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MINISTRY of HEALTH of UKRAINE

BUKOVYNIAN STATE MEDICAL UNIVERSITY








«ASSERT»


Act. prorector
of educational work

Professor. Yu.T.Akhtemiychuk

«____» ___________ 2009




Reference book for students of STUDY OF DISCIPLINE

«CLINICAL PHARMACOLOGY»


(structure, goals, content of the subject, principles of rating, control questions)


A reference book for a student is made on the basis of operating curriculum and program from clinical pharmacology for the students of higher medical educational establishments of formation of III-iv of levels of accreditation (MHD of Ukraine, Central methodical cabinet of higher medical education, Kyiv, 2008).


It is approved on the methodical conference of department of internal medicine, clinical pharmacology and professional diseases on June, 15, 2009 (protocol № 41) and on meeting of subject methodical commission on therapeutic disciplines on June, 24, in 2009 (protocol № 16)


Chief of the department of internal

medicine, clinical pharmacology and

occupational diseases, professor O.S. Chuchlina


Chief of the subject methodical commission

on therapeutic disciplines, professor V.K.Tashchuk


Chernivtsi, 2009

Educational discipline is «Clinical pharmacology»

1.Entry:

«Clinical pharmacology» as educational discipline:

а) based on the study of medical chemistry, biological and bioorganic chemistry, medical and biological physics, normal and pathological physiology, microbiology, pharmacology, propaedeutics of internal medicine, internal medicine and integrated with the noted disciplines;

б) mortgages bases of study of principles of rational choice of medications for treatment of concrete patient, and also methods of control of therapeutic efficiency and safety of application of medications.

в) forms ability of optimization of charts of medicinal therapy of different diseases for the leadthrough of the maximally individualized rational medical therapy for a concrete patient.

^ Organization of educational process is carried out after credit-module by the system in accordance with the requirements of “Bolognese process”.

Program of discipline «Clinical pharmacology» is laid out on 5 year of studies and makes 1,5 credits of ECTS (45 hours), from which 30 hours are the tutorials (as practical studies – 30 hours) and 15 hours, is extracurricular work of students. A table of contents of the module is «Clinical pharmacology» it is structured on 2 intensional modules.


^ 2. The structured initial plan of discipline «Clinical pharmacology» after specialty «Medical affair»


^ Structure of educational discipline

Amount of hours, from them

Year of studies

Type of control

All sum
(hours/ credits)


Audience

ExW

Lectures

Practical studies (tutorials)

^ Total course in hours/Credits of ECTS

45/1,5

0

30

15

V




Module 1:

clinical pharmacology


Semantic modules – 2:

intensional module 1


intensional module 2

45/1,5 credits of ECTS


0

30


12


14

15


7


8

V

Current and final module control

Including final control of module







4




V

Final module control


Intensional module 1 is denotated the «General questions of clinical pharmacology. Clinical pharmacology of certain groups of medicines I» (Anti-inflammatory drugs. Antibiotics, synthetic antibacterial chemotherapeutic agents, antiviral, antiprotozoan drugs, and antihelminth medicines)

Intensional module 2 is denotated the «Clinical pharmacology of certain groups of medicines ІІ (agents that used in treatment of diseases of organs of blood circulation of blood, breathing and digestive systems)»

  • Note: 1 credit of ECTS – 30 hours.

  • Audience loading – 66,7%, ExW – 33,3%.



^ 3. Eventual of whole studies of discipline «Clinical pharmacology»

The ultimate goals of educational discipline are formulated in accordance with educationally professional programs (EPP) and educationally professional features (EPD):

  • forming of the integral system of theoretical bases of clinical pharmacology;

  • study and estimation of pharmacodynamic and pharmacokinetic parameters of medications;

  • mastering of methodology of leadthrough of comparative estimation of different medications;

  • mastering of general methodology of choice of optimum medicinal medicine, its dose, way and mode of administration for a concrete patient for effective and safe medicinal therapy taking into account the state of patient;

  • mastering of principles of interaction of medications during complex application;

  • exposure and to forecast on the early stages of side effect of medications and leadthrough of the proper correction;

  • study of factors which promote the risk of development of side effect of medications and their combinations;

  • mastering of methods and criteria of estimation of efficiency and safety of application of concrete medicinal medicines during the leadthrough of complex therapy of different diseases.

As a result of study of clinical pharmacology a student must know:

  • pharmacodynamics and pharmacokinetics of medications of different pharmacological groups, factors which promote their change.

  • principles of interaction of medicinal medicines in the organism of patient.

  • principles of complex medicinal treatment of some internal diseases;

  • methods and criteria of estimation of clinical efficiency and safety of application of agents of different pharmacological groups;

  • principles of forecasting, criteria of display of possible side effects of different medications, methods of their correction and prophylaxis.



^ 4. The module «Clinical pharmacology» (all the hours – 45/1,5 credits)

(Tutorials – 30 hrs., ExW – 15 hrs.)

Ultimate goals of the module

Students must:

  • Be able to use pharmacodynamic and pharmacokinetic indexes for the estimation of efficiency and safety of medications, basic factors which influence on bioavailability, to understand the value of bioequivalence;

  • To use principles of control of efficiency and safety of medications, clinical and pharmacological aspects of the choice of adequate methods of control of efficiency and| safety of medications of different pharmacological groups;

  • To analyze the treatment sheets in relation to possible expedience of the combined therapy of concrete patient;

  • To determine the types of side actions of medicinal medicine and conduct the proper correction;

  • Be able to fill the map of «Report about side reaction/action of medications»

  • To determine kinds and character of interaction of medicinal medicines during the leadthrough of treatment.

  • To operate by clinical and pharmacological features of anti-inflammatory drugs in concrete clinical situations (personal features of pharmacodynamic and pharmacokinetic, interacting with other medicines, side effects, estimation of efficiency and safety) of glucocorticoids, Non-steroidal anti-inflammatory drugs (NSAIDs), basic anti-rheumatic agents;

  • To operate by clinical and pharmacological features of certain groups of antibacterial and antiviral agents personal features of pharmacodynamic and pharmacokinetic, interacting with other medicines, side effects, estimation of efficiency and safety of antibiotics, synthetic chemotherapeutic, antiviral, antiprotozoan agents);

  • To operate by clinical and pharmacological features of inhalative glucocorticoids, H1-blockers of histamine, anti-leukotrien agents, bronchodilatators, antitussive agents and expectorants (personal features of pharmacodynamic and pharmacokinetic, interacting with other medicines, side effects, estimation of efficiency and safety);

  • To operate by clinical and pharmacological features of antisecretory, antacids, prokinetics, spasmolysants, bile-expelling, enzymic, anti-diarrhea drugs and laxatives, hepatotropic drugs (personal features of pharmacodynamic and pharmacokinetic, interacting with other medicines, side effects, estimation of efficiency and safety);

  • To operate by clinical and pharmacological features of medications which are used for treatment of ischemic heart disease and arterial hypertension (personal features of pharmacodynamic and pharmacokinetic, interacting with other medicines, side effects, estimation of efficiency and safety);

  • To operate by clinical and pharmacological features of diuretics and medications, which are used for treatment of arrhythmias and heart insufficiency (personal features of pharmacodynamic and pharmacokinetic, interacting with other medicines, side effects, estimation of efficiency and safety);

  • To operate by clinical and pharmacological features of medications, which influence on hemostasis (personal features of pharmacodynamic and pharmacokinetic, interacting with other medicines, side effects, estimation of efficiency and safety);

  • ^ Be able to conduct the choice of medication, depending on a concrete clinical situation.



5 A structure of the module «Clinical pharmacology» and estimation of score for current educational activity (converting of traditional marks in score points; estimation in score points for implementation of individual tasks, if it is foreseen by an executable educational programme).


^ Number of the modules of /hours /credits

Amount of Intensional modules

Amount of practical studies (tutorials)

Traditional estimations (marks)

^ Score points for extracurricular work (ExW)

The least of score points*

5

4

3

2

Report of side effect

Yearly project

45/1,5

2

9

12

9

7

0

3

2

1

9

7

6

70

* the least of score points, which student must collect for current educational activity at the study of this module, to be accepted to pass an final module control.

^ THEMATIC PLAN OF TUTORIALS

on «Clinical pharmacology»




Name of theme

Amount of hours

1

Object and task of clinical pharmacology. Pharmacokinetics and pharmacodynamics. Interaction and side effects of medications.

3

2

Clinical pharmacology of anti-inflammatory drugs (glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), basic anti-rheumatic agents)

3

3

Clinical pharmacology of antibiotics, synthetic chemotherapeutic antibacterial drugs

3

4

Clinical pharmacology of antiviral, anti-protozoan and antihelminth medicines.

3

5

Clinical pharmacology of medications which are used in treatment of disorders of the airway conductance (inhalative glucocorticoids, H1-blockers of histamine, anti-leukotrien agents, bronchodilatators, antitussive and expectorants).

3

6

Clinical pharmacology of medications which are used for treatment of diseases of organs of digestion (antisecretory, antacids, prokinetics, spasmolysants, bile-expelling, enzymic, anti-diarrheal and laxatives, hepatotropic drugs)

3

7

Clinical pharmacology of medications which are used for treatment of ischemic heart disease and arterial hypertension

3

8

Clinical pharmacology of diuretics and medications, which are used for treatment of arrhythmias and heart insufficiency

3

9

Clinical pharmacology of medications which influence on hemostasis

2

10

Final module control

4

In All

30


The types of extracurricular work of students during studying

module «Clinical pharmacology»




Theme

Amount of hours

1.

Preparation to the tutorials of the module

9

2.

Individual work:

  • filling of «Report about side effect/action of medications»

  • Yearly project of students

4

Independent working with themes which are not included in the plan of tutorial

3.

Clinical pharmacology of analgetics. Treatment of pain

2

In All

15



^ Estimation of educational activity of students

Control forms and evaluation system are carried out in accordance with the requirements of the program of discipline and Instruction about the system of evaluation of educational activity of students at credit-module to the system of organization of educational process, Ukraine ratified by MH (2005)

An estimation for the module is determined as a sum of estimations of current educational activity (in score points) and estimation of final module control (in score points), which is proposed at the evaluation of theoretical knowledge’s and practical skills in accordance with lists, certain the program of discipline.

Maximal amount of score points, which is appropriated to the students at mastering each to the module (test credit), – 200, in a that number for current educational activity – 120 points (60%), as a result of module final control – 80 points (40%).

Current control is carried out in accordance with concrete aims on every practical employment. For control it is recommended to apply the followings agents of diagnostics of level of medicine of students: computer tests, situational tasks of ІІІ level, control of implementation of practical skills, are with subsequent interpretation of findings: analysis of treatment sheets, choice of optimum mean in a concrete situation.

^ Evaluation of current educational activity:

Weight of every theme within the limits of one module is identical and determined by the amount of themes in the module.

Estimation from discipline «Clinical pharmacology» is rating and determined taking into account current educational activity of student and estimations of mastering to them of the modules foreseen by the program. The current evaluation of students on the proper themes is conducted after traditional by a 4-point system («excellent», «good», «satisfactory», «unsatisfactory») with the subsequent converting in a multimark(rating) scale.

An estimation is «excellent» in the case when a student knows maintenance of employment in full, illustrating to the answer various examples; gives exhaustively exact and clear answers without any questions; lays out material without errors and inaccuracies; freely decides tasks and executes the practical tasks of different degree to complication.

An estimation is «good» for terms, when a student knows maintenance of employment and well understands him, answers for a question lays out correctly, consistently and systematic, but they not exhaustive, although on additional questions a student answers without errors; decides all tasks and executes practical tasks. feeling complications only in the heaviest cases.

An estimation «satisfactory» belongs to the student on the basis of his knowledge’s of all maintenance of employment and at the satisfactory level of his understanding. A student is able to decide the modified (simplified) tasks by additional questions; decides tasks and executes practical skills, feeling complications in simple cases; not able independently systematic to expound an answer, but on straight put questions answers correctly.

Estimation is «unsatisfactory» in the cases when knowledge and ability of student does not answer the requirements of «satisfactory» estimation.

^ Evaluation of independent work:

The evaluation of independent work of students, which is foreseen in a theme next to tutorial, is carried out during current control of theme on the proper audience employment. Evaluations of themes, which dart out only on independent work and not included in the themes of tutorials, and also individual independent work of students controlled on final module control.

Filling of «Report about side effect/action of medications», yearly project «Protocol of study of efficiency and safety of application of medications» and study of a 1 theme for the independent mastering belong to the independent work.

Every student gets the form of «Protocol...», what fills during work with a patient in extracurricular time (with determination of diagnosis, setting of plan of treatment, features of medications, possible cooperation). A yearly project seems in the next to last day of leadthrough of the module, defense takes place during the leadthrough of final control and estimated separately. Two filled «Reports about side effect/action of medications» seem on the next to last day of leadthrough of the module.

Count of current progress of students at the study of the module «Clinical pharmacology»:

Estimation «excellent» – 12 score points

Estimation «good» – 9 score points

Estimation «satisfactory» – 7 score points

Estimation «unsatisfactory» – 0 score points

^ Criteria of evaluation of students are at a study to the module

«Clinical pharmacology»

^ The module is «Clinical pharmacology»

ExW




Intensional module 1

Intensional module 2

№ themes

1

2

3

4

5

6

7

8

9

Maximal score point

12

12

12

12

12

12

12

12

12

12

For current educational activity a student can get 120 score points as maximum. This estimation is calculated by the increase of amount of score points which answer an estimation «excellent», on the amount of themes in the module with addition of score points for individual independent work (yearly project + protocol-report) (as maximum 12 score points).(12х9+12=120)

Criteria of evaluation of yearly project writing of which is foreseen at the study of the module «Clinical pharmacology»:

9 score points – written methodically right, without remarks;

7 score points – written methodically right, but separate sections not enough gone into detail;

6 score points – separate remarks take place in relation to working out in detail and sequence of features of sections;

0 score points – a chart is broken and rule writing of yearly project (in this case a student must rewrite a yearly project taking into account the remarks of tutor).

Criteria of evaluation of protocols-reports of the side effect of medications filling of which is foreseen at the study of the module «Clinical pharmacology»:

3 score points – filled methodically right, without remarks;

2 score points – filled methodically right, but separate sections are gone not enough into detail;

1 score point – separate remarks take place in relation to working out in detail and rightness of features of sections;

0 score points – a chart is broken and rule filling on the whole (in this case a student must rewrite a protocol-report taking into account the remarks of teacher).

The least of score points, which a student can collect at the study of the module, is calculated by the increase of amount of score points which answer an estimation «satisfactory», on the amount of themes in the module plus a minimum estimation (7) which a student can get for individual independent work: 7 х 9 + 7 =70 score points.

^ Final module control in the module «Clinical pharmacology»

Before final module control students which fully executed the program given to the module and got not less than 70 score points for current progress are assumed.

Final module control from foresees an answer for 20 questions of test control (from them 10 tests and 10 tasks), defense of yearly project, decision of situational task (practical skill) (analysis of treatment sheet) and answer for 2 questions of module orally.

A maximal amount of score points, which a student can get during module control, is 80, here estimation for test control – must make 15 score points (5 score points for tests, 10 for test problems tasks), for the decision of situational task – 15 score points, for defense of yearly project – 20 score points, an answer for the question of interview is 30 score points (15 score points for every question).

Test control consists of two types of evaluation: tests are made on the basis of knowledge of list of medications properties of which are controlled at completion of the module. Tasks of ІІ level of mastering (to the format «Step-2») are the second part of test control.

Criteria of evaluation of test control:

tests: 5 score points for a decision minimum 9-10 test tasks; 4 score points for a decision 8 test tasks; but 3 score points for a decision 6-7 test tasks.

Criteria of evaluation of test problems tasks:

10 score points for a decision 9-10 test problems tasks.

8 score points for a decision 8 test problems tasks.

7 score points for a decision 7 test problems tasks.

Maximally a student for test control can get 15 score points, minimum - 10 score points.

Criteria of evaluation of situational task - 15 score points are an answer on «excellent», 12 score points – answer for an estimation «good», 10 score points – estimation «satisfactory», 0 score points – answer not reckoned.

Criteria of evaluation of defense of yearly project - 20 score points are an answer on «excellent», 15 score points – answer for an estimation «good», 10 score points – «satisfactory», 0 score points – answer not reckoned.

Criteria of evaluation of interview: 15 score points – answer each question on «excellent», 12 score points – answer of each question on an estimation «good», 10 score points – answer for a 1 question on «satisfactory», 0 score points – answer not reckoned. (maximally - 30 score points, minimum – 20 score points).

Final control is considered reckoned, if a student collected not less than 50 score points (necessarily 10 score points for test control (3+7), 10 score points for the decision of situational task, 10 score points for defense of term paper, 20 score points for an answer for the question of interview).

^ An evaluation of discipline is «Clinical pharmacology».

Estimation from «Clinical pharmacology» is proposed to the students which the module is reckoned from discipline and they are passed a module control exam. Encouraging score points in decision of Vchena Rada can be added to the amount of score points from discipline to the students which have scientific publications or took the prize places for participating in an olympiad from discipline among the medical Universities of Ukraine et al.

^ Converting of middle amount of score points from discipline

«Clinical pharmacology» in estimations after the scales of ECTS

and by a 4-score(traditional)

^ A scale ECTS

On a national scale

A scale BSMU

(in score points)

A (excellent)

excellent

180-200

In (very good)

good

165-179

С (good)

150-164

D (good)

satisfactory

135-149

E (poor)

120-134

FX

unsatisfactory

with possibility of the repeated passing of control exam

70-119

F

unsatisfactory

with obligatory repeated course

1-69

The list of theoretical questions for training of students to the last control of the module of «Clinical pharmacology»


  1. Object and task of clinical pharmacology.

  2. Nomenclature of medications, «Law on medications». Determination of specific concepts of clinical pharmacology.

  3. Pharmacodynamics. Mechanisms of action of drugs.

  4. Receptors of cellular membranes: Pharmacodynamic aspects (nature of receptors, agonism and antagonism, partial agonists, competitive and noncompetitive agonists and antagonists).

  5. Rational dosage of drugs. Types of doses which are used in treatment of defeats of different organs and systems.

  6. Pharmacokinetics. Basic ways of absorption, ways of administration of medications.

  7. Distributing of medications in the organism of human. A clinical value of binding of medications with the proteins of plasma.

  8. Biotransformation of medications. Disorder of function of liver and metabolism of medications.

  9. Excretion of medications. Clearance.

  10. Pharmacokinetics. Indexes of pharmacokinetics.

  11. Pharmacokinetics. Bioavailability. Effect of the primary passing. Bioequivalence. Cumulation.

  12. Interaction of medications. Pharmacokinetic. Interaction of medications.

  13. Interaction of medications. Pharmacodynamic interaction of medications.

  14. Basic types of side effects of medications and mechanisms of their origin. Prophylaxis of complications of drug treatment. System of pharmacological supervision of WHO.

  15. Clinical pharmacology of NSAIDS, control of efficiency and safety.

  16. Clinical pharmacology of analgetics.

  17. Basic principles of anti-inflammatory hormonotherapy. Side effects of glucocorticods.

  18. Clinical pharmacodynamics of glucocorticoid, spectrum of application, control of efficiency and contraindications.

  19. Clinical pharmacology of immunomodulators and “basic” anti-rheumatic agents.

  20. Clinical pharmacology of interferons and drugs, which influence on their synthesis and activity, control of efficiency and safety.

  21. Clinical pharmacology of penicillins. Side effects. Complications.

  22. Clinical pharmacology of aminoglycosides. Side effects. Complications.

  23. Clinical pharmacology of cephalosporins. Side effects. Complications.

  24. Clinical pharmacology of macrolides, tetracyclines and chloramphenicols. Side effects. Complications.

  25. Clinical pharmacology of fluoroquinolones, lincosamides, glycopeptides. Side effects. Complications.

  26. Clinical pharmacology of sulfanilamides, nitrofurantoins, nitric imidazoles. Side effects. Complications. Control of efficiency and safety.

  27. Clinical pharmacology of antiviral agents. Classification. Side effects. Complications.

  28. Principles of rational choice, prescription, administration and dosage of antimicrobial agents.

  29. Clinical pharmacology of anti-protozoan agents

  30. Clinical pharmacology of antihelminth agents.

  31. Clinical trials. Phases of clinical trial of new drug.

  32. Clinical pharmacology of nitrates, spectrum of application, control of efficiency and safety.

  33. Clinical pharmacology of calcium channel blockers, control of efficiency and safety.

  34. Clinical pharmacology of beta-blockers, spectrum of application, control of efficiency and safety.

  35. Clinical pharmacology of antiatherosclerotic agents, spectrum of application, control of efficiency and safety.

  36. Clinical pharmacology of antihypertensive central agonists (agonists of central adrenergic and nonadrenergic receptors), sympatholytics, ganglionic blocking agents: control of efficiency and safety.

  37. Clinical pharmacology of alpha-adrenoblockers and peripheral vasodilatators, which are used in treatment of arterial hypertension, control of efficiency and safety.

  38. Clinical pharmacology of agents which influence on the renin-angiotensin system; control of efficiency and safety.

  39. Clinical pharmacology of thiazide and thiazide-type diuretics and inhibitors of carbonic anhydrase, spectrum of application, control of efficiency and safety.

  40. Clinical pharmacology of loop and osmotic diuretics, spectrum of application, control of efficiency and safety.

  41. Clinical pharmacology of potassium-sparing diuretics, control of efficiency and safety.

  42. Clinical pharmacology of cardiac glycosides. Clinical and pharmacological features. Control of efficiency and safety. Intoxication by cardiac glycosides.

  43. Clinical pharmacology of nonglycoside inotropic agents, spectrum of application, control of efficiency and safety.

  44. Principles of prescription of drugs during pharmacological therapy of chronical heart insufficiency.

  45. Clinical pharmacology of antiarhythmical agents. Sodium channel blockers. Agents which prolong an effective refractory period and potential of action. Control of efficiency and safety.

  46. Clinical and pharmacological features of beta-blockers, calcium channel blockers, cardiac glycosides, adenosine as antiunrhythmical agents. Control of efficiency and safety.

  47. Clinical pharmacology of fibrinolytics and antiplatelet agents. Control of efficiency and safety.

  48. Clinical pharmacology of direct anticoagulants and indirect anticoagulants, control of efficiency and safety.

  49. Clinical pharmacodynamics of basic groups of medicine which are used for treatment of disorders of the airway conductance, control of efficiency and safety.

  50. Clinical pharmacology of anti-inflammatory agents which are used for treatment of bronchial asthma, control of efficiency and safety.

  51. Clinical pharmacology of H1(histamine)-receptors blockers, control of efficiency and safety.

  52. Clinical pharmacology of theophyllines (methylxanthines), control of efficiency and safety.

  53. Clinical pharmacology of antitussive drugs and agents, which stimulate expectoration (expectorants), control of efficiency and safety.

  54. Clinical pharmacology of agents, which repress the acid-forming function of stomach (antisecretory), control of efficiency and safety.

  55. Clinical pharmacology of agents, which are used in antirecurrent therapy of ulcerous disease, control of efficiency and safety.

  56. Clinical pharmacology of antiemetic agents, prokinetics, spasmolysants.

  57. Clinical pharmacology of laxatives and anti-diarrheal agents.

  58. Clinical pharmacology of choleretics and agents which use for treatment of cholelithiasis.

  59. Clinical pharmacology of hepatotropic agents (hepatoprotectors).

  60. Clinical pharmacology of agents for enzymic substitutive therapy and agents for treatment of dysbacteriosis, control of efficiency and safety.


^ LIST OF PRACTICAL SKILLS

for final control of the module «Clinical pharmacology»


  1. To collect and analyze pharmacological anamnesis of a patient.

  2. To conduct the analysis of the treatment sheet and conduct their correction.

  3. To choose optimum medicinal medicine for treatment of different nosologies taking into account its pharmacodynamic and pharmacokinetic properties, possible interaction and possible side effects.

  4. To choose an optimum medical form, way of introduction, chart of dosage of medication for a concrete patient.

  5. To discover and forecast on the early stages the side effect of medications and to conduct its correction.

  6. To discover and estimate effects from interaction of medications, in good time to conduct a correction and replacement of medicinal medicine which caused an undesirable effect.

  7. To define the criteria of efficiency of treatment and control efficiency of pharmacological action of medication.

  8. To define the criteria of safety of action of medication on an organism at the use of him in treatment of concrete patient.

  9. To appoint additional laboratory and instrumental research with the purpose of estimation of action of medication in the organism of concrete patient.

  10. To design a medical document (treatment sheet, «Report about side action/reaction of medications».

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