The process of drug discovery and development is a multifaceted journey, marked by innovation, scientific rigor, and regulatory scrutiny. This article provides a comprehensive overview of the intricate stages involved in bringing a new therapeutic entity from conception to market. Beginning with target identification and validation, the review navigates through lead discovery, optimization, and preclinical studies, emphasizing the pivotal role of molecular biology, high-throughput screening, and computational methods in shaping the drug development landscape. The integration of pharmacokinetics, pharmacodynamics, and toxicology assessments during preclinical phases ensures a robust foundation for advancing candidates into clinical trials. The complexities of Phase I-III clinical trials, including patient recruitment, safety monitoring, and efficacy evaluation, are dissected to underscore the meticulous processes that define the clinical development stage. Regulatory interactions, submission of New Drug Applications (NDAs), and post-marketing surveillance constitute the final regulatory phases, ensuring both efficacy and safety in real-world settings. The article also explores contemporary trends, such as precision medicine and the incorporation of artificial intelligence, that are reshaping traditional drug development paradigms. Challenges, including high attrition rates and escalating costs, are addressed alongside innovative strategies aimed at mitigating these hurdles. As the pharmaceutical landscape evolves, a nuanced understanding of the drug discovery and development process is imperative for fostering innovation and delivering transformative therapies to patients.

1. WELCOME
DRUG DISCOVERY AND DEVELOPMENT
Student’s Name Here :-RIMA
DUTTA
Student’s Qualification Here :-
PHARM D (4TH YEAR)
Student ID Here :-
CSRPL_STD_IND_HYD_ONL/CL
S_204/102023
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2. INDEX
.DEFINITION
.STAGES
.PURPOSE
.NEW DRUG DEFINITION (CDSCO)
.METHODS INVOLVED IN DRUG DISCOVERY
.STAGES OF NEW DRUG SYNTHESIS
.TARGET IDENTIFICATION
.TECHNIQUES FOR TARGET SELECTION
.GENOMICS
.LEAD IDENTIFICATION
.ECONOMY OF DRUG DISCOVERY
.CONCLUSION
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3. DEFINITION :-
The process of bringing a new drug or device to a market which
includes chemistry,pharmacology and various concept of clinical
trials. The first pharmaceutical medicine was invented in the year
1804. This was done by a German scientist “FRIEDRICH
SERTURNER”. He extracted the active compound from “OPIUM”
and named it as “MORPHINE”.
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4. STAGES OF DRUG DISCOVERY:-
1. TARGET IDENTIFICATION
2. LEAD DISCOVERY
3. LEAD OPTIMISATION
4. PRE-CLINICAL TESTING
5. CLINICAL TRIALS
6. REGULATORY APPROVAL
7. POST MARKET SURVILLEANCE
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5. PURPOSE :-
➢ IDENTIFYING NEW DRUGS AND DEVELOPING MEDICATIONS.
➢ TO UNDERSTAND UNDERLYING CAUSES OF DISEASE AND
IDENTIFY POTENTIAL DRUG TARGET.
➢ TO FIND NEW TREATMENTS TO IMPROVE PATIENT OUTCOMES
AND ADRESS UNMET MEDICAL .
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6. TARGET IDENTIFICATION
• Target Identification Is Possible Through Pharmacophore models. It Helps in The
Study Of Mechanism Of Selected Drugs. Pharmacophore Models Is Generated By
Predicting the Active Site On Target Protein Involved In Diseases
• De Novo Ligand Designing Of A Compound Or Ligand Having Desired
Pharmacophore Models .
• A Computer Program “Newlead” can able To Develop Desired Ligand Molecule By
Analyzing The Pharmacophore Feature And Connecting The Missing Link.
• The First Step Of Drug Discovery Is TARGET IDENTIFICATION.
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7. TECHNIQUES OF TARGET
IDENTIFICATION:-
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1.DIRECT BIOCHEMICAL METHODS
2. GENETIC INTERACTION
3.COMPUTATIONAL INFERENCE
The Main Target For Drug Actions Are Receptor, ion Channel, enzymes, carrier Molecules.

8. GENOMICS :-
• It Helps To Provide Better Diagnostic Or Disease Predictive Tools For Targeted
Treatment Of Disease.
• It Is Used To Select Out Adverse Drug Effect Before Drug Enter The Clinic. Genomic
Medicine Hold Greatly Into Disease.Genomics Helps To Take A New Chemical Lead
Through Stages To Test A Chemical Lead Through Stages.
• Functional Genomic Is Used To Guide Drug Discovery For Cancer Studies.
• Genetic Driven Drug Discovery Include Enzyme Replacement Therapies For
Lysosomal Storage Diseases.
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9. LEAD IDENTIFICATION:-
It Is A Crucial Step In Drug Discovery Program,Chemical Compounds Could Be The Best
Source Or Starting Point To Obtain Potential Leads With Biological Activity.
The Major Soluble Lead Compounds are :
A)Lead Acetate
B)Lead Chloride
C)Lead Nitrate
Lead Identification Is A Process Or Finding Compound Who Have The Capability Or
Potential To Become Effective Medicines.
The Main Goal Of Lead Identification Is To Find Lead With Great Potency,safety And
Selectivity To Advance By Drug Discovery Pipeline.
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10. ECONOMY OF DRUG DISCOVERY
AND DEVELOPMENT:-
❑ The Significant Investments In Research,clinical Trials, manufactory And Regulatory Process.
Successful Drug Development lead To Substantial returns Of Investment As New Medicine
Can Generate Revenue Through Sales And Licensing Agreement.
❑ The Economic Impact Of Pharmaceutical Industry Is significant,contributing To Job Creation
And Advancement In Healthcare.
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11. CONCLUSION:-
• Drug Discovery And Development is a Complex And Intensive
Process Involves Identifying Drug targets, designing, and
Testing Compounds, conducting Clinical Trials, obtaining
Regulatory Affairs.
• It Can Be Lengthy And Costly Process, successful Drug
Development has the Potential To Greatly Impact Patient Care
And Improve Health Outcomes.
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12. Thank You!
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