How the drugs has been brought into the market, what are the several steps involved in the discovery of drugs.
clinical trials are also involved.
COVID-19 new clinical trials have been incarporated
2. What is
“DRUGS”
• A substance used in the
diagnosis,treatment , or prevention of a
disease or as a component of a medication
recognized or defined by the U.S. Food,
Drugs.and Cosmetic Act.
• A drug is any chemical or biological
substance,synthetic or non-synthetic.
3. History
-Plant or Natural products
Plant and Natural Products were source
for medical substances.
Example: foxglove used to treat congestive
heart failure.
-Accidental Observation
1928: Alexander Fleming observed the
effect of mold.
Mold(Penicillium) produce subsctance like
penicillin.
5. NEED OF DRUGS
A drug is anything that affects the
way an organisms works.
Drugs can be taken to enhance
function , such as a student taking
caffeine to enhance alertness.
Drugs are distinguished from
“Food” and substance that provide
nutritional support.
6. CLASSIFICATION OF DRUGS
• Drugs can be categorized in a number of ways, drug is mainly characterized by its chemical
activity or by the condition it treats.
• In general,drugs are classified as
-Therapeutic Classification
-Pharmacological classification(based in mechanism of action and mode of action)
-Chemical Classification
7. Therapeutic Classification
• This classification is diffed as organized drugs is based on their therapeutic usefulness in treating particular diseases.
Influence blood clotting Anticoagulant
Lower blood cholesterol Antihyperlipidemic
Lower blood pressure Antihypertensive
Restore normal cardiac rhythm Antidysrhythmic
Treat angina Antianginal
Therapeutic Classification
FOCUS:CARDIOVASCULAR FUNCTION
Usefulness Drug Classification
8. Pharmacologic Classification
This classification address to the drug’s mechanism of action.
Lowers plasma volume Diuretic
Blocks heart calcium channel Clacium channel blocker
Blocks harmonal activity Angiotensin-converting
enzyme inhibitor
Dilates peripheral blood vessel Vasodilator
Pharmacological Classification
FOCUSING ON THERAPEUTIC APPLICATION
Mechanism of Action Drug Classification
9. Chemical Classification
• The three basic types of drug name are chemical, generic and trade name.
• A chemical name is assigned using standard nomenclature established by the
IUPAC , a drug has only one chemical name which is helpful in predicting a
substance physical and chemical property.
Example: Chemical name for aspirin is 2-acetoxybenzoic acid.
• The generic name of the drug is assigned by the U.S. Adopted Name Council ,
they are less complicated and easily remembered .FDA and WHO routinely
describe a medication by its generic name.
10. Chemical Classification
• A drug’s trade name is assigned by the company who is manufacturing the drug.
Aspirin Acuprin, Anancin, Aspergum, Bayer,
Ecotrin, Empirin, Maprin, Salatin,
Salacol,Supac,Triaphen-10,Verin,
Vanquish,Zorprin.
Generic Substance Brand Name
11.
12. Drug Discovery
“A process that starts with the identification of disease and include methodology, assay
development, lead identification, formulation and animal pharmacological studies,
pharmacokinetics and sagety studies in animal and clinical studies in the human.” is termed as
DRUG DISCOVERY.
It includes following stages:
Basic Research
Studies
Non-clinical development
Clinical Development
13. DRUG DISCSOVERY
• Usual time duration – 2-5 years
• Usual number of projects : 100
• It consists of following components :
1. Target Selection
2. Lead finding
3. Lead generation
14. 1.Target Selection
• Target selection is a decision to focus on finding an agent with a particular biological
action that us anticipated to have a therapeutic utility.
• Target Identification: to identify molwcular targets that are involved in disease
progression.
• Target Validation: to prove that manipulating the molecular target can provide
therapeutic benefits for patients.
16. (A) Molecular Modelling
• Rational drug designing.
• Aided by three-dimensional computer graphics.
• Allows design of structure based on new & known molecules.
• Highly selective targeted compounds are created by enhancing desired properties
of known molecules.
17. (B)Combinatorial Chemistry
• It is systematic and repetitive covalent connection of set of different building
blocks of varying structures to each other to yield a large array of diverse
molecular entities.
• This process is
1. Faster, more efficient and cheaper.
2. Millions of compounds can be synthesized : Chemical Compound
18. (C)Biotechnology
• Therapeutic agents produced by biotechnology rather than conventional
synthetic chemistry are called Biopharmaceuticals.
• Involve the use of recombinant DNA technology /genetic engineering
1. to clone & express human genes.
2. to produce large amount of hormones like insulin.
19. 2.OLD TECHNOLOGY
• Animal models as human disease.
• Natural Products like plants , animals & micro- Organisms:
1. Random screening approach
2. Ethnobiological approach
• Traditional Medicines.
• Modification of structure of known drugs to develop “Me-too/ derivative
medications/ follow-up drugs” drugs.
20. Pre-clinical Trials
• The preclinical stage of drug development involves extensive testing
in animal models.
• To determine if the drug is safe for human trials and it if it performs as it
should.
• side effects of the drug need to be monitored and addressed.
• If pre-clinical trials succeeds then move up for Clinical trials.
21. Clinical Trials
• Clinical trials are a way to test new methods of diagnosing, treating, or
preventing health conditions. The goal is to determine whether something is
both safe and effective.
• A variety of things are evaluated through clinical trials, including:
• medications
• medication combinations
• new uses for existing medications
• medical devices
22. History of clinical trials
• First controlled clinical trials on 12 sailors with Scurvy by James Lind
• 1747-Lind’s study comparing the use of lime and oranges in the treatment of
scurvy.
• 2 patients each
• Two patients were cured by using lime and oranges.
23. Clinical Development: Phase I
• Approximately 10-40 patients – upto 1 year
• Safety and tolerability - healthy volunteers
• Evidence of activity in some areas.
• Produce a clinical pharmacological package.
24. Clinical Development: Phase II
• Phase II A
- 10-100 patients with target disease
- Normally last 9-12 months
• Phase II B
-100-200 patients
- Dose ranging studies
- set minimum dose
25. Clinical Development: Phase III
• 1000-4000 patients
• To demonstrate safety
• Randomized, well controlled and blinded.
• Patients outcome included in the endpoints.
• Timing 2-4 years.
26. Clinical Development: Phase IV
• Specified by the regulatory agencies – Safety is the usual reason.
• This trials happen after FDA(Food and Drug Administration) approved
medication.
• Normally requires approval.
• 10-1000 patients.
Phase V : new claims, new dosage, market support etc.
28. COVID-19
• COVID-19 (previously called novel coronavirus) is a new strain of a
coronavirus that first emerged in Hubei province in China in late 2019
• Coronaviruses are a large family of viruses and can cause the common cold in
humans
• Rarely, new strains of coronavirus can jump from animals to humans to
cause disease.
other examples: SARS (2003) and MERS (2012)
29. Clinical Trials
Clinical Features:
Incubation period: 1-27 days
Recovery time: 3 weeks to 6 weeks
Frequently ported signs and symptoms of patients include:
• fever (77–98%)
• cough (46%–82%)
• myalgia or fatigue (11–52%)
• shortness of breath (3-31%)
30. Classification
Symptoms were categorized as follows:
• Mild cases: The majority (81%) of these coronavirus disease cases were mild
cases include all patients without pneumonia or cases of mild pneumonia.
• Severe cases: This includes patients who suffered from shortness of breath,
respiratory frequency ≥ 30/minute, blood oxygen saturation ≤93%,
PaO2/FiO2 ratio 50% within 24–48 hours.
• Critical cases: Include patients who suffered respiratory failure, septic shock,
and/or multiple organ dysfunction or failure.
31. Clinical trials of COVID-19
Zydus Cadila has secured regulatory approval from the Drug Controller General of India (DCGI)
to conduct Phase I/II human trials of its Covid-19 vaccine candidate, named ZyCoV-D.
In animal studies, the vaccine was able to induce a ‘strong immune response’ in multiple
species, including mice, rats, guinea pigs and rabbits.
Bharat Biotech received the DCGI approval for its Covid-19 vaccine candidate, Covaxin, to
enter Phase I and II studies, which are started in june.
32. Clinical trials of COVID-19
• Covaxin is an inactivated vaccine developed in partnership with the Indian
Council of Medical Research (ICMR)’s National Institute of Virology.
• ICMR is now working to expedite the trials and contacted 12 institutes to fast
track the studies, with an aim to launch the results by 15 August this year.
