RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1 NAME OF THE CANDIDATEADDRESS

DIPTARUP BISWASHouse no.578, 15th main, 5th crossSrinivasnagar, SBM colony Bangalore -50

PERMANENT ADDRESS.DIPTARUP BISWASc/o Mr. CHANCHAL KUMAR BISWAS216/1 N. N. Road, Dum DumNagerbazarKolkata – 700028

2 NAME OF THE INSTITUTION AL-AMEEN COLLEGE OF PHARMACYHosur Road, Near to Lal Bagh Main GateBangalore - 560027

3 COURSE OF STUDY AND SUBJECT

Master of Pharmacy in Pharmaceutical Marketing and Management

4 DATE OF ADMISSION 13/5/2008

5 TITLE OF THE TOPIC:

“ MAKING A LAUNCH STRATEGY FOR A NEW BRAND OF AN EMERGING COMPANY IN THE INTERNATIONAL AND DOMESTIC MARKET”

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BRIEF RESUME OF THE INTENDED WORK:

6.1 NEED FOR THE STUDY :

Emerging from a highly protected economy and an insulated business environment, many

companies in India have come a long way in their quest to become global players. Indian

companies have started to venture into the global business arena by acquisition, joint venturing

and direct investment. Although the opportunities for companies to enter and compete in foreign

market are significant, the risks can also be high.(1)

Among these companies, pharmaceutical organizations in India are also competing in

the global market. There are several factors which are responsible for drawing more and more

companies into the international arena:

The company discovers that some foreign markets present higher profit opportunities

than the domestic market.

The company needs a large customer base to achieve economies of scale

The company wants to reduce its dependence on any one market

Global firms offering better products can attack the company’s domestic market.

The company might want to counterattack these competitors in their home markets.(1)

An emerging company who wants to compete in the global sector has an opportunity to launch

its own brand when therapeutic substances go off patent.

Before keeping step in the global arena with its product offering, there are lots of criteria

which have to be taken in consideration by a company to launch its new brand in one or two

specific segment to make it a success. Such as….

Country analysis – The company must decide how many countries to enter and how fast

to expand. The company must also decide on the types of countries to consider.

Attractiveness is influenced by the product, geography, income and population,

epidemiology, political climate TRIPS and other factors

Risk analysis – Before making a decision to go abroad, the company must weigh several

risks, such as the company might not understand foreign customer preferences, they

might not understand the foreign country’s business culture or know how to deal

effectively with foreign nationals, the company might underestimate foreign regulations

and incur unexpected costs, foreign country might change its commercial laws, devalue

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its currency or undergo a political revolution and expropriate foreign property. (1)

Cultural aspects – Every group of people or society has a culture because culture is the

entire social heritage of human race. When designing a product, the style, uses and other

related marketing activities must be made culturally acceptable. Culture is pervasive in

all marketing activities such as pricing, promotion, channels of distribution, product,

packaging and styling.(2)

Customer psyche – The marketing concept holds that consumer needs vary and that

marketing programs will be more effective when they are tailored to each target group.

The company should review the elements such as product features, brand name,

labeling, packaging, advertising execution, materials, sales promotion, advertising

themes and advertising media. (1) Customer psyche can dramatically differ across market.

Competitor analysis – It is a program for gathering and analyzing information about

competitors activities and general business trends to further a company’s goal. It will

include products in the market in the specific segment, price structure, market potential

etc. As the pharmaceutical market is growing proper analysis of competitor is essential

to overcome the threats

Value analysis – It determines what a business is, what it produces and whether it will

prosper. Value analysis is done by giving some weightage to the new product with

respect to other products in the same segment. It contains product, pricing, branding,

service, promotion etc

Deciding how to enter the market – Once a company decides to target a particular

country, it has to determine the best mode of entry. Its broad choices are indirect

exporting, direct exporting, licensing, joint ventures and direct investment.

Deciding on the marketing program – Companies must decide how much to adapt their

marketing strategy to local conditions. Standardization of the product, communication,

positioning and distribution channels promises the lowest costs(1)

Company financial status – A company who has decided to go abroad for globalization

should have good financial status. The balance sheet of the company should indicate a

good cash flow to bear the cost necessary for bear the launching cost of the new product

in the global market

Even before launching a product in domestic market some of the above mentioned criteria’s

have to be analyzed.

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Therefore to launch a new product in the global and domestic market, all the above aspects

should be extensively analyzed. The proposed study involves the consideration of all the

relevant aspects for the launch of a new brand of Picalomin (N-nicotinoyl-gamma-aminobutyric

acid) and a combination of Candesartan cilexetil with Hydrochlorothiazide in selected

international and domestic markets. It involves the development of tactics, plans and strategies

which helps to introduce the proposed new brands successfully.

6.2 REVIEW OF LITERATURE

The therapeutic segments identified for the launch of the above mentioned molecules include

depression and hypertension.

DEPRESSION

The disorder depression is a feeling of sadness intense enough to interfere with functioning.

It may follow a recent loss or other sad event but is out of proportion to that event and lasts

beyond an appropriate length of time. (3)

Heredity, side effects of drugs, emotionally distressing events, imbalances in the body,

and other factors can contribute to depression.

Depression can make people sad and sluggish or anxious and fearful.

Doctors base the diagnosis on symptoms.

Antidepressants, psychotherapy, and sometimes electroconvulsive therapy can help.

After anxiety, depression is the most common mental health disorder. About 30% of people who

visit a primary care practitioner have symptoms of depression.

Approximately 18 million American adults or 10% of the population suffer from a depressive

illness in any given year. Depression affects nearly twice as many women as men. (3)

Nearly one in 10 Australians will experience some type of anxiety disorder each year –

around 1 in 12 women and 1 in 8 men. Around one million Australian adults and 100,000 young

people live with depression each year. On average, one in five people will experience

depression in their lifetime - 1 in 4 females and 1 in 6 males. (4)

Depression is one of the many mental health problems is likely to be one biggest health

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concerns for the world, more so in India. There are around 40 million number of patients

suffering from psychiatric ailments(5)

Current therapeutic management: Physical treatment: Antidepressants , Electroconvulsive

Therapy (ECT) Under Investigation, Transcranial Magnetic Stimulation (TMS), Vagus Nerve

Stimulation (VNS)

Psychological interventions and therapies : Cognitive Behavioral Therapy (CBT), Interpersonal

Relationship Therapy (IPT), Rational Emotive Behavior Therapy (REBT)

Complementary and alternative interventions and therapies: Nutritional Supplements, Herbal

Medicines, Natural Therapies, Self management

PICAMILON

Picamilon, Pycamilon, Pikamilon etc (also known as nicotinoyl-GABA) is a dietary

supplement formed by combing niacin with GABA. It was developed in the Soviet Union in

1969 by the All-Union Scientific Research Institute and further studied in both Russia and Japan

as a prodrug of GABA. (6) (7) (8) (9) (10) (11) (12)(13)(14)

Pharmacological actions: Picamilon increases blood supply and functional state of the brain,

increases microcirculation and hemodynamics of the eyes, and enables improved arterial blood

supply to internal organs.  It possesses nootropic, anti-hypoxic and antioxidant properties; is

retained for a long time in body tissues; it is mildly toxic.  In addition, Picamilon renders

tranquilizing (not causing myorelaxation, sleepiness or apathy), and psycho stimulating effects,

restores physical and mental working ability after overwork, and lessens the suppressing

influence of ethanol on the central nervous system.

Indications

Picamilon is used in the capacity of a nootropic agent. Preparation is indicated by conditions

accompanied by anxiety, fear, and elevated irritability. The asthenic states caused by various

neuro-psychological illnesses or connected with increased physical and mental stress,

depressive disorders of the elderly, or senile psychosis.(15)

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Methods of treatment and dosage

For depressive states in the elderly, 40-200mg per day in 2-3 doses, for the duration of 1.5 to 3

months. For restoration of working ability and with increased workload, 60-200mg per day for 1

to 1.5 months; for athletes the same dose for 2 weeks of the training period. (15)

Picamilon is unique in the sense that, while it counteracts stress and anxiety, it doesn't have a

sedative action.  In fact quite the opposite; it can have a mild stimulatory action.  Picamilon may

be the first anti-anxiety drug that doesn't cause drowsiness

Picamilon, a sodium salt of N-nicotinoyl-gamma-aminobutyric acid, was shown to induce a

significant increase of cerebral blood flow in conscious cats. Picamilon was found to inhibit

neurogenic spasms of cerebral vessels that were followed by suppression of tonic activity and

reflectory discharges in sympathetic nerves. Picamilon led to restoration of the initial condition

of cerebral hemodynamics disturbed by a previous administration of serotonin.(8)

The analysis of results of Picamilon clinical investigation in 16 neurologic and psychiatric

clinics on 984 patients with various diseases is presented. Picamilon efficiency and good

tolerance were established. Picamilon was recommended by the Pharmacological Committee of

the Ministry of Health of the USSR for application in medicine for insults therapy, for treatment

of transient disorders and chronic insufficiency of blood circulation and also as a tranquillizer

without the sedative component and myorelaxation; Picamilon is recommended for asthenic

disorders within the limits of different psychical diseases and for treating depressions of old age.

As a therapeutic and prophylactic remedy, Picamilon is recommended for rehabilitation of

capacity for work and for increasing of stability towards physical and psychological burden.

Picamilon is used in narcology in the period of abstinence.(16)

Pycamilon was shown to possess a significant positive effect in some patients under

different tense and extreme mental conditions, neuro-psychic disorder of asthenic,

asthenoneurotic and astheno-depressive character. Pycamilon was found to increase the capacity

of work and the stability to the action of significant physical and psycho emotional tension. This

and the ability of the drug to influence on psychological and vegetative stress sub-syndromes

allow to resume on pycamilon action- and stress protective action.(17)

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HYPERTENSION

Hypertension, also referred to as high blood pressure, is a medical condition in which the

blood pressure is chronically elevated.(6)

Hypertension can be classified either essential (primary) or secondary. Secondary

hypertension indicates that the high blood pressure is a result of (i.e., secondary to) another

condition, such as kidney disease or tumors (pheochromocytoma and paraganglioma). Persistent

hypertension is one of the risk factors for strokes, heart attacks, heart failure and arterial

aneurysm, and is a leading cause of chronic renal failure.

Causes: Primary hypertension

The cause of essential hypertension is unknown but a number of factors are related to its

development. These are as under:

Genetic factors: The evidences in support are the familial aggregation, occurrence of

hypertension in twins, epidemiologic data, experimental animal studies and

identification of hypertension susceptibility gene (angiotensinogen gene)

Racial and environmental factors: A number of environmental factor have been

implicated in the development of hypertension including salt intake, obesity, skilled

occupation, higher living standards and patients in high stress.

Risk factors modifying the course of essential hypertension : These are, age, sex,

atherosclerosis and others (smoking, excess alcohol intake, diabetes mellitus etc).(16)

Secondary hypertension

Renal hypertension: Hypertension produced by renal diseases is called renal

hypertension, which can again be subdivided into 2 groups:

a) Renal vascular hypertension

b) Renal parenchymal hypertension

Endocrine hypertension: A number of hormonal secretions may produce secondary

hypertension. These are due to diseased condition in adrenal gland, parathyroid gland

and oral contraceptives

Coarctation of aorta can cause hypertension

Neurogenic: psychogenic, polyneuritis, increased intracranial pressure etc are

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uncommon causes of secondary hypertension (18)

Often referred to as the ``silent killer,'' hypertension affects 50 million people in the

United States and is responsible for more than 40,000 deaths annually, according to the

American Heart Association. (19)

Pooling of epidemiological studies shows that hypertension is present in 25% urban and

10% rural subjects in India. At an underestimate, there are 31.5 million hypertensives in rural

and 34 million in urban populations.(20)

Hypertension is an important public health issue and contributes to the incidence of stroke

and coronary heart disease. The prevalence of hypertension in Australia was recently shown to

be 29%.(21)

For the management of hypertension following drugs are used…(22)

Beta Blockers – propanolol, atenolol, metoprolol ACE Inhibitors – quinapril, captopril, lisinopril, ramipril, candesartan cilexetil Calcium Antagonists - diltiazem, verapamil, nifedipine Alpha 1 Blockers – prazocine, terazosin Central and Peripheral Sympatholytics – reserpine, methyl dopa, clonidine Direct Vasodilators – hydralazine Diuretics in combination with ACE inhibitors – lisinopril+Hydrochlorothiazide,

Candesartan cilexetil+hydrochlorothiazide

CANDESARTAN CILEXETIL/ HYDROCHLOROTHIAZIDE

The angiotensin II receptor blocker candesartan cilexetil and the diuretic (water tablet)

hydrochlorothiazide is a combination introduced by Astrazeneca. It is used to treat high blood

pressure (hypertension) when one medicine (monotherapy) is not sufficiently effective.The

combination of two medicines that have different ways of working (modes of action) and leads

to a greater lowering of blood pressure in more people than with either medicine used alone.(23)

Candesartan works by blocking the action of a hormone (a natural chemical carried in

the blood) called angiotensin II:

It stops angiotensin II attaching itself (binding) to sites (called receptors) found on cells

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in the body.

In the body Angiotensin II causes blood vessels to become narrowed (constricted) and in

the kidney, it causes less urine to be produced so salt and water are retained in the body.

These actions may be part of the cause of high blood pressure.

If angiotensin II can’t bind to the receptors because of the action of candesartan, the

blood vessels relax and widen and blood pressure decreases.

Hydrochlorothiazide is a diuretic:

o It works mainly by stopping the re-absorption of sodium (salt) and water from

the kidneys back into the blood stream.(23)

This results in increased urine output (diuresis) and increased sodium loss in the urine. These

effects lower the blood pressure

Dose: The daily dose range for tablets of candesartan 16 mg combined with hydrochlorothiazide

12.5 mg to candesartan 32 mg combined with hydrochlorothiazide 25 mg.(24)

Men and women, aged 20–80 years, during treatment with any kind of antihypertensive

monotherapy for at least 4 weeks were randomised to treatment with Candesartan-HCT or Los-

HCT once daily for 12 weeks. Efficacy analysis was performed according to intention to treat.

The reduction in BP was independent of previous antihypertensive agent, gender and age of the

patient. It was concluded conclude that the combination Candes-HCT reduced blood pressure

effectively and was well tolerated. BP was normalised in 61% of these patients who had

insufficient response to previous monotherapy. The reduction in blood pressure and proportion

of patients with normalized BP was greater with Candes-HCT 16/12.5 mg than with Los-HCT

50/12.5 mg.(25)

Monotherapy with an antihypertensive agent is likely to achieve a desirable lowering of blood

pressure in about 50% of patients. The aim of this study was to compare the antihypertensive

effect and tolerability of a once-daily combination of the angiotensin II type 1 (AT1) receptor

blocker candesartan cilexetil, and the diuretic hydrochlorothiazide (HCTZ), with a combination

of the angiotensin-converting enzyme inhibitor, lisinopril and HCTZ in patients with primary

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hypertension. The study included men and women, 20-80 years of age, with sitting diastolic

blood pressure (DBP) of 95-114 mm Hg. After a run-in period of 2 weeks on any

antihypertensive monotherapy, 355 patients were randomized to double-blind treatment with

either a combination of candesartan cilexetil/HCTZ or a combination of lisinopril/HCTZ The

combinations of candesartan cilexetil/HCTZ once daily, and lisinopril/HCTZ, once daily, had

similar antihypertensive efficacy in patients with mild to moderate hypertension during the 26-

week treatment period, candesartan cilexetil/HCTZ was significantly better tolerated than

lisinopril/HCTZ.(26)

The primary objective of the study was to assess the bioequivalence of one candesartan

cilexetil/hydrochlorothiazide (HCT) 32/25 mg tablet and two candesartan cilexetil/HCT 16/12.5

mg tablets after single dose administration. The secondary objective of the study was to assess

the pharmacokinetics of candesartan cilexetil 32 mg and HCT 25 mg after single dose

administration of the fixed combination tablet and after each monocomponent (ie one

candesartan cilexetil tablet 32 mg tablet and two HCT 12.5 mg tablets). According to the group-

sequential design, 53 healthy male and female subjects, aged between18 and 59 years, with

female subjects comprising at least 20% per treatment group, were enrolled in the first step, to

ensure completion by at least 48 subjects. A total of 48 subjects completed the study. Single

dose administration of candesartan cilexetil and hydrochlorothiazide was well tolerated, and no

new safety issues were identified during the study regardless of the administration schedule.

Headache and dizziness were the most frequently observed adverse events (AE). No deaths,

serious adverse events, or adverse events classified as "other significant AEs" occurred during

the study. No subject discontinued study treatments due to an AE. There were no clinically

relevant changes in laboratory safety variables or physical examinations. An expected blood

pressure lowering effect was observed reaching mean minimum SBP and DBP values at around

8 hours after dosing of 32 mg candesartan cilexetil, ie, after one candesartan cilexetil/HCT

32/25 mg tablet, after two candesartan cilexetil/HCT16/12.5 mg tablets or after one candesartan

cilexetil 32mg tablet. This blood pressure lowering effect was less evident after treatment with

two HCT 12.5 mg tablets.(27)

Picamilon belonging to the therapeutic category of antidepressants and Candesartan

cilexetil with hydrochlorothiazide belonging to the therapeutic category antihypertensives will

be introduced in the Indian and global market by formulating an effective launch strategy.

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This project proposes to assist the company to develop a preliminary strategy plan for

introducing the new product into the market. The plan consists of three part, such as

The first part describes the target market’s size, structure and behavior; the planned

product positioning; and the sales, market share and profit goals sought in the first few

years

The second part outlines the planned price, distribution strategy, and marketing budget

for the first year

The third part of the marketing-strategy plan describes the long-run sales and profit

goals and marketing mix strategy over time.(1)

When launching new products in today’s competitive market, it is critical to develop innovative

launch strategies that differentiate a company’s new brand and position it for maximum growth.

Without aggressive tactics, a company risks in missing a window of opportunity for achieving

optimal results from the launch. The development, evaluation and implementation of launch

strategies are essential for a successful product launch.

Thereby a launch strategy for a product includes the development of strategy that is

externally oriented, proactive, timely, implementable and appropriate for a long time horizon.(28)

6.3:OBJECTIVES OF THE STUDY:-

The study covers the following objectives :

1. To carry out epidemiology study of depression and hypertension in USA, Australia and

India

2. Study of the anti-depressant and anti-hypertensive drugs market with special reference to

Picamilon and Candesartan cilexetil with Hyrochlorthiazide

3. To find out the prescription trends for the treatment of Depression and Hypertension in

these mentioned countries.

4. To assess the risk factors in the selected countries before launching the proposed

products.

5. Preparation of the launch strategy for a emerging company in regard to above mentioned

drugs in international and domestic market

7. MATERIALS AND METHODS:

7.1 SOURCE OF DATA:

The source for market research will include:

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Primary source: Primary data will be obtained from the identified respondents by the

administration of questionnaire following informed consent

Inclusion criteria:

a) Doctors who are psychiatrist, neurologist, cardiologist, general physician and

general practitioners practicing in foreign countries and in India.

b) Registered pharmacists who are at retail outlets and hospitals

Exclusion criteria:

a) Doctors who do not belong to the specialties mentioned above and who

practice in Ayurvedic , Homeopathy, Unani etc are not included in the study

b) Pharmacist who are not registered and trainees are not included in the study

Secondary source:

a) Journals

b) Trade and business journals

c) Internationals magazine

d) Textbook of pharmaceutical marketing and international marketing

e) Internet

f) Pharma pulse

g) Pharma biz

7.2 Method of collection of data:

Preliminary communication with doctors and pharmacists through email or personal

interview to get consent to participate in the survey

Sample size:

In USA and Australia

1) Doctors:

15 Psychiatrist

15 Cardiologist

2) Pharmacists:

15 pharmacists

In India

1. Doctors:

a) 25 Psychiatrists

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b) 25 Neurologists

c) 25 Cardiologists

d) 25 General physicians

e) 25 General practitioners

2. Pharmacist:

a) 25 registered pharmacists

Survey area: Australia, USA and India

.

7.3 Does the study require any investigation or interventions to be conducted on

patients or other humans or animals ?

Doctors, Chemists from the respective healthcare fields will be interviewed, hence prior

permission will be sought.

7.4 Has ethical clearance been obtained from your institution?

Applied for ethical clearance.

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8.0 LIST OF REFERENCES :

1. Kotler Philip, Keller Kevin Lane , Koshy Abraham , Jha Mithileswar, Marketing and

management, A South Asian Perspective, twelfth edition, India Dorling Kindersley Pvt.

Ltd,Copyright © 2007

2. Cateora Philip R. and Graham John L. , International Marketing, tenth edition, The

McGraw-Hill Companies, Inc Copyright ©1999

3. All about depression, Fri. November 2008, Available from: URL:

http://www.allaboutdepression.com/

4. Family relation service, Australia; Available from: URL:

http://www.frsa.org.au/site/Depression%20and%20Anxiety.php

5. India Today in, Available: from: URL: http//indiatoday.digitaltoday.in/index.php

(November 6, 2008 Thursday)

6. www.wikipedia.com

7. Kopelevich V. M.; Gunar V. I. (April 1999). "Some approaches to the directed search

for new drugs based on nicotinic acid". Pharmaceutical Chemistry Journal 33 (4): 177-

187

8. Mirzoian RS, Gan'shina TS (1989). "[The new cerebrovascular preparation pikamilon]"

(in Russian). Farmakologiia i toksikologiia 52 (1): 23–6.

9. Matsuyama K, Yamashita C, Noda A, Goto S, Noda H, Ichimaru Y, Gomita Y (October

1984). "Evaluation of isonicotinoyl-gamma-aminobutyric acid (GABA) and nicotinoyl-

GABA as pro-drugs of GABA". Chem. Pharm. Bull. 32 (10): 4089–95.

10. Dorofeev BF, Kholodov LE (1991). "[Pikamilon pharmacokinetics in animals]" (in

Russian). Farmakologiia i toksikologiia 54 (2): 66–9.

11. Shephard RA (June 1987). "Behavioral effects of GABA agonists in relation to anxiety

and benzodiazepine action". Life Sci. 40 (25): 2429–36.

12. Gille A, Bodor ET, Ahmed K, Offermanns S (2008). "Nicotinic acid: pharmacological

effects and mechanisms of action". Annu. Rev. Pharmacol. Toxicol. 48: 79–106..

13. Pukhal'skaia TG, Maĭsov NI, Mirzoian RS (1989). "[The effect of antimigraine

preparations on serotonin transport in the brain synaptosomes of rats]" (in Russian).

Farmakol Toksikol 52 (6): 39–43.

14. Prousky J, Seely D (2005). "The treatment of migraines and tension-type headaches

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with I ntravenous and oral niacin (nicotinic acid): systematic review of the literature".

Nutr J 4: 3

15. Smart Nutrition, 1765 Garnet Ave, San Diego, CA 9210, Available from: URL:

http://www.smart-nutrition.net/picamilon-article2.htm

16. Huaichenko A. P.; Kruglikova-Lvova R. P. , The Pharmacological Committee of the

Ministry of Health of USSR, 25, Kropotkinaky per., Moscow! NPO, "Vitamins," 14 A,

Nauchny proezd, Moscow 117246, USSR

17. Life Extension, Copyright © 1995-2008; CNIMPL, 26, Raspletin St., Moscow 123060,

USSR; Available from: URL: http//www.lef.org/prod_hp/abstracts/picamilon.htm

18. Mohan Harsh , Essential Pathology for Dental Students, second edition, Jaypee Brothers

Medical Publishers (P) Ltd© 2002

19. Hospital Universitario de Caracas Servircio de Anestesiologiia, Atacand HTC Dated

10/01/00, Available from: URL:

http://www.geocities.com/anestesiologiahuc/geobook.html

20. Journal of Human Hypertension (2004) 18, 73–78. doi:10.1038/sj.jhh.1001633,

Received 19 June 2003; Accepted 7 July 2003. Available from: URL:

http//www.nature.com/jhh/journal/v18/n2/abs1001633a.html

21. “Blood pressure change in weight is affected by diet type in men” ,American Journal of

Clinical Nutrition, 2005, © May 2005 ,Vol. 81, No. 5, publication Dec 14, 2004, 983-

989, Available from: URL: http//www.ajcn.org/cgi/content/full/81/5/983?maxtoshow

22. Rang H P , Dale M M ,Ritter J M, Flower R J , Rang and Dale’s Pharmacology, sixth

edition, ,Philadelphia, USA, Churchill Livingstone Elsevier © 2007

23. Patient Health International Atacand® Plus Candesartan Cilexetil/ Hydrochlorthiazide

2003, Available from: Url:www.patienthealthinternational.com/product/5.aspx

24. Drugs.com, Available from: URL: http//www.drugs.com/ppa/candesartan-cilexetil-

hydrochlorthiazide.html

25.  Öhman K.P.; Milon H.  and Valnes K. , Candesartan cilexetil-HCT in primary

hypertension insufficiently controlled on monotherapy—a comparison with losartan-

HCT, American journal of hypertension, Abstract number (A069)

26. McINNES G.T.; ISTAD H.; KEINÄNEN-KIUKAANNIEMI S.; VAN MIERLO

H.F.C.M. Source: Blood Pressure, Volume 9, Supplement 1, 15 May 2000 , pp. 61-61(1)

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27. Clinical Pharmacology Study Report Synopsis, Drug Substance Candesartan cilexetil/

Hydrochlorothiazide, Study Code D2456C00004, Edition Number 01 Date 06 March

2008, United Kingdom, Available from: URL: http//www.astrazenecaclinicaltrials.com

28. Aaker D.A. Strategic Marketing Management, John Wiley and Sons Asia Pvt. Ltd, 2000

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9. Signature of the candidate:

10. Remarks of the Guide:

11. Name and Designation of:

11.1. Institutional Guide:Dr.V.Kusum DeviProfessor,Dept. of pharmaceutical Marketing and ManagementAL-Ameen College of Pharmacy Hosur road, Bangalore-560 027

11.2. Signature:

11.3. Co-GuideMr. ASHOKE BHATTACHARYAVice President ProjectsR. L. Fine. Chem.Bangalore -560064

11.4. Signature:

11.5. Head of the Department:Dr.V.Kusum DeviProfessor,Dept. of pharmaceutical Marketing and ManagementAL-Ameen College of Pharmacy Hosur road, Bangalore-560 027

11.6. Signature

12. 12.1. Remarks of the Principal

12.2. Signature Prof. B. G. SHIVANANDAPrincipalAl Ameen College of PharmacyHosur Road, Bangalore – 560 027.

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