Introduction to pharmaceutical medicine:
Saved in:
| Main Author: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Frankfurt, M.
<<R. G.>> Fischer
2008
|
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Item Description: | Literaturangaben |
| Physical Description: | 221 S. 21 cm |
| ISBN: | 9783830111856 |
Staff View
MARC
| LEADER | 00000nam a2200000 c 4500 | ||
|---|---|---|---|
| 001 | BV035452214 | ||
| 003 | DE-604 | ||
| 005 | 20090519 | ||
| 007 | t | ||
| 008 | 090424s2008 gw |||| 00||| eng d | ||
| 015 | |a 08,N37,0721 |2 dnb | ||
| 015 | |a 08,A51,1124 |2 dnb | ||
| 016 | 7 | |a 990119793 |2 DE-101 | |
| 020 | |a 9783830111856 |c kart. : EUR 32.00 (DE), sfr 54.90 (freier Pr.) |9 978-3-8301-1185-6 | ||
| 024 | 3 | |a 9783830111856 | |
| 035 | |a (OCoLC)281175483 | ||
| 035 | |a (DE-599)DNB990119793 | ||
| 040 | |a DE-604 |b ger |e rakddb | ||
| 041 | 0 | |a eng | |
| 044 | |a gw |c XA-DE-HE | ||
| 049 | |a DE-355 | ||
| 082 | 0 | |a 615.1 |2 22/ger | |
| 084 | |a XI 1703 |0 (DE-625)152977:12909 |2 rvk | ||
| 084 | |a 610 |2 sdnb | ||
| 100 | 1 | |a Bucurescu, Septimiu Tudor |e Verfasser |4 aut | |
| 245 | 1 | 0 | |a Introduction to pharmaceutical medicine |c Septimiu Tudor Bucurescu |
| 264 | 1 | |a Frankfurt, M. |b <<R. G.>> Fischer |c 2008 | |
| 300 | |a 221 S. |c 21 cm | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 500 | |a Literaturangaben | ||
| 650 | 4 | |a Pharmakologie | |
| 650 | 0 | 7 | |a Pharmakologie |0 (DE-588)4045687-0 |2 gnd |9 rswk-swf |
| 689 | 0 | 0 | |a Pharmakologie |0 (DE-588)4045687-0 |D s |
| 689 | 0 | |5 DE-604 | |
| 856 | 4 | 2 | |m HBZ Datenaustausch |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017372227&sequence=000004&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-017372227 | ||
Record in the Search Index
| _version_ | 1804138903637065728 |
|---|---|
| adam_text | Contents
Abbreviations... 14
History of drugs discovery... 15
Part I: Drugs as scientific products
1. Introduction
1.1. Scientific definition of drugs ... 20
1.2. Scientific classification of drugs ... 20
2. Pharmaceutical scientific environment
2.1. Pharmaceutical importance of health monitors
2.1.1. Public health agencies accomplishments with pharmaceutical
implication ... 22
2.1.2. Epidemiology agencies accomplishments with
pharmaceutical implication ... 24
2.2. Pharmaceutical importance of healthcare service providers
2.2.1. Healthcare Service providers structuring ... 26
2.2.2. Healthcare service providers profit orientation ... 27
3. Pharmaceutical quality
3.1. Quality in medical research
3.1.1. History of Good Research Practice ... 30
3.1.2. Researchpersonnel... 31
3.1.3. Research institutions ... 31
3.1.4. Research materials ... 32
3.1.5. Research documents ... 32
3.2. Quality in pharmaceutical preclinical development
3.2.1. History of Good Laboratory Practice ... 32
3.2.2. Preclinical study personnel... 34
3.2.3. Preclinical study institutions ... 35
3.2.4. Preclinical study materials ... 35
3.2.5. Preclinical study documents ... 36
3.3. Quality in pharmaceutical clinical development
3.3.1. History of Good Clinical Practice ... 38
3.3.2. Clinical study personnel... 39
3.3.3. Clinical study institutions ... 41
3.3.4. Clinical study documents ... 41
3.4. Pharmaceutical non—quality drugs
3.4.1. History of pharmaceutical non—quality drugs ... 42
8
3.4.2. Consequences of using pharmaceutical non-quality drugs ...
43
3.4.3. Prevention of using pharmaceutical non~quality drugs ... 44
4. Pharmaceutical research
4.1. Drug discovery
4.1.1. Target identification ... 48
4.1.2. Target validation ... 48
4.1.3. Leadidentification ... 49
4.1.4. Lead optimization ... 51
4.2. Encouraging therapeutic innovation by patenting
4.2.1. Patenting methodology ... 53
4.2.2. International patenting harmonization ... 54
4.3. Innovative crisis
4.3.1. Causes of innovative crisis ... 55
4.3.2. Consequences of innovative crisis ... 56
4.3.3. Overcoming the innovative crisis ... 57
5. Pharmaceutical development
5.1. Dosage form development
5.1.1. Roles of the dosage form ... 60
5.1.2. Phases of developing the dosage form ... 62
5.1.3. Preclinical chemical-pharmaceutical dossier ... 62
5.2. Preclinical development
5.2.1. Phase of preclinical study ... 66
5.2.2. Preclinical pharmaco-toxicological dossier ... 68
5.3. Clinical development
5.3.1. Phases of clinical studies ... 69
5.3.2. Clinical dossier ... 72
6. Pharmaceutical regulation
6.1. Drug regulation
6.1.1. Drug Submission ... 74
6.1.2. Drug marketing authorization ... 76
6.1.3. Internationalregulations harmonization ... 76
7. Pharmaceutical surveillance
7.1. Pharmacovigilance
7.1.1. History of pharmacovigilance ... 80
7.1.2. Pharmacovigilance studies ... 81
7.1.3. Pharmacovigilance consequences ... 83
7.2. Pharmacoeconomy
9
7.2.1. History of pharmacoeconomy ... 85
7.2.2. Pharmacoeconomy studies ... 85
7.2.3. Pharmacoeconomy consequences ... 87
8. Medication use
8.1. Medication prescribing
8.1.1.Diagnosis...90
8.1.2. Choosing the personalized drug ... 91
8.1.3. Patient education ... 95
8.1.4. Monitoring the treatment... 95
8.2. Medication dispensing
8.2.1. Drug dispensing ... 96
8.3. Compliance
8.3.1. Factors that influence compliance ... 97
8.3.2. Decreased compliance ... 97
8.3.3. Increased compliance ... 98
8.4. Medication error
8.4.1. Prescribing error ... 99
8.4.2. Dispensing error ... 101
8.4.3. Administering error ... 102
9. Biopharmaceuticals
9.1. History of biopharmaceuticals ... 106
9.2. Research of biopharmaceuticals
9.2.1. Recombinant DNA technology ... 109
9.2.2. Monoclonal antibody development... 110
9.2.3. Biochips... 111
9.2.4. Bioelectronics ... 112
9.3. Development of biopharmaceuticals
9.3.1. Biopharmaceuticals development... 114
9.3.2. Biosimilars development... 114
9.4. Biopharmaceuticals as a solution to innovative crisis
9.4.1. Molecular diagnosis and therapy of infectious diseases ...
116
9.4.2. Molecular diagnosis and therapy of simple genetic diseases
... 117
9.4.3. Molecular diagnosis and therapy of complex genetic diseases
... 119
9.4.4. Molecular diagnosis and therapy of cancers ... 120
9.5. Biopharmaceuticals use
10
9.5.1. Biopharmaceuticals use stimulations ... 122
9.5.2. Biopharmaceuticals use restrictions ... 123
9.6. Response of innovative pharmaceutical companies to
biopharmaceutical competition
9.6.1. Biopharmaceutical diversification ... 123
9.6.2. Biopharmaceutical cooperation ... 124
10. Improving the pharmaceutical scientific activity
10.1. Contributions of the World Health Organization
10.1.1. Establishing pharmaceutical scientific regulations ... 126
10.1.2. Promoting pharmaceutical quality ... 127
10.1.3. Collecting and analyzing health data ... 127
10.2. Contributions of national governments
10.2.1. Enforcing pharmaceutical scientific regulations ... 127
10.2.2. Promoting pharmaceutical quality ... 128
10.2.3. Improving the activity of health agencies ... 128
10.3. Contributions of the pharmaceutical industry
10.3.1. Supporting the development of healthcare Service providers
... 129
10.3.2. Guaranteeing pharmaceutical quality ... 130
10.3.3. Improving pharmaceutical surveillance ... 130
10.4. Contributions of academia
10.4.1. Training pharmaceutical medicine specialists ... 131
10.4.2. Improving pharmaceutical research and development ...
131
Part II: Drugs as commercial products
11. Introduction
11.1. Commercial definitionof drugs ... 133
11.2. Commercial classification of drugs ... 133
12. Pharmaceutical commercial environment
12.1. Pharmaceutical importance of healthcare insurers
12.1.1. Types of healthcare insurers ... 135
12.1.2. Healthcare insurers accomplishments with pharmaceutical
implication ... 137
12.2. Pharmaceutical importance of healthcare mediators
12.2.1. Healthcare System conflicts ... 138
12.2.2. Healthcare mediators accomplishments with pharmaceutical
implication... 139
13. Pharmaceutical portfolio
11
13.1. Innovative drugs portfolio
13.1.1. Innovative drugs market segmentation ... 144
13.1.2. Introducing a drug into the innovative drugs portfolio ...
145
13.1.3. Removing a drug from the innovative drugs portfolio ...
145
13.2. Generics portfolio
13.2.1. Generics market segmentation ... 146
13.2.2. Introducing a drug into the generics portfolio ... 147
13.2.3. Removing a drug from the generics portfolio ... 148
14. Pharmaceutical pricing
14.1. Innovative drugs pricing
14.1.1. Establishing the price for innovative drugs ... 150
14.1.2. Increasing the price for innovative drugs ... 151
14.1.3. Decreasing the price for innovative drugs ... 152
14.2. Generics pricing
14.2.1. Establishing the price for generics ... 154
14.2.2. Increasing the price for generics ... 155
14.2.3. Keeping the price for generics low ... 156
15. Pharmaceutical distribution
15.1. Medication distribution
15.1.1. Functions of the pharmaceutical wholesaler ... 158
15.1.2. Types of pharmaceutical distribution Channels ... 159
15.1.3. Distribution Channel control by the pharmaceutical
wholesaler ... 160
16. Pharmaceutical promotion
16.1. Innovative drugs promotion
16.1.1. Innovative drugs publicity... 163
16.1.2. Innovative drugs promotion ... 164
16.2. Generics promotion
16.2.1. Generics publicity... 166
16.2.2. Generics promotion ... 167
17. Pharmaceutical sales
17.1. Innovative drugs sales
17.1.1. Study of innovative drugs sales ... 169
17.1.2. Improving innovative drugs sales ... 170
17.2. Generics sales
17.2.1. Study of generics sales ... 173
12
17.2.2. Improving generics sales ... 173
18. Pharmaceutical consumption
18.1. Innovative drugs consumption
18.1.1. Study of innovative drugs consumption ... 176
18.1.2. Abnormal innovative drugs consumption ... 177
18.2. Generics consumption
18.2.1. Study of generics consumption ... 178
18.2.2. Abnormal generics consumption ... 179
19. Generics
19.1. Historyof generics ... 181
19.2. Legal Status of generics ... 183
19.3. Pharmaceutical development of generics
19.3.1. Evaluation of generics ... 185
19.3.2. Dosage form development... 186
19.3.3. Clinical development of generics ... 186
19.4. Genericsuse
19.4.1. Generics use stimulations ... 187
19.4.2. Generics use restrictions ... 188
19.5. Response of innovative pharmaceutical companies to generic
competition
19.5.1. Generic diversification ... 189
19.5.2. Pharmaceutical integration ... 189
20. Improving the pharmaceutical commercial activity
20.1. Contributions of the World Health Organization
20.1.1. Establishing pharmaceutical commercial regulations ... 192
20.1.2. Preventing abnormal consumption ... 192
20.2. Contributions of national governments
20.2.1. Improving the activity of healthcare insurers ... 193
20.2.2. Controlling pharmaceutical sales ... 193
20.2.3. Preventing abnormal consumption ... 193
20.3. Contributions of the pharmaceutical industry
20.3.1. Improving the activity of healthcare insurers ... 194
20.3.2. Supporting the development of healthcare product providers
... 194
20.3.3. Improving the pharmaceutical portfolio ... 195
20.4. Contributions ofacademia
20.4.1. Supporting the development of healthcare product providers
... 195
13
20.4.2. Preventing abnormal consumption ... 196
Glossary... 198
Index...211
Abbreviations
ADR: adverse drug reaction
AE: adverse event
CRO: Contract Research Organization
CSO: Contract Sales Organization
EMEA: European Medicines Evaluation Agency
EU: European Union
FDA: (United States) Food and Drug Administration
GCP: Good Clinical Practice
GLP: Good Laboratory Practice
GMP: (current) Good Manufacturing Practice
GRP: Good Research Practice
ICH: International Conference on Harmonization
MOH: (National) Ministry of Health
DRA: (National) Drug Regulatory Agency
EA: (National) Epidemiology Agency
PHA: (National) Public Health Agency
OECD: Organization for Economic Co~operation and
Development
OTC: over the counter (drug)
R D: (pharmaceutical) research and development
Rx: prescription only medicine (POM)
SOP: Standard operating procedure
UN: United Nations (Organization)
UNICEF: United Nations Children s Fund
US: United States (of America)
WHO: World Health Organization
14
|
| any_adam_object | 1 |
| author | Bucurescu, Septimiu Tudor |
| author_facet | Bucurescu, Septimiu Tudor |
| author_role | aut |
| author_sort | Bucurescu, Septimiu Tudor |
| author_variant | s t b st stb |
| building | Verbundindex |
| bvnumber | BV035452214 |
| classification_rvk | XI 1703 |
| ctrlnum | (OCoLC)281175483 (DE-599)DNB990119793 |
| dewey-full | 615.1 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.1 |
| dewey-search | 615.1 |
| dewey-sort | 3615.1 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| format | Book |
| fullrecord | <?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01493nam a2200421 c 4500</leader><controlfield tag="001">BV035452214</controlfield><controlfield tag="003">DE-604</controlfield><controlfield tag="005">20090519 </controlfield><controlfield tag="007">t</controlfield><controlfield tag="008">090424s2008 gw |||| 00||| eng d</controlfield><datafield tag="015" ind1=" " ind2=" "><subfield code="a">08,N37,0721</subfield><subfield code="2">dnb</subfield></datafield><datafield tag="015" ind1=" " ind2=" "><subfield code="a">08,A51,1124</subfield><subfield code="2">dnb</subfield></datafield><datafield tag="016" ind1="7" ind2=" "><subfield code="a">990119793</subfield><subfield code="2">DE-101</subfield></datafield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">9783830111856</subfield><subfield code="c">kart. : EUR 32.00 (DE), sfr 54.90 (freier Pr.)</subfield><subfield code="9">978-3-8301-1185-6</subfield></datafield><datafield tag="024" ind1="3" ind2=" "><subfield code="a">9783830111856</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(OCoLC)281175483</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)DNB990119793</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-604</subfield><subfield code="b">ger</subfield><subfield code="e">rakddb</subfield></datafield><datafield tag="041" ind1="0" ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="044" ind1=" " ind2=" "><subfield code="a">gw</subfield><subfield code="c">XA-DE-HE</subfield></datafield><datafield tag="049" ind1=" " ind2=" "><subfield code="a">DE-355</subfield></datafield><datafield tag="082" ind1="0" ind2=" "><subfield code="a">615.1</subfield><subfield code="2">22/ger</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">XI 1703</subfield><subfield code="0">(DE-625)152977:12909</subfield><subfield code="2">rvk</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">610</subfield><subfield code="2">sdnb</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Bucurescu, Septimiu Tudor</subfield><subfield code="e">Verfasser</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Introduction to pharmaceutical medicine</subfield><subfield code="c">Septimiu Tudor Bucurescu</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">Frankfurt, M.</subfield><subfield code="b"><<R. G.>> Fischer</subfield><subfield code="c">2008</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">221 S.</subfield><subfield code="c">21 cm</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="b">n</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="b">nc</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">Literaturangaben</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Pharmakologie</subfield></datafield><datafield tag="650" ind1="0" ind2="7"><subfield code="a">Pharmakologie</subfield><subfield code="0">(DE-588)4045687-0</subfield><subfield code="2">gnd</subfield><subfield code="9">rswk-swf</subfield></datafield><datafield tag="689" ind1="0" ind2="0"><subfield code="a">Pharmakologie</subfield><subfield code="0">(DE-588)4045687-0</subfield><subfield code="D">s</subfield></datafield><datafield tag="689" ind1="0" ind2=" "><subfield code="5">DE-604</subfield></datafield><datafield tag="856" ind1="4" ind2="2"><subfield code="m">HBZ Datenaustausch</subfield><subfield code="q">application/pdf</subfield><subfield code="u">http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017372227&sequence=000004&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA</subfield><subfield code="3">Inhaltsverzeichnis</subfield></datafield><datafield tag="999" ind1=" " ind2=" "><subfield code="a">oai:aleph.bib-bvb.de:BVB01-017372227</subfield></datafield></record></collection> |
| id | DE-604.BV035452214 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-09T21:35:35Z |
| institution | BVB |
| isbn | 9783830111856 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-017372227 |
| oclc_num | 281175483 |
| open_access_boolean | |
| owner | DE-355 DE-BY-UBR |
| owner_facet | DE-355 DE-BY-UBR |
| physical | 221 S. 21 cm |
| publishDate | 2008 |
| publishDateSearch | 2008 |
| publishDateSort | 2008 |
| publisher | <<R. G.>> Fischer |
| record_format | marc |
| spelling | Bucurescu, Septimiu Tudor Verfasser aut Introduction to pharmaceutical medicine Septimiu Tudor Bucurescu Frankfurt, M. <<R. G.>> Fischer 2008 221 S. 21 cm txt rdacontent n rdamedia nc rdacarrier Literaturangaben Pharmakologie Pharmakologie (DE-588)4045687-0 gnd rswk-swf Pharmakologie (DE-588)4045687-0 s DE-604 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017372227&sequence=000004&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Bucurescu, Septimiu Tudor Introduction to pharmaceutical medicine Pharmakologie Pharmakologie (DE-588)4045687-0 gnd |
| subject_GND | (DE-588)4045687-0 |
| title | Introduction to pharmaceutical medicine |
| title_auth | Introduction to pharmaceutical medicine |
| title_exact_search | Introduction to pharmaceutical medicine |
| title_full | Introduction to pharmaceutical medicine Septimiu Tudor Bucurescu |
| title_fullStr | Introduction to pharmaceutical medicine Septimiu Tudor Bucurescu |
| title_full_unstemmed | Introduction to pharmaceutical medicine Septimiu Tudor Bucurescu |
| title_short | Introduction to pharmaceutical medicine |
| title_sort | introduction to pharmaceutical medicine |
| topic | Pharmakologie Pharmakologie (DE-588)4045687-0 gnd |
| topic_facet | Pharmakologie |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017372227&sequence=000004&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT bucurescuseptimiutudor introductiontopharmaceuticalmedicine |