Question

1. What is generic drug? What is the main difference between generic and patented drug?
2. Explain the five main stages of drug development process!
3. What is clinical trial? Explains steps need to be conducted before applying for NDA!
4. Mention five roles of process engineer in drug development process
5. What is the correlation between time and drug concentration in both bioavailability and bioequivalence?
6. Company A discovers a new API used to cure stomach cancer. This API included in BCS class 4, have angle of repose of 15⁰ and is hydrophobic. Suggest the best routes to produce this new API into an efficacious drug along with your reasoning behind it !
7. QC Supervisor of company B found a problem with their tablet. When tested, the tablet is not dissolved within 1 hour time frame as it supposed to. He suggested adding more disintegrants to coupe with the problem. As process engineer, what do you think is the main problem ? and what is your suggestion to solve this problem ?
8. Plan supervisor of company D find traces of water inside the blister pack for their tablet product. Why is this considered a problem ? and suggest how to solve this problem ?
9. For this final thesis research, student C mixed starch with granulated sugar using V-blend machine. He did not add any solvent into the mixture but at the end of the process, both starch and granulated sugar are separated. Give your deduction of why is this happening ? and suggest how to solve this problem !
10. Provide an explanation the importance of shelf life study ? and why there are two types of shelf life study ?

Answer 1

Answer 4. Role of process engineer in the drug development process

1. They need to setup plans for the process development and other processes that are required for the drug Product manufacturing Process.

2. They need to ensure the alignment with the project through the technical integrator.

3. They will be responsible for the proper assessment of the process and if there any problem detected then they are also responsible for timely informing about the issue and how to to solve it.

4. They are responsible for every documentation that is needed in the process.

5. They are also responsible for making a good and professional relationship with the other manufacturing companies.

6. They are also responsible for reviewing the documents that are prepared by any other external partner for the process.

Answer 3. Clinical trial means the testing of drug is done on the human beings to study the effects of the drug on the human being before it is stand for the review in the NDA because Effect of drug sometimes different on animals and human being. the to sure about the safety of the drug testing on humans is required.

The clinical testing have different steps ;

1. The testing of drugs is always done on the healthy human beings to know the accurate effect of the drug. So, the study of drugs is done on healthy human beings generally it includes 20 to 100 healthy human beings for the testing. The main motive of testing on human beings is to determine the side effects of the drug and it's different doses. It also determines the effectiveness of the drug.

2. When the testing of drugs on the healthy human beings is done then the drugs are given to the patients suffering from the disease and they are very closely monitored to know about the effect of drug on the patient.

3. After the completion of testing on the patients and healthy human beings and 87 results about the effectiveness of the drug and its side effects. Initially the testing is done on maximum 100 people but after stage 1 and 2 in the third stage the testing is done on several thousand people in   as controlled or uncontrolled trial.

4. In the 4th phase, when the drug is approved and even becomes available in the market, the study on the drug is still continued to know about its success rate in the people.

ANSWER 2.

The five different stages of drug development process includes :

Stage 1. Discovery of the drug and its development

Firstly, the most important step in the drug development process is the discovery of the drug. There are many pharmaceutical companies which spend a million dollars in the discovery of the particular drug of the disease. After discovering the drug, we need to develop it in the Proper conditions in the Laboratories.

Stage 2. Preclinical research

After the drug is developed in the Laboratories then it should be testified to know the effect of the drug. The testing of the drug is basically done on the animals to know how much the use of drug is safe.

Stage 3. clinical research

It is one of the most important step in the development of drug. after the approval of drug in the pre clinical research and testing which is done on animals. now the drug is tested on the humans to know its effects on the human beings.

The testing on the human beings is done by the professionals and under a specific criteria which is standardized by drug companies and NDA or FDA.

Stage 4. NDA or FDA review

The new drug application or the food and drug administration regulate the all aspects of drug marketing. After the completion of all three stages, the research documents and conclusions should be given to the FDA for review.

stage 5.   NDA post market safe monitoring

The safety monitoring program checks all the type of problems related to the drug. It monitors the quality of the drug in the market and the problems and complaints associated with the drug. If any complaint related to the drug found then they have power to limit the sale of the drug. Inspections are also done in the manufacturing companies to review the quality of the drug.

Answer 1. Generic drug are the drugs which has the same potency, strength, dose as of the drugs that are sold in the market at the name of brand. Generic word means about drug as generic drug are sold in the market with the name of Chemical present in the drug And does not involve advertisement of any brand.

Difference between the generic drug and the patent drug -

Generic drug Generic drug is sold in the market with the name of chemical present in the drug. It does not involve any kind of advertisement of any brand. They are relative cheaper then the patent drugs and price will be same everywhere. Generic drugs are equally effective As the patent drugs because they contain the same active ingredients that are present in the patent drugs but they can differ in the looks and taste then the patented drugs because patent drugs contain other inactive ingredients like colours and flavours etc.

patent drug Patent drugs are sold in the market under the name of Pharmaceutical brands in which they are made. It involves the advertisement of the brand under which the drug is sold. They have high pricing than the generic drugs and Price can also differ from brand to brand for the same chemical drug. patent drugs contain active ingredients as well as inactive ingredients like colours and flavours but the effectiveness of the drug remains the same.