Can AI/ML Help Solve Underrepresentation In Clinical Trials?

 

To assess medicines for safety and efficacy, it is important that clinical trials are representative of biological sex. Too often, there is an underrepresentation of women in clinical trial subject populations. This leads to erroneous data since women differ in presentation, clinical manifestations, and outcomes in comparison to men.2 For example, many medications metabolize more slowly in women and other medications are more active in men. Clinical manifestations may differ because of the unknown pathophysiology for many disorders, and the drug target identification can differ between the sexes for the same disease. Consequently, since details about clinical trial participants often remains underreported in medical journals, the physician deciding on the optimal treatment for a female patient may not be choosing the most appropriate intervention. Alternatively, the side effects of a medication can be different between men and women.3

 

Where these biases occur, they undermine the potential that AI presents to translate, scale, and accelerate drug development insights. In addition, if the base algorithm or the training data for an ML model contains some form of bias, it is extremely likely that the resulting models will perpetuate that bias when recommending subject data sets and for interpreting trial data sets.

 

 

Sandle, T.(2022) Can AI/ML Help Solve Underrepresentation In Clinical Trials?, Clinical Leader, 26^th April 2022: https://www.clinicalleader.com/doc/can-ai-ml-help-solve-underrepresentation-in-clinical-trials-0001

 

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Sandle, T.(2022) Can AI/ML Help Solve Underrepresentation In Clinical Trials?, Life Science Leader, 1^st July 2022: https://www.lifescienceleader.com/doc/can-ai-ml-help-solve-sex-bias-in-clinical-trials-0001

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

What the Eye Can See: Vision Requirements for Personnel Who Inspect Injectable Pharmaceuticals

 

Regulators require pharmaceutical products that are injected into the human body (which are by inference sterile products) to be free of visible particulates. This is because the presence of visible particulates in injectable products may affect patient safety. There are various controls that need to be built into the manufacturing process to minimize the possibility of particle and particulate formation. These controls will begin with product development and proceed to manufacturing controls. In terms of ‘testing,’ this is based on visual inspection techniques, conducted as part of batch release and for stability samples (and retained samples in the event of a customer complaint). Any identified particulates need to be identified, investigated, and corrected. Following this, a preventative action should be put in place to prevent recurrence.

 

In some cases, automated inspection methods are used (either completely automated or semi-automated involving personnel inspections); in other cases, all inspections are performed by personnel; and sometimes a combination approach is used. The inspection process falls under the general definition of non-destructive testing. While automated inspection machines can be used, these are not always reliable. Additionally, automated technologies need to be validated to show that they meet or surpass human inspection capabilities.

 

The focus in this paper is with personnel. This paper looks at the ‘testing’ element – the visual inspection of products by people and considers the nature of eye tests required to ensure that personnel are able to detect particulates that could be spotted by another person with acceptable vision under ideal inspection conditions.

 

In this article, the focus is with visible particles and particulates, which are any mobile, undissolved matter other than gas bubbles unintentionally present in an injectable medicine.

 

 

Sandle, T. (2022) What the Eye Can See: Vision Requirements for Personnel Who Inspect Injectable Pharmaceuticals, Journal of GxP Compliance, 26 (1): DOI: https://www.ivtnetwork.com/article/what-eye-can-see-vision-requirements-personnel-who-inspect-injectable-pharmaceuticals

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Best Delivery Services For Medical Supplies

 

In today's world, more and more items are being delivered straight to your door. As the pandemic proved, being able to get your medical supplies brought directly to you can make it much easier to get prescription medication and other supplies when you need them the most. But unlike many other items, medical supplies often need to be delivered in a timely and careful manner, making it extremely important to choose the right delivery service. If you are wondering about the best options for medical supply delivery, here are some things to keep in mind.

 

By Lizzie Weakley

 

National and International Carriers

Since there is such a wide abundance of medical supplies that need to be delivered to all parts of the world, you may still want to rely on well-known national and international carriers such as UPS or FedEx for medical supply delivery. While they offer the advantage of being able to deliver virtually anything anywhere, the downside is that service can sometimes be spotty, and there is always the possibility of supplies becoming lost or damaged.

 

Medical Courier Service

As more and more people now opt to have medical supplies delivered to their homes and businesses, you may want to take a closer look at specialized medical courier delivery services as an option. Since these services specialize in delivering important items, they often have a better understanding of various rules and regulations, and are often localized businesses that can provide quick delivery and excellent customer service.

 

Online Services

If you like shopping for other things on Amazon, you may want to consider using them for your medical supplies as well. Along with offering practically anything you would ever need in terms of medical supplies, Amazon usually offers free delivery in many cases and has its own fleet of delivery drivers. As a result, you may order something, then be able to receive it the same day.

 

Store Delivery

Finally, more and more retailers, ranging from well-known big-box pharmacies to local businesses, have started to offer their customers delivery of medical supplies straight from the store to the customer's home. If you regularly do business with a local pharmacy, you may want to inquire about this option. Should they provide this service, you should be able to call the store, tell them what you need, and have it delivered in no time at all.

 

Once you find the best delivery service for your medical supplies, you will not only have what you need within a short period of time, but also tremendous peace of mind. This is important if you yourself are reliant on them, or your business supplies medical goods to those who are. 

 

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)