DRUG DEVELOPMENT AND DISCOVERY PHASES

September 14, 2021

DRUG DEVELOPMENT AND DISCOVERY PHASES

INTRODUCTION :- Development of new drug is very difficult, time consuming and very costly process. New drug takes at least 10 years & 500-1000 million US dollars. During last 50 years, hundreds of new drugs have introduced & old drugs withdrawn from market.

OBJECTIVES:-

• Conform the efficacy & safety profile in large populations during practice.

• Detect the unknown adverse drug reactions.

• Evaluation of over-dosage and concomitant treatments.

• Identifications of new indications.

• Pharmacoeconomics.

PROCEDURE :-

Approaches to drug discovery/intention

1. Explain of natural source : Plant information from people (Ephedra,Tulsi,Neem etc)

2. Random or targeted chemical synthesis : Barbitrate,Chlorpromazine.

3. Rational approaches : Physiological,Pathological,Knowledge.

4. Molecular modelling : Protein chemistry + Computer.

5. Combinatorial chemistry.

6. Biotechnology : rDNA.

STAGES : -

1. CONCEPTUAL

2. DEVELOPMENTAL

1. Synthesis /Isolation of compounds : - (1-2 Years).

2. Pre-clinical studies :- (2-4 Years).

1. Screening.

2. Evaluation.

3. Pharmacokinetic.

4. Short term toxicity studies.

3. Scrutiny and grant of permission for clinical trials : - (3-6 months).

4. Pharmaceutical formulation , Standardization of Chemical / Biological / Immuno - assay of the compound.

5. Clinical studies/ Trials : - (3-10 Years).

1. Phase I

2. Phase II

3. Phase III

4. Long term animal toxicity testing.

6. Review and grant of marketing permission : - (0.5-2 Years)

7. Post – marketing surveillance : - (Phase IV studies)

FDA Approval :-

APPLICATIONS :-

• To demonstrate that a drug is safe and effective for its intended use in the population studied.

• Patent and manufacturing information.

• Drug susceptibility to abuse.

• Reports on the design,compliance,and conclusions of completed clinical trails by the Institutional Review Board.

LIMITATIONS:-

• Unknown biological Mechanisms and Biomarkers of Diseases.

• Translational failure using animal models.

• Lack of clinical phenotyping and patient stratification.

• Inability to rely on published data.

• Inadequate collaboration among academia,industry,and government;

• Pipeline challenges.

CONCLUSIONS :- Discovery and Development of new medicines long,complicated process. Research-based pharmaceutical companies are committed to advancing science and bring new drugs to patients. Increase support from government and organization may help in development of safer and cost effective medicines. For ANDA :- To reduce the price of the drug, reduce time development, Increase the bioavailability drug in comparison to reference list drug.

REFERENCE:-

Pandey, Abhay. (2020) https://www.nebiolab.com/drug-discovery-and-development-process/. (Accessed 01 September 2021)

SANDEEP MEWADA

PATEL COLLEGE OF PHARMACY,BHOPAL

B.PHARMACY

Trainee intern - Business Development at Clinosol Research