CURRICULUM

DM Clinical Pharmacology
(3 year course)

Maharashtra University of Health Sciences,

Nashik

POSTGRADUATE TEACHING/TRAINING COURSE FOR D.M CLINICAL PHARMACOLOGY DEGREE SECTION -1 Goals: 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 The comprehensive training in clinical pharmacology and therapeutics will be able to make the clinical pharmacologist achieve following objectives and serve the following functions: 1. Regulatory affairs: Decide whether animal data on drug are adequate to justify its administration to humans. To decide whether therapeutic trials justify the release of the drug for general use To develop and conduct monitoring programmes Pharmacovigilance To advise on restrictions on availability of drugs or their withdrawal from market To participate in National Drug Authority Functions 2. Academic and hospitals: Teaching and training of medical graduates in clinical pharmacology & therapeutics Patient care through drug problem oriented consultation and pharmacotherapeutics rounds Drug information Drug formulary and standard treatment guidelines Therapeutic drug monitoring Drug utilization and pharmacoepidemiological studies Adverse drug reaction monitoring Clinical trials Pharmacoeconomics Promoting rational drug use Developing and implementing antibiotic use policies based on local conditions Pharmacovigilance Functioning of Ethics Committees, Drugs and Therapeutic Committees 3. Pharmaceutical industry: New drug development Clinical trials Bioequivalence studies Drug information Pharmacovigilance

SECTION II Departmental objectives: At the end of the course the DM Clinical Pharmacology trainees shall be able to: 1. integrate essential principles of basic medical sciences with an understanding of the actions of drugs in the whole body and their therapeutic applications. 2. use drugs optimally in the prevention, diagnosis and treatment of disease. 3. Assess the benefits and risk of therapeutic decisions in patient management. 4. review critically therapeutic decisions in patient management. 5. initiate an effective, safe and affordable drug treatment in individual patient with common diseases based on a critical evaluation of clinical pharmacological and therapeutic principles and evidence of clinical effectiveness and safety. 6. evaluate drug treatment, identify harmful effects of drugs and know when to adjust, continue or stop drug treatment. 7. analyze risk benefit of drug treatment and promote the rational use of drugs. SECTION III Teaching / Learning Programme i) Admission: Admission to the course will be through an All India level entrance exam conducted under the aegis of DMER, Maharashtra. Eligibility criteria for admission: Essential: 1. M.B.B.S. degree from recognized university or institution 2. M.D. degree in Pharmacology from a recognized university or institution Institutional requirements for conducting DM course: 1. The institute should be imparting post graduate medical training and education 2. Institution having independent department of Clinical pharmacology and therapeutics 3. Having all medical specialty units 4. Clinical research ward under department of clinical pharmacology 5. Fully equipped independent pharmacodynamic and pharmacokinetic laboratories 6. Attached laboratory for drug analysis, biochemical, microbiological and clinical pathological investigations 7. Library with books and journals on clinical pharmacology and allied medical specialties. SECTION IV Duration of the course: The total duration of the course should be for 3 calendar years. During first 6 months of the course, the candidates will go through a general orientation course. The candidates will work in different departments of medical specialties and hospital attached laboratories. In the subsequent period of 2 1/2 years, the candidates will have training in the Department of clinical pharmacology and will be exposed to the working of the department. The training both in theory and practical will be offered in: 1. General clinical pharmacology 2. Pharmacological principles of therapeutics and drug evaluation 3. Systemic clinical pharmacology During the period of training, the candidate will be required to maintain a day- to- day work log book. Candidates will be required to produce performance record (Log Book) containing details of day to day work done by them, duly certified by the supervisor / guide at the time of Practical examination.

The candidate will be required to visit a pharmaceutical industry and / or institutions carrying out basic drug research and office of drug control authority, for a period of one week each. Candidate is required to complete a research project in clinical pharmacology and therapeutics which will be submitted as thesis / dissertation at least 6 months prior to the final examination, for evaluation by the examiners. SECTION-V 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

Methodologies for drug development, Drug evaluation and Clinical trials

Drug Development: a) Rationale/Need for a new drug b) Source of new drugs and compounds for screening as a potential drug c) General Pharmacological and systemic screening preclinical / experimental d) Toxicity studies Teratology, carcinogenicity, mutagenicity e) Role of government institutes, pharmacological housed, university centers of excellence and the government in drug development collaborative effort Assessment of Preclinical data:a. Animal Pharmacology- effectiveness and safety b. Assessment of pre clinical data for adequacy of toxicity and efficacy studies as per new drug development regulations for clinical evaluation c. Pharmacokinetic studies in animals d. Selection of initial human dose from animal data e. Assessment of cost, benefit and risk ratio f. Extrapolation of animal data to clinical situation Evaluation of drug actions in man ICH and GCP guidelines, IRB, Ethics committee Emergence of new drugs, drug design and discovery Legislatory control of new drugs The drug regulatory authorities point of view. Pharmacological principles of therapeutics and systemic clinical pharmacology Pharmacological basis of drug therapy of common and important diseases. Clinical evaluation of difference classes of drugs. special problems and pitfalls and protocol designing of antianginal, antihypertensive, antiarrhythmic , diuretic, antiepileptic, hypnotic, analgesic, anti-inflammatory, neuropsychiatric disorders, antiasthmatic, drugs for peptic ulcer , anti- diabetic , antifertility , anti-cancer , chemotherapeutic agents , antiemetic , antiprotozoal , vaccines Ability to assess critically commercial claims for established and new drugs Understanding of the pharmaceutical industrys achievements and educational role Developing Clinical Trial Designs Developing and writing Clinical Protocols Planning special types of clinical trials Planning and conducting a single clinical trial Nonmathematical approach to statistics and data processing Fundamental principles, considerations, and techniques in the Interpretation of Clinical Data Interpretation of Safety and Efficacy Data Interpretation of Data from Special Trials, Modalities and Populations Issues and Problems of Clinical Data Interpretation Publishing Clinical Data and Evaluating Published Literature Planning and Conducting Multiple Clinical Trials Management of Multiple Clinical Trials Types of clinical studies envisaged: a) Retrospective Vs Prospective trials b) Single center Vs Multicentre trials c) Fixed dosage Vs variable dosage Protocol designing: Broad principles and the role of industry in protocol designing Phases of clinical trials: Phase I, II, III and IV. Pre clinical, clinical requisites for Phase I, II, III and IV trials and their clinical significance Multicentric trials:

o The placebo o Randomization o Withdrawals and dropouts of a study subjects o Washout period International implications: Acceptance of data obtained in one country by the drug regulatory agency of another country for use of drug in another country (racial/genetic/nutritional differences) Drug regulations of India and some other countries Role of World Health Organization and the International Drug Monitoring Center Special features of clinical trials with plant products Ethical aspects preclinical requisites Preparation and use of plant products Advantages and disadvantages Special problems in standardization of samples, selection of control etc. Collaboration with practitioners of alternative systems medicine General problems in organization and carrying out clinical trials Ethical and legal aspects of clinical trials a.Ethical aspect of carrying out a clinical trial b.Formation of an ethical committee and its approval for clinical evaluation c.Legal aspects of carrying out clinical trials d.Informed consent of subject written / verbal statement e.Subjects for clinical trials f.Investigator g.Other aspects i. Drugs and the fetus ii. Payment to volunteers iii. Compensation to subjects for injury during participation in drugs trials iv. Insurance to investigator v. Administration of drugs by non medical personnel vi. Assessment of risk and benefit vii. Historical perspectives in human experimentation experiments on prisoners at concentration camps, Helsinki Declaration, Nuremberg code.

Systemic Clinical Pharmacology and Therapeutics and Recent Advances

Using drugs effectively: Choice of therapy When not to prescribe Identification of therapeutic problem lists Preparation of planned therapeutic regimens Drug use in multiple illnesses Combination therapies, tailored therapy Reading and understanding prescriptions Instruction in prescribing techniques Awareness of iatrogenic disease Principles of using approved names vs. brand names Non Text book information sources needed for effective uses of drugs e.g. National Formulary, Drug and Therapeutics Bulletin, Prescribers Journal Communication with patients about their medication Assessment of compliance problems and methods of enhancing compliance

 Relationship between compliance and understanding Essential drugs Rational drug use Evidence based medicine Pharmacoeconomics Drugs and the autonomic nervous system: Directly and indirectly acting cholinomimetics Muscarinic and nicotinic receptor blockers a/b adrenoceptor agonist /antagonists indirectly acting sympathomimetics investigation of drug response in man the action of beta blockade in volunteers the actions of nitrates and nicotine in man drugs acting on the human eye anticholinergic , cholinergic, sympathomimetic Drugs acting primarily on the central nervous system antidepressants anti- parkinsonian agents Anxiolytics Sedatives/hypnotics Anti-convulsants Anti-spastics CNS stimulants Appetite suppressants Drugs of dependence, alcohol Analgesics and pain control Drugs for migraine Neuroleptics Drugs in affective disorders Alzheimers disease Drugs and the cardiovascular system and blood: Anti-hypertensives Anti- anginals Drugs used in heart failure and shock Anti- dysrrhythmics Diuretics Lipid lowering drugs Drugs acting on the kidney: Diuretics Anti- diuretics Drugs affecting urine pH Uricosuric agents Drugs acting on the respiratory system: Bronchodilators Inhibitors of mast cell mediator release Anti- inflammatory steroids

Drugs for infection: Antibacterial Antiviral-including antiretrovirals - principles of vaccination Anti malarial Antifungal Antiprotozoal and antihelminthic Cancer chemotherapy and immunosuppressive drugs Neoplastic cell burden and principles of therapy Cell cycle specific and non specific agents Alkylating agents, antimetabolites, plant alkaloids, antibiotics, cisplatin, nitrosureas, hormonal agents Drugs affecting the GI tract Autacoids Ulcer healing drugs Anti-spasmodic Anti- diarrhoeal drugs Laxatives Motility stimulants Anti- inflammatory Anti- emetic Drugs and the blood Drugs for anaemias Anti- platelet agents Anti- coagulants and fibrinolytic agents Drugs and endocrine systems (diabetes, thyroid disease, adrenal disorders, hypothalamus and pituitary disorders, bone metabolism) Adrenocortical steroids, their analogues and drugs affecting their release Thyroid and anti- thyroid drugs Growth hormone and drugs affecting its release Drugs affecting blood sugar Drugs affecting Ca2+ homeostasis Vasopressin and its analogues Drugs and reproduction Gonadal steroids, their analogues and drugs affecting their release Fertility drugs Contraceptive drugs Oxytoxics and tocolytics Drugs suppressing lactation Autacoids and anti- inflammatory drugs Aspirin, cyclo-oxygenase inhibitors, non-steroidal anti- inflammatory and disease modifying drugs Eicosanoids, prostaglandins, thromboxane, leucotrienes and antagonists Corticosteroids Cytokines and anti- cytokines Histamine, serotonin, kinins, platelet activating factor and antagonists Management of pain Principles of pain relief Analgesics opioid and non-opioid Techniques of analgesic administration

Miscellaneous Pre-anaesthetic medication General anaesthetics, local anaesthetics Skeletal muscle relaxants Surgical prophylaxis PRACTICALS

Pharmacodynamic exercises:
A) Central Nervous System: Experiments to be conducted: 1. Evaluation of analgesic (NSAID) agent on healthy volunteer by using pain model Ischemic pain (Sphygmomanometer) model 2. Evaluation of CNS stimulant (caffeine) and CNS depressant (Benzodiazepine) in healthy volunteer, using paper and pencil method (six letter cancellation test, digital symbol substitution test(DSST) , card sorting test , finger tapping test, choice reaction time(CRT), Critical flicker fusion threshold test(CFFT) , Visual analogue scale (VAS) Demonstration to be observed Recording of EEG, EMG, EOG, MRI, CT (fundamental principles) B) Cardiovascular system: 1. Effect of drug on blood pressure and heart rate 2. Evaluation of beta adrenergic blocking agent (using exercise induced tachycardia) in healthy volunteer 3. Demonstration of effect of drug on cardiovascular refluxes- cold pressor test, table tilting test and Valsalva maneuver 4. Recording of 12 lead ECG and calculation of heart rate, PR- interval ST segment, QT interval, QTc and QTc dispersion in healthy volunteer. 5. Interpretation of classical ECG changes associated with MI, Cardiac hypertrophy, cardiac arrhythmias. Demonstration to be observed 1. Echocardiography 2. Treadmill test- exercise tolerance test 3. Coronary angiography 4. Ambulatory BP, Random zero BP and holter monitoring C) Respiratory system: Recording of pulmonary function using Spiro meter and peak flow meter in healthy volunteers Demonstration of bronchodilatory response in asthmatic patients by PFT

Pharmacokinetic exercises
1. Pharmacokinetic study: Single dose pharmacokinetic study with paracetamol in healthy volunteers 2. Pharmacokinetic study of single dose acetylsalicylic acid in healthy volunteers 3. Estimation of antiepileptic drugs Demonstration to be observed 1) TDM of antiepileptic drugs, cyclosporine, drugs of abuse digoxin, lithium,antibiotics

Miscellaneous:
Pharmacoepidemiological studies Prescription monitoring ADR monitoring Drug utilization studies in OP and IP patients Development of standard treatment guidelines for one clinical condition Pharmacoeconomic analysis Methods PG students are encouraged to largely carry out self learning. They are expected to actively seek knowledge and skill on their own initiative. Sound knowledge of systemic pharmacology including pharmacodynamics and kinetics and therapeutics of post graduate level is to be acquired entirely by self study and by participating in various teaching activities of the department. The following organized learning experiences should be provided to the students: 1. Lectures, group discussions and seminars: These will be held once a week and will include the lecture delivered by faculty members of CPT department and other allied disciplines. Topics of common interest to PGs will be covered in the programme. (Appendix). PG seminars will be held once a week which will be presented by PG students. Time table for these programmes will be drawn every six months and each PG student should present minimum six seminars every year. 2. Journal clubs: Journal clubs will be held once a week and each student has to present and discuss at least six therapeutic problems in a year. Programme for this will be drawn six monthly. 3. Therapeutic problems discussion: This will be held once a week and each student has to present and discuss at least six therapeutic problems in a year. Programme for these will be drawn six monthly. 4. Practical exercises: Students are required to carry out the practical exercises once a week under the guidance of faculty member. The exercise will be discussed with the faculty member theoretically in detail before performing the same. Students will be required to carefully record all the observations and same has to be recorded on exercise note book. Students are required to discuss the findings and the interpretation of the results of each exercise with the faculty member and are required to take the signature of the faculty member in charge on the exercise note book. The suggested practical exercised to be carried out or observed by the student are listed in the Appendix. 5. Thesis or dissertation: Every PG student will be required to carry out the research work under the supervision of his guide in the field of Clinical Pharmacology and Therapeutics. The thesis work can be carried out by the student jointly with other departments and the faculty from other departments can be opted as co-guides. The topic of thesis and the proposal will be discussed by the student with all the faculty members and will require approval from the institutional review committee as the case may be. The acceptance of thesis will be a prerequisite for the candidate to be allowed to appear in the written and practical examination. Student is required to submit the Thesis for the review by the external examiners at least 6 months before the schedule date of the examination. 6. Departmental clinical research work: The PG student will be involved in various clinical research works being undertaken in the department by the faculty members. Each student is required to participate at least in one research project every year. Teaching: The PG students are to participate in all aspects of teaching, specially practicals, demonstrations and tutorials. During their tenure, they will be working and under faculty members on rotation basis as per the allotment of the teaching schedule. The candidates should participate in the teaching programme for paramedical courses offered by the institute like nursing and physiotherapy.

Intradepartmental postings: Every PG student should be posted by rotation to the different sections / laboratories of the Clinical Pharmacology department like analytical lab, pharmacodynamic lab, pharmacokinetics and TDM (Therapeutic Drug Monitoring) labs, OP follow up clinic, ADR monitoring cell and drug information unit. A record of the observations made and lessons learnt should be maintained by the students. Posting in allied disciplines: During first six months of the course, the student will be posted and will go through a general orientation course in different departments of medical specialties and hospital attached laboratories. The schedule for these posting should be drawn every year in consultation with these departments. A log book should be maintained by the PG student of the work done during these postings and duly certified by the heads of the respective departments. Ward rounds: In consultation with major clinical departments arrangement will be made that the PG students of clinical pharmacology attend the ward rounds to get an exposure to the trends in the use of drugs, prescribing practices, adverse drug reactions, drug interactions etc. The student will be required to have a training in emergency and casualty medicine department to have a training in management of medical emergencies like respiratory failure, anaphylactic shock etc, including cardiopulmonary resuscitation procedures . A log book of the ward rounds attended and important observations made should be maintained by the PG. Conferences: The PG students should be encouraged to attend national/ regional conferences. Attendance at a minimum one conference during the 3 year course is mandatory. Credits should be given for attending more conferences and making poster/ oral presentations at these conferences. Workshops / updates: Workshops and updates on various aspects of pharmacology, clinical pharmacology, and therapeutics including experimental and clinical trial methodologies should be organized by different departments by rotation on national / regional basis. Intensive and hands on training should be provided to the PG students in these workshops/ updates. Visit of PGs to a pharmaceutical manufacturing /R&D facility and office of Drug Regulatory Authorities should be organized. SECTION VI Thesis/dissertation: the thesis /dissertation to be sent to two external examiners at least 6 months prior to commencement of the final DM examination. The examiners will submit their report to the University and recommend its acceptance/ modification/ rejection. The specific comments of the examiners should be communicated to the candidate and the guide. In case modifications are suggested these should be carried out and thesis resubmitted. In case of rejection of the thesis, the entire work, preferably on a new topic, has to be done by the candidate and thesis submitted to the University for processing a fresh. When the thesis has been accepted the candidate will be allowed to appear in the examination. The candidate will make a brief presentation about his thesis before the examiners and answer any questions asked by them. Marks will be awarded by the examiners on the basis of the quality of the thesis as well as the presentation made by the candidate. Log book: Credits are to be awarded on the log book of the student in which he /she records the details of teaching assignments , work done during posting in various labs / sections of the department as well as posting to other basic sciences/ clinical departments, ward rounds etc.

Leave: 30 Earned leaves in 1st year 36 Earned leaves in 2nd year 36 Earned leaves in 3rd year In addition the candidate can avail 6 casual leaves per semester. Attendance Since it is a resident in house work as you learn programme, it is desirable that candidates should have 100% attendance to enable this objective to be achieved. However a minimum of at least 80% attendance would be required before they are allowed to appear for the examination. EVALUATION (As per Direction No. 01/2008 dtd. 26/05/2008 & practical scheme is as per revised
practical marksheet.)

SECTION VII BOOKS RECOMMENDED: 1) Guide to Clinical Trials Bert Spilker, Raven Press, New York 2) Patient compliance in medical practice and clinical trials Bert Spilker, & Joyce Cramer, Raven Press 3) Data collection forms in clinical trials Bert Spilker, and John Schoenfelder Raven Press 4) Methodology of Clinical Drug Trials Alain Spriet, Dupin Spriet, Pierre Simon. Karger Publisher. 5) Techniques of Patient oriented research Charles Y C Pak, Perrie M Adams. Raven Press, New York. 6) Designing Clinical Research, Stephen B Hulley, Steven R Cummings. Williams & Wilkins 7) Drug treatment by Avery, ADIS publications. 8) Therapeutic Drugs Sir Collin Dollery , Churchil Lilvingstone. 9) Drugs in use Lina J Dodds.The pharmaceutical press. 10) Drug interaction Facts. David S Tatro. Facts and Comparison 11) Pharmacokinetics Made Easy. Donald J Birkett. The McGraw Hill Company Inc. 12) Clinical Pharmacokinetics Concepts and applications.Malcom Rowland. B.I.Waverly Pvt Ltd. 13) Clinical Pharmacology. DR.Laurence.Churchil Livingstone 14) Pharmacoepidemiology. Brain L Strom. Wiley Publishers. 15) Biostatistics a foundation for analysis in the health sciences. Wayne W Daniel. Wiley Publishers 16) Principles of Pharmacology Basic concepts and clinical Applications .Paul L Munson Chapman & Hall. 17) Integrated Pharmacology. Page .Curtis Mosby Publishers 18) Conns Current Therapy. W B Sanders company 19 Davidsons Principles and practice of Medicine. C R W Edwards. Churchil Livingstone 20) Pulmonary and Antiallergic drugs. Delvin P John. Wiley & Sons 21) Patient package insert as a source of drug information. Bogaert Marc etal. Excerpta Medica 22) Introduction to drug metabolism .Gibson G, Gordon and Skett Paul. Chapman and Hall. 23) Techniques of patient oriented research. Pak Y , C. Charles , Akams M Perrie. Raven press 24) The Broad range of clinical use of Phenytoin. Barry H Smith. Dreygus Medical Foundation

25) Clinical Pharmacy and Therapeutics. Walker Roger and Edwards Clive. Churchil Livingstone 26) Pharmacology. Goth Andrews, Vessel S Elliot. C.V. Mosby Company 27) Modern Pharmacology. Craig R Charlges, Stitzel E Robert. Little Brown Company. 28) Drug Induced liver disease. Farrel C Geoffrey. Churchil Livingstone 29) Human Pharmacology. Brody M Theodore et al.C.V. Mosby. 30) Principles of Clinical Toxicology. Thomas A, Douglas J Bricker. Raven Press. 31) Cardiovascular Drug Therapy. Messel H Franz. W.B. Sanders. 32) Assessing Causes of Adverse Drug Reactions. Vanulet Jan. Academic Press Subsidiary of Hart court Bruce Jovenic Publishers 33) Handbook of Clinical Research. Liyod Julia. Churchil Livingstone 34) Basics and clinical Pharmacology. Katzung G Bertram. Appleton & Lange 35) Drugs in Pregnancy and Lactation. Bridges G. Gerald et al .Williams and Willkins 36) Cardiovascular Pharmacology and Therapeutics. Bramah W Singetal. Churchil Livingstone 37) Meylers Side effects of Drugs. Dukes MNG. Elseiver Publications 38) Evaluations of Drug Interactions Shinn F Arthur & Shrewsbury P Robert. C.V. Mosby Company 39) AMA Drug evaluations. AMA division of drugs .W.B. Sanders Company 40) Clinical Toxicology. C.J. Poison et al. Pitman Publications 41) Board Review series Pharmacology. Rosenfeld. Williams & Wilkins. 42) Manual of antibiotics and infectious Diseases. Conte. Williams & Wilkins 43) Clinical Pharmacology made Ridiculously Simple. Olson. McGraw Hill 44) Topics in Clinical Pharmacology and Therapeutics. Maronde F Robert. Springer Veilag 45) Goodman & Gilmans The Pharmacological Basis of Therapeutics. Joel G Hardman. 46) Principles of Internal Medicine. Harrison. McGraw Hill 47) Annual Review of Pharmacology and Toxicology 48) Year Book of Drug Therapy LIST OF JOURNALS RECOMMENDED: 1. British Journal of Clinical Pharmacology 2. European Journal of Clinical Pharmacology 3. Clinical Pharmacology and Therapeutics 4. Drugs 5. Pharmacotherapy 6. Journal of Clinical Pharmacology 7. International Journal of Clinical Pharmacology 8. Annals of Pharmacotherapeutics 9. Applied Clinical Trials 10. Postgraduate Medical Journal 11. The Lancet 12. American Journal of Medicine 13. Annals of Internal Medicine 14. British Medical Journal 15. New England Journal of Medicine 16. Journal of Cardiovascular Pharmacology 17. Clinical Pharmacokinetics 18. Journal of Chromatography and Biomedical Applications 19. Indian Journal of Pharmacology 20. Indian Journal of Experimental Biology 21. Indian Journal of Medical Research 22. Archives of Internal Medicine 23. Drug Safety