DM Clinical Pharmacology
Course
In Nashik
Description
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Type
Course
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Location
Nashik
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Duration
3 Years
Facilities
Location
Start date
Start date
Reviews
Course programme
DM Clinical Pharmacology
Goals of DM Clinical Pharmacology Course can be broadly divided into 4 main areas where
the clinical pharmacologist will be able to contribute:
1. Academics - Teaching, training and research in clinical pharmacology
2. Regulatory affairs - Drug registration, control of clinical trials, adverse drug monitoring,
drug licensing, drug pricing and drug information.
3. Pharmaceutical industry - Clinical trials, bioequivalence studies, drug approvals, new
drug development and post marketing surveillance, drug development.
4. Patient care: To advice clinicians on pharmacotherapeutics, drug-drug interactions,
Pharmacovigilance, Evidence based medicine, ethics and clinical research methodology
Course Content:
Basic principles of clinical pharmacology:
1. Introduction:
The clinical Pharmacologist:
- Definition.
- Role of the clinical Pharmacologist in institutions / National / International setting.
- Centers for clinical pharmacology - training / research.
a) Definition and scope of clinical Pharmacology
b) History and development of clinical Pharmacology
c) General principles in clinical Pharmacology
d) Aims of a clinical trial
e) Problems in clinical trials
2. Principles of drug actions; molecular mechanisms of drug action including:
a. Receptor theory and targets of drug action
b. Agonists and types of antagonism
c. Cellular basis of quantitative pharmacology
d. Principles of structure - activity and dose -response relationships
e. Mechanism by which drugs modulate signal transduction pathways
f. Interactions between drugs and ion channels
g. Modulation of gene expression by drugs
h. Receptor - independent mechanisms of drug action e. g. inactivation of enzymes,
interactions with structural components of the cell
i. Active and passive mechanisms by which drugs cross cell membranes
j. Molecular basis of inadequate or excessive drug actions including drug interactions
k. Mechanisms of termination of drug actions (e.g. uptake into cells; degradation)
3. Pharmacokinetics and Pharmacodynamic
a. Kinetics of absorption, distribution, biotransformation and excretion of drugs - use of
radioisotopes
b. Studies on bioavailability / bioequivalence of drugs new delivery system
c. Interaction between the drug and other drugs, physiological systems, disease and
environment.
d. Role of a drug assay centre
e. Studies with single and multiple doses and multiple drug combination
f. Pharmacokinetic parameters, mathematical models single and multiple compartments
g. Molecular basis of drug action
h. Mechanism of drug action
i. Dose response relationship and effective therapeutic dose
4. Principles of Drug Therapy:
A. Principles of drug administration, drug action, and pharmacokinetics
i. Routes of administration
ii. Mechanisms of absorption, distribution, metabolism and excretion of drugs
iii. Desired and undesired actions of drugs
iv. Principles of drug interactions and adverse drug reactions; emphasis on the global
actions of the major drug groups in the whole body- multiple actions of single
agents
v. Drug allergy - mechanisms and common examples of four types of allergic
response; common clinical presentations and their management
vi. Monitoring of plasma / tissue concentrations of drugs- when are these necessary;
limitations
B. Variability in human response to drugs and influence of disease processes
i. Drug handling and prescribing in the elderly, infants and children: altered
pathophysiology special problems with polypharmacy
ii. Drug usage in pregnancy and in breast-feeding women: special concerns for drug
toxicity, drugs of choice in common diseased
iii. Prescribing for patients with renal or hepatic disease: altered pharmacokinetics and
dynamics; drugs to be avoided; drug induced nephrotoxicity and hepatotoxicity
iv. Influence of other concurrent diseases- e.g. asthma, gout, diabetes, hypertension,
porphyria, hypercholesterolaemia, heart failure- on prescribing; and precipitation of
the conditions by drugs
v. Pharmacogenetics: implications for altered or unusual drug handling, drug efficacy
or toxicity, common and dangerous clinical examples, gene therapy
C. Knowledge of adverse drug reactions and interactions:
i. Epidemiology; mechanisms; pharmacologic and non-pharmacologic
ii. How to recognize, how to avoid
iii. Voluntary reporting systems, post- marketing surveillance
D. Elements of drug abuse, toxicology and poisoning
i. Overdose and addiction problems; epidemiology. recognition
ii. Clinical toxicology, nature of toxic response
iii. Food toxicology, additives, contaminants and components
iv. Forensic aspects of poisoning
v. Management of common poisons (e.g. salicylate, paracetamol...)
5. Drug usage in special clinical condition:
a. Disease states
b. Renal failure
c. Hepatic failure
d. Cardiac failure
e. Different physiological states: neonatal, paediatric, geriatric, and pregnancy subjects.
6. Drug monitoring:
a.Monitoring drug therapy: How, why and when?
b.Drug surveillance, including post marketing drug
c. ADR monitoring.
BIOSTATISTICS:
Statistical principles underlying clinical trials, data handling and role of biostatistician
Sample size calculation
Types of variables
Type 1 error and type 11 errors
Parametric and nonparametric tests
Clinical significance versus statistical significance
Correlation and regression analysis
Probability
Confidence intervals
Intention to treat analysis
Randomization
DM Clinical Pharmacology