[Last Name] 1

[Hariom Rajput]

Bachelor of Pharmacy 3rd year,From Sam global University Bhopal Madhya Pradesh.

Enrollment no. 20PHAR1PA03033,Date:15/02/2023,Mobile no.9171494082

Guidance: Dr. Rita Mourya Ma'am

Gmail- hariomraj9171494082@gmail.com,hariompharma91@gmail.com

“Current Trends, Challenges and Opportunities In Pharmaceutical Industries and Research”

Current Trends:The coronavirus disease 2019 (COVID-19) caused by severe acute

respiratory syndrome coronavirus has determined 399,600,607 cases and 5,757,562 deaths

worldwide. COVID-19 is a serious threat to human health globally. The World Health

Organization has declared COVID-19 pandemic a major public health emergency.

Vaccination is the most effective and economical intervention for controlling the spread of

epidemics, and consequently saving lives and protecting the health of the population.

Various techniques have been employed in the development of COVID-19 vaccines.

Among these, the COVID-19 messenger RNA vaccine has been drawing increasing

attention owing to its great application prospects and advantages, which include short

development cycle, easy industrialization, simple production process, flexibility to respond

to new variants, and the capacity to induce better immune response. This review

summarizes current knowledge on the structural characteristics, antigen design strategies,

delivery systems, industrialization potential, quality control, latest clinical trials and real-

world data of COVID-19 mRNA vaccines as well as mRNA technology. Current

challenges and future directions in the development of preventive mRNA vaccines for

major infectious diseases are also discussed.

R&D RESEARCH AND DEVELOPMENT………….

 [Last Name] 2

New Drug Application:Once FDA receives an NDA, the review team decides if it is complete.

If it is not complete, the review team can refuse to file the NDA. If it is complete, the review

team has 6 to 10 months to make a decision on whether to approve the drug.

FDA Guidelines : FOOD DRUG ADMINISTRATION.

• Follow GMP.Good manufacturing practice.

• Follow GLP.good laboratory practice.

• Follow 21CFR …….. including all guidance a proper compect manufacturing

pharmaceutical products.

Pre-clinical trials:we are Drug advertising effect are see in animals.

Clinical trials: These are a new Drug administration in human being.

Clinical Information For……

Step 1: Discovery and Development.

Step 2: Preclinical Research.

Step 3: Clinical Research.

Step 4: FDA Drug Review.

Step 5: FDA Post-Market Drug Safety Monitoring.

Research is very important for innovation, creation, discover something new.

Research is we are define by NOVEL WORK.

Research is all time presentative something new …....so we can say this sector is not limited.

Jai Hind Jai Bharat

****************END*****************