Pharma Blog
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
DOSTINEX (Cabergoline) | Drug Digest
DOSTINEX (cabergoline) works by acting on the pituitary gland which is located at the base of the brain. By stimulating this gland, it prevents the production of the hormone prolactin. DOSTINEX is indicated for: 1. Treatment of hyperprolactinemic disorders: DOSTINEX is indicated for the treatment of hyperprolactinemic disorders, either idiopathic ... Read More
Nicotine Gum | Effectively Relief Your Cravings
Nicotine Gum comes in 2mg or 4mg so you can choose the right strength based on how much you smoke. Nicotine is absorbed quickly through the lining of your mouth helping to effectively relief your cravings. What strength you need to use? How to use the gum? Ask your doctor ... Read More
Audits and Inspections in Pharmaceutical Industries | Similarities and Differences
Audit: ensure quality and compliance with systematic, independent examination and documented process Inspection: determination of conformity to specified requirements “Audit” can be seen as an umbrella term, whereas “inspection” is one concrete type of audit. Similarities 1) Both involve a review of processes, procedures, and records.2) Both aim to determine ... Read More
Computer System Validation in Pharmaceutical Industry
CSV is the process of testing/validating/qualifying regulated computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper-based records. The validation process begins with planning, system requirements definition, testing and verification activities, ... Read More
Common Terms Used in USFDA Inspections
Types of USFDA Inspections The agency also conducts inspections to verify the reliability, integrity and compliance of r&d facilities, testing labs, cmo, clinical and non-clinical research being reviewed in support of pending applications. FDA Forms 482, 483 and 484 Establishment Inspection Report (EIR) A comprehensive report that provides a detailed ... Read More