Take Hone Quiz

Journal Critique
Pharmaceutical Analysis 2

Take Home Quiz Journal Critique

Direction: After reading the article, make your own critique of it. This is individual work and will be
considered as a quiz. Follow the ‘Activity Template’ and ‘Sample Critique’
1. Give a brief overview, its purpose, and focus.
2. In IMRAD format, provide the following: (Note: per part of IMRAD)

A. Brief Overview
B. Key points
C. Self-reflection
3. Give a brief conclusion after your critique.

Chosen Article: Quality testing of Difficult to make Prescription Pharmaceutical Products

Marketed in the US

Answers:
1.

The US Pharmaceutical supply has significantly grown due to globalization, but these
result to the uncertainty of the quality of the product and leads to Health Care Practitioners
being skeptical and doubting the quality of the pharmaceutical product thus leading to a
misunderstanding of the patients or consumer. Researchers noted that the survey of the HCPs
displayed biases involving drug quality even if they have little to no evidence regarding the
matter as they were not sure if those legally marketed drugs that is manufactured outside the
US had complied to strict manufacturing guidelines and process. In the journal “Quality
testing of difficult-to-make Prescription Pharmaceutical Products Marketed in the US,” Dr.
Adam Fisher and Alex Veihmann (2020) examine and focuses on the quality of the
immediate release drug products, as this is considered as the difficult to make solid dosage
form, to test its quality and to provide information to HCPs to bolster their confidence
reagarding the pharmaceutical’s quality.
2.

Introduction
Brief overview
Dr. Adam Fisher and Alex Veihmann highlighted that as the supply chain of pharmaceutical
product in the US rapidly grows the higher the concern regarding the quality of the product is subjected,
and it leads to the HCPs (the one that is supposed to be responsible in assuring the patients or consumer
that the pharmaceutical products are of high quality) to lose their confidence regarding the matter as they
are also unsure about the quality of the product being marketed in the US.
Key points:
The introduction indicates that it uses data from a recent survey of HCPs carried out by the FDA
and WebMD which displayed biases in drug quality as the basis in conducting this research. It also
provides and explained the importance of the HCPs’ confidence and belief regarding the quality of the
drug product affects the patient or the consumers perception regarding the matter thus affecting their
clinical compliance and concordance, allowing the patient to get what they want and just follow the
patients request of their chosen branded drugs.

Self-reflection:
This journal has clearly indicated the need or their purpose in conducting this research and gives a
strong background of the study as they used the data from the survey conducted by the FDA. It shows
their target problem and why this research is important.

Methods
Brief overview
Dr. Adam Fisher and Alex Veihmann (2020) used 322 samples in which 252 of it are immediate
release product. And as much as possible collecting samples from at least 3 lots for each product. It
contains the sampling strategy they used and uses methods that analyses the overall performance of the
product such as its hardness, dissolution, dosage unit uniformity, and weight.
Key points
They collect most of the sample from at least 3 lots for each product which increases the results
accuracy and consistency.
Self-reflection
This shows a very detailed information regarding how they conducted and accomplished the
research. They also used a great sampling strategy in which they collect a enough sample from the same
lot to produce accurate results
 Results
Brief overview
It provides the findings regarding the testing of the immediate release drug products in
the US. The result for the dosage unit uniformity shows that all of 277 active ingredient sample
out of 252 drug products have easily met the standards of the USP of about 75% to 125%. This
also shows the Ppks for the dissolution vs dosage uniformity.

Key points
Samples with different dissolution rate met the USP criteria. The result also shows the
difference of Ppks for unit dosage uniformity depending on the region and the manufacturer for
manufacturer the Ppk is above 1.63 exceeding 4 sigma and based on the region the Ppk is above
1.73 exceeding 5-sigma capability.

Self-reflection
The result part of the journal shows a and explain the result in a detailed manner without
leaving any important parts and aspect. It provides an in-depth evaluation of the overall quality
of the pharmaceutical product

3.
Overall, this journal shows and provides accurate and detailed information regarding the
topic and has achieved their goal in providing enough evidence to support the claim regarding
the quality of the difficult to make prescription pharmaceuticals products in the US. They used
sampling method and analysis testing that is perfectly aligned with their study which makes their
research more reliable and accurate thus allowing the future researchers to use this data to further
improve the quality testing of pharmaceuticals .

Reference:
Fisher, A. C. Viehmann, A., Ashtiani,M., Friedman, R. L., Buhse, L. F, Kopcha, M., &
Woodeck,]. (2020) Quality testing of Difficult-to-Make prescription pharmaceutical products
marketed in the US.JAMA Network Open, 3(,e2013920.
https://doi.org/10.1001/jamanetworkopen.2020.13920
Submitted by:
Vicencio, Ciara Gayle C.
October 20,2023