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Clinical Pharmacology for Medical Students -Terziivanov, Atanasova, 2017

Clinical Pharmacology for Medical Students -Terziivanov, Atanasova, 2017

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Contents
Preface 11
 
Chapter 1. Subject matter, aims and goals of clinical pharmacology as a medical scientific discipline. Clinical Pharmacology - the scientific basis
 
of drug therapy — Dimiter Terziivanov 13
 
1.1. Introduction to clinical pharmacology
 
Subject matter and goals •. 13
 
1.2 Clinical Pharmacology Service and Expertise 15
 
1.3. Teaching and training in Clinical Pharmacology .• 17
 
1.4. Clinical pharmacology research 23
 
1.5. Clinical Pharmacology - the scientific basis of drug therapy 24
of-clinical trials - Ivanka Atanasova 35
 
3.1. Discovery and development of medicines - methods for scientific discovery of new drug molecules, preclinical
 
and toxicological tests 35
 
3.2. Preclinical and toxicological testing 40
 
3.3. Types of clinical trials, design, inclusion and exclusion criteria,
 
endpoints for assessment and statistical analysis 42
 
3.4. The concept of Good Clinical Practice, ethical committees, infonned consent, quality assurance and monitoring
 
of clinical trials   51
 
Chapter 4. Applied aspects of the scientific discover}'1 and development
 
of new generic drugs - Ivanka Atanasova 54
 
4.1. Generic drugs 54
 
4.2. Biosimilar drugs   58
 
4.3. Patient compliance - pharmionics, a new discipline 61
 
4.4. The concept of complementary and alternative medicine 63
Chapter 5. Clinical Pharmacokinetics - Dimiter Terziivanov 65
 
5.1. Physiological aspects of clinical pharmacokinetics. Absorption and bioavailability of medicine products. Numerical evaluation
 
of the area under the curve of plasma (blood) drug concentrations 66
 
5.2. Presystemic elimination, first-pass effect (metabolism) 72
 
5.3. Physiological aspects of clinical pharmacokinetics. Drug distribution 73
 
5.4. Physiological aspects of clinical pharmacokinetics. Drug metabolism .... 75
 
5.5. Physiological aspects of clinical pharmacokinetics. Drug excretion 77
 
5.6. Mathematical aspects of clinical pharmacokinetics. Single dosing
 
of drugs 78
 
5.7. Pharmacokinetics of multiple drug dosing 97
 
5.8. Clinical cases - Ю8
 
Chapter 6. Clinical Pharmacodynamics. Dose-effect and concentrations-time-effect
 
relationships -Dimiter Terziivanov   110
 
6.1. Types of pharmacological effects according to their rate
 
and duration of occurrence 110
 
6.2. Differentiating between pharmacological
 
and therapeutic drug effects П2
 
6.3. Biomarkers, clinical endpoints and surrogate endpoints 114
 
6.4. Therapeutic or toxic effects due to more than
 
one pharmacological effect 116
 
6.5. Subordination and hierarchy in the therapeutic process 117
 
6.6. Types of pharmacodynamic activity of drugs 118
 
6.7. Pharmacotherapeutic aspects of prolonged drug therapy 119
 
6.8. Dose/effect and concentration/effect relationships... 122
 
6.9. Kinetics of drug/receptor interaction. Pharmacological models 127
 
6.10. Pharmacodynamic models 129
 
Chapter 7. Clinical Pharmacogenetics. The concept of personalized therapy -
 
Dimiter Terziivanov , 137
 
7.1. Evolutionary considerations and contemporary development
 
of the issue relating to genetic polymorphism in drug metabolism 137
 
7.2. Genetic aspects of the pharmacokinetic behavior of drugs 147
 
7.3. Methods of pharmacokinetic phenotyping 152
 
7.4. Quantitative and qualitative variations in drug response 157
 
7.5. The concept of personalized therapy 159
 
7.6. Carcinogenesis and genetic polymorphism of drug metabolism 1.62
 
7.7. Genetic aspects of pharmacotherapy.
 
Genetic preconditions for adverse drug reactions 163
 
7.8. Clinical prospects for phannacogenetics 164
 
7.9. Regulatory science and pharmacogenomics 165
 
Chapter 8. Clinical pharmacological characteristics of pediatric drug therapy -
 
Ivanka Atanasova.... 167
 
8.1. Growth and development of the organism and effect
 
on the drug disposition 168
8.2. Drug distribution and plasma protein binding in childhood... 170
 
8.3. Drug metabolism in childhood 172
 
8.4. Drug elimination in childhood 173
 
8.5. Pharmacogenetics and its impact on pharmacokinetics
 
and pharmacodynamics 175
 
8.6. Specific features of drug therapy in children.
 
Mode of administration and dosage forms in childhood 175
 
8.7. Dosing in children 176
 
8.8. Defining the dosing interval in children 177
 
8.9. Drug legislation: better medicines for children.
 
EU Pediatric Regulation 177
 
8.10. Clinical cases 178
 
Chapter 9. Clinical pharmacological aspects of drug therapy in elderly people -
 
Ivanka Atanasova 181
 
9.1. Drag pharmacokinetics in elderly people, drug absorption 182
 
9.2. Drug distribution 182
 
9.3. Drug metabolism in elderly people 183
 
9.4. Drug elimination 184
 
9.5. Pharmacodynami c changes 185
 
9.6. Clinical case 188
 
Chapter 10. Clinical pharmacological particularities of the drug therapy in pregnant
 
and lactating women - Ivanka Atanasova 189
 
10.1. Pharmacokinetic changes in pregnant women 189
 
10.2. Drug distribution 190
 
10.3. Metabolism 192
 
10.4. Clinical situations requiring drug administrtion during pregnanc\ 193
 
10.5. Drag groups according to the risk during pregnancy
 
(US FDA categories) 196
 
10.6. Drugs taken during lactation 197
 
Chapter 11. Drug interactions. Principles, types and clinical significance
 
Ivanka Atanasova 199
 
11.1. Pharmacokinetic drug interactions    200
 
11.2. Pharmacodynamic drag interactions 211
 
11.3. Clinical case    214
 
Chapter 12. Clinical pharmacological considerations of drug therapy in patients with renal failure and/or hepatic impairments -Dimiter Terziivanov 215
 
12.1. Individualization of the drug therapy in patients
 
with renal failure 215
 
12.2. Determining safe individualized dosage regimens for renal failure patients with a. various degree
 
of reduced renal function 223
12.3. Extracorporeal elimination of drugs 233
 
12.4. Drug therapy individualization in patients with hepatic failure 234
 
Chapter 13. Adverse drug reactions and safe drug therapy. The concept of pharmcovigilance. Pharmacoepidemiological trials -Dimiter Terziivanov 244
 
13.1. Adverse effects to medications with long-term use that have been established in therapeutic practice (the so called
 
WELL ESTABLISHED USE) 246
 
13.2. Adverse drug effects to new medicines on the market 247
 
13.3. Types of adverse drug reactions according to WHO 248
 
13.4. Drug-induced syndromes and diseases   257
 
13.5. Introduction to pharmacoepidemiology (PhE).
 
Pharmacoepidemiological monitoring methods for detecting drug-induced adverse reactions. Pharmacoepidemiological approaches for pharmacotherapy optimization 260
 
13.6. The concept of pharrnacovigilance 267
 
Chapter 14. Clinical pharmacological aspects of individualized drug therapy with some pharmacotherapeutic drug classes. Evidence based therapy -Ivanka Atanasova 271
 
14.1. Evidence-based medicine 273
 
14.2. Antihypertensive drugs - evidence-based therapy, meta-analyzes
 
and randomized clinical trials with these drugs 275
 
14.3. II ID - evidence-based therapy, randomized clinical tests
 
and individualization of therapy based on these data 279
 
14.4. Heart Failure (1 IF) 281
 
14.5. Edema syndrome 294
 
14.6. Antidiabetic non-insulin drugs •.. 297
 
14.7. Pain syndrome 306
 
14.8. Bronchial asthma and COPD '.. 316
 
14.°. I Jpper and lower dyspeptic syndrome : 323
 
14.10. Immunosuppression in transplant patients   333
 
14.11. Antilipemic therapy 336
 
Chapter 15. Advanced molecular therapies of the 21 st century -
 
Ivanka Atanasova    345
 
15.1. Diseases for which modern therapies can be applied
 
successfully , 346
 
15.2. Recombinant products   350
 
Chapter 16. Pharmaeoeeonomics - key concepts and aims
 
of pharmacoeconomical studies - Dimiter Terziivanov 370
 
16.1. The concept of pharmaeoeeonomics 370
 
16.2. Significance for prophylactic and clinical medicine 375
pharmacodynamic modelling and Bayesian adaptive control
 
of drug dosage regimens - Dimiter Terziivanov 378
 
17.1. The concept of therapeutic variability 378
 
17.2. Understanding for population pharmacokinetics
 
and pharmacodynamics and Bayesian adaptive control
 
of drug dosage regimens 382
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