disposition
597
Adverse Viral Drug Interactions
597
Population Pharmacokinetics
597
Regional Pharmacokinetics
608
Chapter Summary
609
Learning Questions
610
References
613
Bibliography
614
21.
Dose Adjustment in Renal and Hepatic
Disease
617
General Approaches for Dose Adjustment
in Renal Disease
618
Measurement of Glomeralar Filtration Rate
621
Seram Creatinine Concentration and Creatinine
Clearance
622
Practice Problems
624
Dose Adjustment for
Uremie
Patients
627
Extracorporeal Removal of Drags
638
Clinical Examples
642
Effect of Hepatic Disease on
Pharmacokinetics
645
Chapter Summary
651
Learning Questions
652
References
653
Bibliography
655
22.
Physiologic Pharmacokinetic Models,
Mean Residence Time, and Statistical
Moment Theory
657
Physiologic Pharmacokinetic Models
658
Mean Residence Time
670
Statistical Moment Theory
674
Selection of Pharmacokinetic Models
687
Chapter Summary
689
Learning Questions
689
References
690
Bibliography
691
Appendix A Statistics
693
Appendix
В
Applications of Computers in
Pharmacokinetics
707
Appendix
С
Solutions to Frequently
Asked Questions (FAQs) and
Learning Questions
717
Appendix
D
Guiding Principles for
Human and Animal
Research
761
Appendix
E
Popular Drugs and
Pharmacokinetic
Parameters
767
Index
773
Renal Impairment
617
Pharmacokinetic Considerations
617
|
| any_adam_object | 1 |
| author | Shargel, Leon 1941- Wu-Pong, Susanna Yu, Andrew B. 1945- |
| author_GND | (DE-588)1145926010 (DE-588)172470196 |
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| id | DE-604.BV039929467 |
| illustrated | Illustrated |
| indexdate | 2024-07-10T00:14:22Z |
| institution | BVB |
| isbn | 9780071603935 007160393X |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-024787761 |
| oclc_num | 800308153 |
| open_access_boolean | |
| owner | DE-355 DE-BY-UBR DE-19 DE-BY-UBM |
| owner_facet | DE-355 DE-BY-UBR DE-19 DE-BY-UBM |
| physical | XVIII, 811 S. Ill., zahlr. graph. Darst. |
| publishDate | 2012 |
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| publisher | McGraw-Hill |
| record_format | marc |
| spelling | Shargel, Leon 1941- Verfasser (DE-588)1145926010 aut Applied biopharmaceutics & pharmacokinetics Leon Shargel ; Susanna Wu-Pong ; Andrew B. C. Yu Applied biopharmaceutics and pharmacokinetics 6. ed. New York [u.a.] McGraw-Hill 2012 XVIII, 811 S. Ill., zahlr. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Biopharmazie (DE-588)4006890-0 gnd rswk-swf Pharmakokinetik (DE-588)4115557-9 gnd rswk-swf Biopharmazie (DE-588)4006890-0 s DE-604 Pharmakokinetik (DE-588)4115557-9 s Wu-Pong, Susanna Verfasser aut Yu, Andrew B. 1945- Verfasser (DE-588)172470196 aut Digitalisierung UB Regensburg application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=024787761&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Shargel, Leon 1941- Wu-Pong, Susanna Yu, Andrew B. 1945- Applied biopharmaceutics & pharmacokinetics Biopharmazie (DE-588)4006890-0 gnd Pharmakokinetik (DE-588)4115557-9 gnd |
| subject_GND | (DE-588)4006890-0 (DE-588)4115557-9 |
| title | Applied biopharmaceutics & pharmacokinetics |
| title_alt | Applied biopharmaceutics and pharmacokinetics |
| title_auth | Applied biopharmaceutics & pharmacokinetics |
| title_exact_search | Applied biopharmaceutics & pharmacokinetics |
| title_full | Applied biopharmaceutics & pharmacokinetics Leon Shargel ; Susanna Wu-Pong ; Andrew B. C. Yu |
| title_fullStr | Applied biopharmaceutics & pharmacokinetics Leon Shargel ; Susanna Wu-Pong ; Andrew B. C. Yu |
| title_full_unstemmed | Applied biopharmaceutics & pharmacokinetics Leon Shargel ; Susanna Wu-Pong ; Andrew B. C. Yu |
| title_short | Applied biopharmaceutics & pharmacokinetics |
| title_sort | applied biopharmaceutics pharmacokinetics |
| topic | Biopharmazie (DE-588)4006890-0 gnd Pharmakokinetik (DE-588)4115557-9 gnd |
| topic_facet | Biopharmazie Pharmakokinetik |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=024787761&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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