Pharma Blog
Treatment Algorithm for Hyponatremia
Today, we want to share an algorithm treatment for hyponatremia, a condition where the sodium level in the blood is abnormally low. Timely and appropriate management of hyponatremia is crucial to ensure the best patient outcomes. Here’s a step-by-step algorithm that can help guide healthcare professionals in their decision-making process: ... Read More
Highlights of Recent FDA Guidance on Nitrosamine Drug Substance
For example, FDA Recommended AI Limits for Certain Hypothetical NDSRIs FDA Recommended AI Limits for Certain NDSRIs Related: APIC Guidance on the Risk Assessment for Presence of N-Nitrosamines in APIs
Stability Requirements for Oral Solid Formulations in ANDA
When submitting an ANDA for a generic drug, one of the critical aspects is ensuring the product’s stability. The drug’s stability is a key factor in maintaining its safety, efficacy, and quality over its intended shelf life. Here are some key considerations: Long-term Stability: The generic drug product should retain ... Read More
Compounding Pharmacy Violations Which Put Patients at Risk
During a recent FDA inspection of a compounding pharmacy, several serious GMP deficiencies were found in the facility intended to produce sterile products. The FDA investigators identified several violations, which put patients at risk. The violations included the preparation, packing, and holding of drug products under unsanitary conditions, resulting in ... Read More
Good Practices for Research and Development (R&D) Facilities | WHO Guideline
With an ever-increasing awareness of the risks in pharmaceutical production and control and the lifecycle approaches being followed, greater emphasis is being placed on ensuring that the research and development of products are appropriately controlled and documented. Consequently, it is necessary that manufacturers of pharmaceutical products are able to submit ... Read More
WHO GMP Guideline for Excipients Used in Pharmaceutical Products
The WHO guideline Good Manufacturing Practices: supplementary guidelines for the manufacture of pharmaceutical excipients, was published in the WHO Technical ReportSeries No 885, 1999. As excipients are sometimes used in large quantities in pharmaceutical dosage forms, and may contain impurities, they can affect the quality of a finished pharmaceutical product. ... Read More
FDA Findings and Remedies on cGMP Violations
The U.S. Food and Drug Administration (FDA) recently inspected a US drug manufacturing facility and identified several significant cGMP violations, resulting in a Warning Letter (#649198). The violations include: Here are five remediation actions that the company should take: Cleaning and Maintenance Procedures: Investigations and Deviations: Production and Process Control ... Read More
Fentanyl Patches | Drug Digest
Fentanyl patches are used to relieve severe pain in people who are expected to need pain medication around the clock for a long time (chronic pain) and who cannot be treated with other medications. Fentanyl is in a class of medications called narcotics. It works by changing the way the ... Read More
Different Types of Clinical Research Studies
Clinical research studies come in many different forms, each with its own purpose and unique approach. Let’s take a look at some of the most common types of studies: Prevention trials are like superheroes, working to prevent the development of a particular condition or disease. Researchers test a variety of ... Read More
Difference Between QbD and DoE
Quality by Design (QbD) vs Design of Experiments (DoE) (concepts comparison) Definition: Focus: Application: Approach: Read also: Resource Person: Atefe Nasrollahi
Piperacillin and Tazobactam for Injection | Drug Digest
Piperacillin and Tazobactam for Injection is indicated for the treatment of patients with systemic and/or local bacterial infections, caused by piperacillin resistant, piperacillin/tazobactam susceptible, β-lactamase producing strains of the designated microorganisms in the specified conditions listed below: To reduce the development of drug resistant bacteria, Piperacillin and Tazobactam for Injection ... Read More