Pharma Blog
Types of Drug Receptor Binding
Biological receptors are capable of combining with drugs in a number of ways, and the forces that attract the drug to its receptor must be sufficiently strong and long-lasting to permit the initiation of the sequence of events that ends with the biological response. Those forces are chemical bonds, and ... Read More
Prednisolone | Drug Digest
Prednisolone is a synthetic glucocorticoid, which works by mimicking the effects of cortisol, a naturally occurring hormone produced by the adrenal glands. It acts on the glucocorticoid receptor, affecting various cellular processes, including: Reducing inflammation by inhibiting the release of inflammatory mediators such as prostaglandins and leukotrienes. Suppressing the immune ... Read More
VagiSense | A Non-Prescription Vaginal Infection Screening Test
According to a study, about 66% of women who self-diagnosed a vaginal yeast infection were wrong. VagiSense® is a non-prescription home vaginal infection screening test that helps identify if vaginal symptoms are more likely caused by a bacterial or parasitic infection to know what steps to take next. It’s a ... Read More
Verification of OOS Results | EDQM Guidelines
VERIFICATION OF INITIAL OUT-OF-SPECIFICATION RESULTS SCOPE The objective of this Annex is to describe the steps to follow for the management of out-of-specification (OOS) testing results. The failure investigation may also be triggered if validation criteria defined by the method or laboratory are not met, including out-of-trend (OOT) results. To ... Read More
Pulmonary Embolism | A Life-Threatening Condition
As a professional pharmacist, it’s critical to shed light on Pulmonary Embolism (PE), a serious condition that can be life-threatening if not promptly treated. What is Pulmonary Embolism? PE occurs when a blood clot travels to the lungs, blocking one or more pulmonary arteries. This blockage can severely impair lung ... Read More
Difference Among Assay on As is Basis, on Dried Basis and on Anhydrous Basis
A. Assay on an As is basis refers to the measurement of the content of a substance in its original state, without any removal of water or other volatile components. This type of assay is used when the presence of water or other volatile components does not affect the accuracy ... Read More
A Comprehensive Comparison between ANDA (Generics) and Biosimilars
Composition ANDA (Generics): Biosimilars: Approval Process ANDA (Generics): Biosimilars: Manufacturing Challenges ANDA (Generics): Biosimilars: Regulation ANDA (Generics): Biosimilars: Market ANDA (Generics): Biosimilars: Analytical Validation ANDA (Generics): Biosimilars: Process Validation ANDA (Generics): Biosimilars: Supply Chain ANDA (Generics): Biosimilars: Read also:
Basics of Tablet Tooling
Tooling can be defined as tools to craft a particular shape. Tableting tools i.e., Punches and dies are essential tools to shape any granules into a solid dosage form by applying compaction force in a compression machine. Any shape be it round, oblong or bullet shape or any special shape ... Read More
Purpose of Tablet Coating
Tablets are the most commonly used dosage form which are manufactured in Pharmaceutical Industries. Many tablets in pharma are coated and some tablets are uncoated. Tablet coating is the process where we apply a thin coat of film formers & related excipients over the tablet surface. REASONS FOR TABLET COATING ... Read More
Facility Readiness Goal Date Decisions Under GDUFA
The Generic Drug User Fee Amendments (GDUFA) aim to streamline the approval process for generic drugs, ensuring timely access to affordable medications. A crucial aspect of this process is the Facility Readiness Goal Date Decisions, which influence the FDA’s timelines for reviewing and approving generic drug applications. Key Highlights from ... Read More
FDA Non-Clinical Study Requirements for IND
Non-clinical studies are essential for assessing the safety and biological activity of an investigational drug before it is tested in humans. Here are the key aspects and requirements for non-clinical studies in an IND application: Pharmacology and Toxicology Information Non-clinical studies primarily focus on pharmacology and toxicology to evaluate the ... Read More