Pharma Blog
Antigens and Immunoglobulins
An antigen is any foreign substance, of whatever origin, that is capable of initiating the production of a specific blood protein called an immunoglobulin (e.g., Ig) that will act against it. The Igs so formed will react specifically with that particular antigen, neutralizing its biological effect. Thus antigens are sometimes ... Read More
Effects of pKa on the Biological Properties of Ionizable Drugs
Acidic drugs (e.g. aspirin) are generally more highly bound to plasma albumin, giving a lower volume of distribution, i.e. they tend to stay in the plasma rather than distribute to the tissues. Basic drugs (including many CNS-acting agents such as phenothiazines) are theoretically more prone to binding to acid glycoprotein, ... Read More
Asthma Problem | Symptoms and Risk Factors
Asthma inflammation is primarily due to eosinophil activity. The incidence of asthma in adults and the elderly is approximately equal. Asthma develops in a person with a genetic predisposition to asthma who is exposed to an environmental trigger. Asthma inflammation is associated with narrowing of the airway lumen and loss ... Read More
Explanation of FDA Designations
Navigating the complex landscape of clinical trials can be overwhelming, especially when it comes to understanding the various designations put forth by the U.S. Food and Drug Administration (FDA). Here’s a breakdown of some crucial designations: Standard Designation: Standard designation is the typical pathway for drug development, involving preclinical studies ... Read More
EU and US GMPs | Understanding the Similarities and Differences
Similarities 1) cover a wide range of products, including RX drugs, OTCs, biologics, & medical devices. Regulations apply to all stages of manufacturing, from raw material sourcing to the final packaging and distribution. 2) require manufacturers to provide adequate training to their employees. 3) prescribe certain standards for facility design ... Read More
Amendments vs Supplements | USFDA
Both amendments and supplements are important tools in the USFDA’s regulatory process with some key differences. Amendment Initiated by the company or requested by the USFDA to make a change to an unapproved application/PAS/tentatively approved application. There are three categories of amendments: major, minor, and unsolicited. Major amendments are changes ... Read More
Pharmacological Treatment Options for Hypertension
First line agents: Second line agents: Combination Therapy Advantages: Treatment of Resistant Hypertension: Strategies to Improve Adherence to Pharmacotherapy Assist your patient by: Assist your patient in getting more involved in their treatment regimen by: Follow-up: Home Blood Pressure Monitoring: Read also:
QUTENZA (Capsaicin) For Neuropathic Pain
QUTENZA is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia and for neuropathic pain associated with diabetic peripheral neuropathy of the feet. Mechanism of action Only physicians or healthcare professionals are to administer and handle QUTENZA Usage − Administer it in a well-ventilated treatment area. ... Read More
MOUNJARO (Tirzepatide) | Drug Digest
MOUNJARO (tirzepatide injection) is indicated for once-weekly administration as an adjunct to diet and exercise to improve glycemic control for the treatment of adult patients with type 2 diabetes mellitus. Limitations of Use MOUNJARO is contraindicated in patients with a personal or family history of MTC and in patients with ... Read More
Framingham Risk Score Calculation
The Framingham Risk Score (FRS) is a widely used tool for estimating an individual’s 10-year risk of developing cardiovascular disease (CVD). It was developed based on data collected from the Framingham Heart Study, a long-term, ongoing cardiovascular study initiated in 1948 in Framingham, Massachusetts, USA. Risk based upon: Recommended to ... Read More
Key Steps in Uncertainty Determination Based on Empirical and Modeling GUM Approaches
Identify the sources of uncertainty: The first step is to identify and understand the different sources of uncertainty in the measurement process. This can include variability in the measurement instrument, environmental conditions, operator skill, and other factors. Quantify the uncertainty from each source: Once the sources of uncertainty are identified, ... Read More