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Challenges of Analytical Method Transfer in the Pharmaceutical Industry

Introduction

Bioavailability is the rate and extent to which the active ingredient is absorbed from the drug product and becomes available at the site of action. It is a measure of how much, and how fast, a drug reaches its target in the body. The bioavailability of a drug can be affected by formulation, route of administration, patient characteristics (e.g., age and body mass), disease state, concomitant medications and food.

What is AMT in Pharma?

AMT is the process of transferring analysis methods from one laboratory to another. In the pharmaceutical industry, Analytical method transfer in pharma is a critical step in the development of a drug product and requires a lot of time and effort. This complex process requires expertise in both analytical chemistry, as well as regulatory affairs.

Accuracy, Precision and Specificity

Accuracy and Precision

Accuracy is the closeness of agreement between a measurement and the true value of that quantity. For example, if you take three measurements using an instrument that is known to be accurate, it should not read different values for a single sample; this would indicate poor accuracy.

Precision is the closeness of agreement between repeated measurements of the same quantity by one method. For example, if you measure 100 different samples with one method at regular intervals (e.g., once every month), then you will usually see some variation in your results due to random error or “noise.” However, if your results are very similar each time you repeat them (i.e., there is little variability), then this means that your method has high precision (and low noise).

Method Development

Method development is the process of developing a method to assess the quality and purity of drug products. The method is developed using procedures that ensure robustness and validation, so that it is suitable for use in routine quality control.

In analytical chemistry, rigorous development of methods for analysis are required to ensure that analytical data are repeatable, reproducible and accurate. In addition, methods should be validated against reference standards that have been independently certified by an external body.

Drift

Drift is a change in the performance of a method over time. It can be caused by a change in the instrument or by a change in the method. For example, if your laboratory uses an HPLC with UV detection and changes to another instrument with different absorbance characteristics for the same compound, this would be considered drift.

Lack of trained staff

One of the most common challenges facing a laboratory is a lack of trained staff. The best analytical chemists are in high demand, and invariably they are pulled away to fill other roles in the company. This can be due to downsizing, reorganization, or even just because they were hired as an analyst but their skills were needed elsewhere. Other times it is simply because there aren’t enough qualified people to go around.

While this may seem like an easy fix by just hiring more analysts, it’s not quite as simple as that. Not only do you need to find someone with the right qualifications who can hit the ground running, but they also need to be able to work well within your own team; this means getting along with colleagues and being able to communicate effectively via email or verbally during meetings about results obtained from testing samples taken from production lines or laboratory experiments conducted at other facilities around town (if those facilities exist).

Dry Labs

The analytical method transfer process at a pharmaceutical company can pose a number of challenges, particularly when it comes to the dry lab. The importance of this part of the analytical method transfer process cannot be understated. A dry lab is where all raw materials and reagents are stored before they are used in an experiment or analysis. This is also where samples will be prepared for testing procedures.

The ideal dry lab should be kept clean, well lit, temperature-controlled, and well ventilated with ample storage space for all chemicals and equipment required to complete experiments in time frames that meet customer expectations. In addition to these basic requirements, there are other elements that must be considered when setting up your analytical method transfer process including:

Bioavailability is the rate and extent to which the active ingredient is absorbed from the drug product and becomes available at the site of action.

What is bioavailability– It is the rate and extent to which the active ingredient is absorbed from the drug product and becomes available at the site of action. The biological activity of a drug substance is dependent on its bioavailability. If a dose of the orally administered drug is not absorbed, it cannot exert its effect on the target organs (e.g., brain). Drug molecules may be excreted unchanged or metabolized prior to reaching their site of action in which case there will be no therapeutic benefit.

Conclusion

It is important that adequate testing be performed to ensure the validity of analytical methods as well as their transfer from one laboratory to another. It is also very important for pharmaceutical companies to find ways of reducing the cost and time involved in phase I and II clinical trials by identifying and selecting suitable dosage forms. The development of modified-release drugs has driven many pharmaceutical companies toward developing bioequivalence studies, which are different from the usual methods used for ordinary drugs due to their complex nature.

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