Drug discovery and Development by vinay gupta

July 17, 2013 vinay-pharmacology 1
Clinical Presentation
at
UP RIMS & R, Saifai, Etawah
On
23rd June 2011
Vinay Gupta
(Lecturer)
Department of Pharmacology
UP RIMS & R
Drug Discovery & Development

Drug Discovery & Development Process
Ref: Bennett & Brown: clinical pharmacology
Clinical StudyClinical StudyClinical StudyClinical StudyClinical StudyClinical Study

Clinical Development of Drug
Clinical trials in the different countries are approved & monitored
by different regulatory agencies-
 1) In India- DCGI (Drug Controller General of India)
Under CDSCO (Central Drug Standard Control
Organization).
 2) In UK- MHRA (Medicine & Healthcare Products
Regulatory Agency), advised by CSM (Committee on
Safety of Medicine).
 3) In USA- FDA (Food & Drug Administration) & CDER
(Center for Drug Evaluation & Research).

Techniques of Drug Discovery
Older Approaches-
 Natural Products (Phytochemical &
Pharmacological Evaluation)-
 Traditional Medicines-
 Modification of the Structure of known drugs-
 New uses of drug already in general use-

Natural Product Screening-
PHARMACOLOGICAL
BIOLOGICAL
SCREENING
Extracts
Purify
Rejected
Positive
Negative
Establish Structure
To Serve as
Lead Compound

Pri-clinical Studies
Discovery & Development Cycle
Establishment of
Test in Animals
LEAD COMPOUND DESIRED ACTIVITY
Crude
Extract
Comp.
Of
Known
Structure
Targeted
Disease
of
Interest
In vitro
Activity
In vivo
Activity
Clinical
Activity
Purification
&
Characterisation
Establishment of
Target Organ
Establishment of
Molecular Target

Newer Approaches-
 Molecular Modeling-
 Biotechnology & Recombinant DNA Technology-
 Positron Emission Tomography (PET)-
 Combinatorial Chemistry-
Techniques of Drug Discovery

Combinatorial Chemistry- The objective of combinatorial
chemistry is the generation of huge
numbers of compounds very quickly.
THERAPEUTIC TARGET
LEAD DISCOVERY
LEAD OPTIMIZATION
DEVELOPMENT CANDIDATE
DRUG
Combinatorial
Chemistry
Impacts Here

Approaches to Drug discovery
Target Selection-
 Molecular Targets (genetic information ).
 Selection Of Lead Compound.
 Validation of Lead Compound.

Many targets are most often Proteins, but Nucleic
Acids may also be an attractive target.
TARGET MECHANISM
 Enzyme Inhibitor- reversible or irreversible
 Receptor agonist or antagonist
 Nucleic acid binder, modifier (alkylating agent)
or substrate
 Ion channels blockers or openers
 Transporters uptake inhibitors

Pre-clinical Studies in Animals
At the Pre-clinical stage, the regulatory bodies generally ask about-
Pharmacological
Testing
To determine the Acute Toxicity of the drug in
at least two species of animals.
To develop a Pharmacological profile of Drug.
Toxicological
Testing
To conduct Pharmacokinetic studies from 2
weeks to 3 months.
Pharmacokinetic
Testing
Pharmacological
Testing
To develop a Pharmacological profile of Drug.Pharmacological
Testing
To develop a Pharmacological profile of Drug.
Toxicological
Testing
To conduct Pharmacokinetic studies from 2
weeks to 3 months.
Pharmacokinetic
Testing

Pharmacological Testing-
Animal Model of Human Disease May Occur-
 1) Naturally- eg. squirrel monkeys develop dementia in
old age which is behaviorally & histologically
similar to AD (Alzheimer's Disease) in human with
about same pathophysiology.
 2) By introduction of genetic defect into the germ cells
of an animal strain so that its reproduction produces
offspring with the disease of interest.
 3) Using drugs/ chemicals to alter or produce disease of
Interest in animal model.
Pre-clinical Studies in Animals…

Toxicological Studies-
Toxicity studies are done to calculate-
 1) Maximum Tolerated Dose. (MTD)
 2) Gross Pathology to Indicate Target Disease.
 3) Satisfactory Therapeutic Ratio ( Efficacy & Toxicity).

Toxicity studies Required for Complete Pre-clinical
development-
Acute Toxicity 2 weeks studies in 3-4 species to determine maximum
tolerated dose (MTD).
Sub-Acute Toxicity 6 month studies in 2 species.
Chronic Toxicity  Up to 12 month studies in rodents & non-rodent to
determine if adverse effects occur with repeated daily
dosing.
Oncology studies for at least 18 months in mice & for
24 months in rat.
Reproductive Up to 9 month studies in 2 species to determine effects
of drug on fertility & reproduction & expose any
teratogenic effects.

‘First do no harm
It is good remedy some times to use nothing.’
Hippocrates (460-355 BC)

‘That medicine is a right one and pure one which
cures a disease
–physical, mental, spiritual-
and does not give rise to
adverse reactions and does not create other disease.’
Charak Samhita

‘All things are poisons and there is nothing that is
harmless,
the dose alone
decides that something is not poison.’
Paracelsus(1493-1541)

Pharmacokinetic Testing
 Physio-chemical properties.
 Designing Dosage forms.
Product Stability
 Shelf life.
 Drug Expiry.
Pre-clinical Studies…

Investigational New Drug Application (INDA)
IND application is a result of a successful pre-clinical
development program & with this a researcher advances to the
clinical trials with following results & information-
1) Animal Pharmacological & Toxicological studies with an
assessment that the product is reasonably safe for initial testing
in human beings.
2) Information pertaining to the composition, stability & control
use for manufacturing the drug substances. This information is
assessed to ensure that the manufacturing company can
adequately produce & supply consistent batches of drug.

INDA Cont…
3) Detailed protocols of proposed clinical studies to assess
whether the initial phase trials will expose subject to
unnecessary risks & details of Clinical investigators
(usually Physicians/concerned branch Specialist) who
oversee the administration & monitoring of the subject for
experimental compound.
The IND is not an application for marketing approval but it
is an approval for further proceedings of clinical trials in
human beings.

Phases of Clinical Development
Phase I: Human Pharmacology (20 to 50 subjects)
 Healthy volunteers or volunteer patients according to class
of drug & its safety & initial introduction of experimental
drug to humans.
 Deals with pharmacokinetics (ADME) &
 Pharmacodynamics with tolerability, safety & efficacy
parameters.
Time Period: 1-2 Years

Phase 1 Trial Address:
 How rapidly the drug is absorbed.
 Where is the drug distributed in the body.
 Which organ/system are involved in
metabolism of the drug.
 Drug elimination rate in the body.
Phase 1 Trial Address:
Phase I Trial Address:

Phase II: Therapeutic Exploration (50 to 300 subjects)
 Volunteer patients.
 The study helps to determine common short term side effects &
risks associated with the experimental drug.
 Establishment of Pharmacokinetic & Pharmacodynamics Dose
ranging, in carefully controlled studies for efficacy & safety.
 The study may be conducted with test & placebo drugs as-
• Open non blind trial.
• Single blind trial.
• Double blind trial.

Phase II Trial Address:
 What is the minimum effective dose ?
 What is the max. tolerated effective dose ?
 Is the drug effective in mild, moderate &
severe case of disease/condition.
 Is the drug effective for all expected
indications.

Phase III: Therapeutic Confirmation (250 to 1,000+)
 Phase 3 studies are expanded as controlled & uncontrolled trials.
 The aim of this phase is to verify the drug’s effectiveness & possibility of
any adverse reaction in a large group of patients over a longer period of
exposure, to establish safety & efficacy of experimental drug &
comparison with existing drug.
 In b/w all Phases, the regulatory bodies can impose a clinical hold if the
study is unsafe or if the protocol design is deficient in meeting its stated
objectives.
Once the phase 3 clinical trial has been completed satisfactorily, the
organization can apply for marketing application to the regulatory
authorities to market the drug by filing NDA (takes 12 months for
approval).

The value of toxicity testing is illustrated by experience
with triparanol a cholesterol lowering drug marketed in
the USA in 1959.
Three years later a team from FDA made a surprise visit
that revealed falsification of toxicological data,
demonstrating cataracts in rats & dogs, the drug was
withdrawn but some patients who had been taking it for a
year or more also developed cataract.

Phase III Trial Address:
 Overall Risk-benefit relationship.
 Adverse Reactions in large group of patients
over a longer period of exposure .
 The ideal dosage regimen.
Should the drug is allowed to be marketed.

New Drug Application (NDA)
It is an application submitted to regulatory agency (DCGI) for
permission to market a new drug product.
The sponsor have to submit the pre-clinical & clinical test data,
analysis, drug information & description of manufacturing
procedure.
After a NDA is received, it undergoes a technical screening
generally referred as Completeness review for a period of 12
months.
 After approval, the license is issued to the sponsor for
the exclusive marketing rights for a limited period which
is further renewable with satisfactory drug response.

Phase 4 (Post Marketing Surveillance)
Some times ADR only come to light after drug has been in the market for a while
& has been used by a large population. Post Marketing Surveillance identifies
such problems.
Withdrawal of a drug from the market is not an uncommon occurrences eg.
Drug Name Withdrawn Remarks
Thalidomide 1950-60 Teratogenicity (Phocomelia).
Phenacetin 1983 Risk of cancer & Kidney Problems
Chlormezanone 1996 Toxic epidermal necrolysis
Cisapride 2000 Risk of Cardiac Arrhythmias
Roficoxib 2004 Risk of MI
Tegaserod 2007 Imbalance of cardiovascular ischemic events
Sibutramine 2010 Europe, US & Australia (Cardiovascular Risk)

Surveillance System: Pharmacovigilance
The term Pharmacovigilance refers to the process of identifying
& responding to issues of drug safety through detection in the
community of adverse drug effects.
ADR monitoring in India: Central Drugs Standard Control
Organization( CDSCO) under ministry of health and family
welfare launched the National Pharmacovigilance Programme
(NPP) in Nov.2004.
Under this programme, the whole country is divided into zones
and regions for operational efficiency.
The reports from periphery is sent to higher centre and then to
WHO center (Uppsala Medical Centre, Sweden).

CDSCO (Central Drug Standard Control Organization),
Nirman Bhawan, New Delhi is at the top of the hierarchy
followed by two zonal centers viz.
Seth GS Med. College, Mumbai and
AIIMS, New Delhi.
Five regional pharmacovigilance centers are-
Kolkata (IPGMR-SSKM Hospital)
Mumbai (TN Med.College)
Nagpur (Indira Gandhi Med.College)
New Delhi (Lady Hardinge Med.College)
Pondicherry (JIPMER)
ADR monitoring in India:

A Tale to Remember
The Thalidomide Disaster
Seal Extremities
Phocomelia
CONTERGAN

Research & Development Time Scale
Pre-Clinical
(Synthesis)
IND Clinical
Study
NDA Phase IV
(Launch)
Patent
Expiry
1992 1996 2002 2003 2004
(10-12 year)
2012
Discovery
Research
Clinical Development Regulatory
Review
Development &
Post Marketing
2000-6000 compounds 1 Drug
RATE OF ATTRITION
Cost about 500 million Dollar

Essential Clinical Trial Documentation
1) Protocol- A document that states Objectives, Design,
Methodology & Statistical consideration of study.
2) Informed Consent Document (ICD)- A document for
voluntary written consent of a subject’s willingness to participate
in the particular study.
3) Investigator’s Brochure (IB)- A collection of data including
justification for the proposed study, the nature, scale & duration
of the proposed trial & to evaluate the potential safety.
4) Case/Clinical Record Form (CRF)- Recorded data & other
information on each trial subject on a prescribed format.

5) Source Document (SD)- may include Subject’s file,
recordings from automated instruments, tracings, X ray & other
investigational documents.
6) Regulatory Approval- a document to grant permission to
conduct a trial from Investigator’s site. The approval must be
obtained prior to initiating the clinical trial & the duration of
approval.
7) ERB/IRB/IEC Approval- The approval must be obtained
prior to initiating any clinical trial & the duration of approval.
8) Financial Agreement- Financial aspect of the trial b/w
investigator (institute) & the sponsor.

9) Curriculum Vitae (CV)- A document to provide qualification &
eligibility of investigator(s) prior to initiate the trial.
10) Investigational Product Accountability- A document to
provide complete accountability of investigational product including
receipt, dispensing & storage condition of the test drug etc.
11) Certificates of Analysis (COA)- A document to provide
identity, purity & strength in term of assay of investigational
product.
12) Clinical Study Report (CSR)- A report prepared at the end of
the trial including results & interpretation for submission to
regulatory bodies.

Statistical Approaches In Clinical Trials
Requirement of Statistics-
“Making wise decision in the face of uncertainty.”
 To find the action of a drug – the response produced is due to the drug or
independent of it.
 To compare the safety & efficacy of a particular drug or two different drugs.
 To find out the relative potency of a new drug with respect to the standard
drug.
 To find out an association between two attributes.
 Clinical trial design based on the primary & secondary objectives.

Power and sample size.
Bias & Confounding.
Randomization.
Stratification.
Blinding.
Intent-to-Treat.
Randomized controlled designs-
 Parallel Design
 Multi arm parallel Design
 Factorial Design
 Cross-over Design
 Two stage Design
 Adaptive Design
 Equivalence Design & non inferiority Design

Statistical Errors in Clinical Trials
 Type 1 Error
 Type 2 Error
Statistical Analysis Methods-
1) Parametric Tests
 ANOVA
 t-Test
 One Sample t-Test
 Two Sample t-Test
 Paired t-Test
2) Non Parametric Tests
 Mann-Whitney U Test
 Wilcox on Test
 Krushall-Wallis Test
 Friedman’s Test

Drug Regulatory Act & Schedules
Schedule C - biological & other special products eg. Vaccines, Insulin, Sera
& Antibiotics.
Schedule F - Specification of standard Ophthalmic preparations.
Schedule G - with a label that states “caution” dangerous to use except under
medical supervision.
Schedule H- Prescription Drug.
Schedule J- HIV & Atherosclerosis.
Schedule X- drugs having dependence liability, the supply of these drugs has
to be maintained & recorded in a register.
Schedule Y- Clinical trials in India.
Schedule W- drugs marketed under Generic names.

Ethical Review Board (ERB)
ERB is also known as-
 IRB - Institutional Review Board.
 IEC - Independent Ethics Committee.
 EC - Ethics Committee.
Composition of ERB- (As per ICMR-2000 & Indian GCP-
2001)
 Minimum of 5 Memb. (max. up to 15)
 Includes 1 non-scientific memb.
 Includes 1 memb. Independent from Institute/ trial site.
 1 legal expert.
 Rest may be clinicians & scientists.

CPCSEA (Committee for the Purpose of Control &
Supervision of Experiments on Animals)
Provisions of the prevention of the cruelty to animals Act,1960 &
the rules under the Act of 1998 & 2001.
The concerned research institute are required to get themselves
registered with CPCSEA before commencing the research.
The main activities are-
 Registration of institute for breeding of animals.
 Registration of establishment for experiments on animals.
 Approval of animal house facilities.
 Permission of committee (IAEC) for conducting experiments.
 IAEC Composition- 1 Veterinarian, a non-scientific
socially aware member, a representative of CPCSEA, Scientist
in-charge of animals facility of the institute & other scientist.

Indian Patent Office & Duration
Patent Duration : Term of every patent in India is 20
years from the date of filling of patent application,
irrespective of whether it is filled with provisional or
complete specification.
Administrated by the office of the CGPDTM (Controller
General of Patents, Design & Trade Marks) Mumbai.
Headquarter – Kolkata
 Branch Office – 1) New Delhi
2) Mumbai &
3) Chennai.

DISEASE WISE CLINICAL TRIALS DONE IN INDIA

CDSCOOverall Global Clinical Trials
India 3rd
most preferred destination
Notes: Higher scores indicate higher levels of attractiveness.
The 15 countries analyzed were selected based on size, diversity & geographical distribution.
Czec. Rep.
U.K.
China
Russia
Brazil
Argentina
Poland
Hungary
Germany
Taiwan
Israel
Singapore
Ireland
South Africa
6.10
5.58
5.55
5.26
5.00
5.00
4.90
4.84
4.81
4.69
4.46
4.28
4.27
3.86
4.56
United USA 6.88
Patient pool Cost efficiency Regulatory
conditions
Relevant
expertise
Infrastructure &
environment
Scale : 1-10
INDIA

Study Average US cost (in
millions)
Indian cost
Phase I 40 50% less than the average cost
in US
Phase II 100 60%less than the average cost in
US
Phase III 160 60%less than the average cost in
US
Cost of Clinical trials in USA / India

Growth of Indian Clinical Trial Industry in India
Growth of Indian Clinical Trial Industry
35
120 160
300
1000
0
200
400
600
800
1000
1200
2002 - 03 2005 - 06 2006 - 07 2007 - 08 2009 - 2010
Year
USD(Million)
 As per FICCI - Ernst & Young Survey Report, India can attract between 5 - 10% of the global contract
research outsourced market . (all services including chemistry, toxicology and clinical research) over
next 5 years.

Clinical Trials from India
(www.clinicaltrials.gov)
1
10
100
1000
10000
100000
Phase of trial
No.Trials(Logtransformed)
India 32 165 394 63
USA 6324 11305 5683 2474
All 8540 16878 11662 6142
Phase-1 Phase-2 Phase-3 Phase-4

Country All Studies % Industry
Sponsored
Australia 1572 62.72
Chinese Taipei 903 45.29
Japan 732 67.76
Korea 674 72.26
China 643 53.50
India 582 72.16
Singapore 335 68.36
Thailand 327 69.42
Chinese Hong Kong 250 82.00
Philippines 206 93.20
Malaysia 180 93.33
CLINICAL TRIAL ACTIVITIES IN ASIA
ALL STUDIES
www.clinicaltrials.gov-Snapshot: 7 Feb 2008 Countries with more than 100 studies listed

Sr. No. Company Clinical Trial in India CLINICAL Trial in China
1 Astra Zeneca 10 10
2 BMS 17 6
3 Eli Lilly 17 12
4 GSK 22 14
5 J&J 20 13
6 Merck 8 5
7 Novartis 9 6
8 Pfizer 16 5
9 Roche 5 14
10 Sanofi Aventis 15 13
Total 139 98
GLOBAL CLINICAL TRIALS COMPARISON
INDIA : CHINA

INDIA BUILDING A TRACK RECORD
Clinical Trial Data From India to Achieve an FDA NDA
Drug Company Compound Researched Indication US Launch
Canagene Hepagam Hepatitis B
Jan 06
Eli Lilly Alimta Cancer Feb-04
Eli Lilly Cialis Erectile dysfunction Nov-3
Jannsen Risperidal Psychosis Oct-03
Wyeth Flumist Influenza May-03
Alcon Vigamox Ophthalmic Infections Jan-03
Glaxo Lamictal Epilepsy Jan-03
Novrtis Zelcorm Irritable Bowel Syndrome Jul-02
Pfizer Vfend Fungal Infection May-02
Eli Lilly Xigris Septicemia Nov-01
Santen Quixin Ophthalmic Infections Oct-00

Evolution of Drug Regulation
1) Virus Toxin Act of 1902.
2) Federal Food & Drugs Act of 1906.
3) The Sherley Amendment of 1912.
4) The Food, Drug & Cosmetic Act of 1938.
5) The Federal Insecticide, Fungicide & Rodenticide Act of 1947.
6) The Durham Humphery Amendment of 1951.
7) Insulin & Antibiotic Certification Amendments 1952.
8) Comprehensive Drug Abuse Prevention & Control Act of 1970.
9) Orphan Drug Act of 1983.
10) Drug Price Competition & Patent Term Restoration Act 1984.
11) Generic Drug Act of 1990.
12) FDA Modernizations Act of 1997.
13) Paediatric Exclusively Act of 1998.
14) Prescription Drug User Fee Act of 1994-2003.

THANKS
Dedicated to those poor animals whose
life
were sacrificed for our
future

INDIA BUILDING A TRACK RECORD
Clinical Trial Data From India to Achieve an FDA NDA
Drug Company Compound Researched Indication Launch
Canagene Hepagam Hepatitis B
Jan 06
Eli Lilly Alimta Cancer Feb-04
Eli Lilly Cialis Erectile dysfunction Nov-3
Jannsen Risperidal Psychosis Oct-03
Wyeth Flumist Influenza May-03
Alcon Vigamox Ophthalmic Infections Jan-03
Glaxo Lamictal Epilepsy Jan-03
Novrtis Zelcorm Irritable Bowel Syndrome Jul-02
Pfizer Vfend Fungal Infection May-02
Eli Lilly Xigris Septicemia Nov-01
Santen Quixin Ophthalmic Infections Oct-00

Ethical Review Board (ERB)
ERB is also known as-
 IRB - Institutional Review Board.
 IEC - Independent Ethics Committee.
 EC - Ethics Committee.
Composition of ERB- (As per ICMR-2000 & Indian GCP-
2001)
 Minimum of 5 Memb. (max. up to 15)
 Includes 1 non-scientific memb.
 Includes 1 memb. Independent from Institute/ trial site.
 1 legal expert.
 Rest may be clinicians & scientists.

CPCSEA (Committee for the Purpose of Control &
Supervision of Experiments on Animals)
Provisions of the prevention of the cruelty to animals Act,1960 &
the rules under the Act of 1998 & 2001.
The concerned research institute are required to get themselves
registered with CPCSEA before commencing the research.
The main activities are-
 Registration of institute for breeding of animals.
 Registration of establishment for experiments on animals.
 Approval of animal house facilities.
 Permission of committee (IAEC) for conducting experiments.
 IAEC Composition- 1 Veterinarian, a non-scientific
socially aware member, a representative of CPCSEA, Scientist
in-charge of animals facility of the institute & other scientist.

Indian Patent Office & Duration
Patent Duration : Term of every patent in India is 20
years from the date of filling of patent application,
irrespective of whether it is filled with provisional or
complete specification.
Administrated by the office of the CGPDTM (Controller
General of Patents, Design & Trade Marks) Mumbai.
Headquarter – Kolkata
 Branch Office – 1) New Delhi
2) Mumbai &
3) Chennai.

Drug Regulatory Act & Schedules
Schedule C - biological & other special products eg. Vaccines, Insulin, Sera
& Antibiotics.
Schedule F - Specification of standard Ophthalmic preparations.
Schedule G - with a label that states “caution” dangerous to use except under
medical supervision.
Schedule H- Prescription Drug.
Schedule J- HIV & Atherosclerosis.
Schedule X- drugs having dependence liability, the supply of these drugs has
to be maintained & recorded in a register.
Schedule Y- Clinical trials in India.
Schedule W- drugs marketed under Generic names.

Important Results in Drug Research
Since 1806 & onwards
1806
1875
1884
1888
1899
1903
1909
1921
1922
1928
1928
1935
1944
1945
1952
1956
1960
Morphine
Salicylic acid
Cocaine
Phenacetin
Acetylsalicylic acid
Barbiturates
Arsphenamine
Procaine
Insulin
Estrone
Penicillin
Sulphachrysoidine
Streptomycin
Chloroquine
Chlorpromazine
Tolbutamide
Chlordiazepoxide
Hypnotic
Antiinflammatory
Stimulant, local anesthetic
Analgesic and antipyretic
Analgesic and antipyretic
Sedatives
Antisyphilitic
Local anesthetic
Antidiabetic
Female sex hormone
Antibiotic
Bacteriostatics
Antibiotics
Antimalarials
Neuroleptic agent
Oral antidiabetics
Tranquillizer
1962
1963
1964
1971
1975
1976
1981
1981
1983
1984
1985
1986
1987
1987
1988
1990
1991
1993
Verapamil
Propranolol
Furosemide
L-Dopa
Nifedipine
Cimetidine
Captopril
Ranitidine
Cyclosporin A
Enalapril
Mefloquine
Fluoxetine
Artemisinin
Lovastatin
Omeprazole
Ondansetron
Sumatriptan
Risperidon
Calcium channel blocker
Antihypertensive agent (beta-blocker)
Diuretic agent
Anti-Parkinson agent
Calcium channel blocker
Anti-ulcus agent (H2 blocker)
Antihypertensive (ACE inhibitor)
Anti-ulcus agent (H2 blocker)
Immunosuppressant
Antihypertensive (ACE inhibitor)
Antimalaria agent
Antidepressant (5-HT transporter)
Antimalaria agent
Cholesterol biosynthesis inhibitor
Anti-ulcus agent
Antiemetic agent (5-HT3 blocker)
Anti-migraine agent (5-HT1 blocker)
Antipsychotic agent

1994
1995
1995
1996
1996
1996
1997
1997
1997
1998
1998
1999
1999
1999
2001
2001
Famciclovir
Losartan
Dorzolamide
Meloxicam
Nevirapin
Indinavir, Ritonavir,
Saquinavir
Nelfinavir
Finasteride
Sibutramine
Orlistat
Sildenafil
Celecoxib, Rofecoxib
Amprenavir
Zanamivir, Oseltamivir
Fondaparinux
Imatinib
Anti-herpes (DNA polymerase inhibitor)
Antihypertensive agent (A II antagonist)
Glaucoma (Carbonic anhydrase inhib.)
Anti-arthritis agent (COX 2 inhibitor)
HIV reverse transcriptase inhibitor
HIV protease inhibitors
HIV protease inhibitor
Hair loss
Adipositas (uptake blocker)
Adipositas (lipase inhibitor)
Erectile dysfunction (PDE inhibition)
Anti-arthritis agents (COX-2 inhibitors)
HIV protease inhibitor
Influenza (neuraminidase inhibitors)
Thrombosis (synthetic LMWH)
CML (specific abl-TK inhibitor)

Drug discovery and Development by vinay gupta

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