Pharma Digests
Addressing Immunogenicity Concerns and Impurity Profiling for Peptide Drugs
Immunogenicity, or the potential to trigger immune responses, is a critical concern for peptide drugs like Teriparatide. Impurities, aggregates, or contaminants in peptide-based generics could lead to unwanted immune reactions. Thus, the FDA recommends evaluating both the innate and adaptive immune responses when developing a generic peptide. Innate Immune Response: ... Read More
Assessing Immunogenicity Risk of Peptides
Immunogenicity risk assessment is crucial in developing highly purified synthetic peptide drug products, especially when referencing recombinant DNA (rDNA)-origin biologics. The FDA’s Synthetic Peptide Guidance and Product-Specific Guidances (PSGs) provide a structured approach to evaluating these risks and ensuring generic peptide safety and efficacy. Key Takeaways from the Guidance & ... Read More
Critical Processing Parameters in the Fabrication of PLGA Microparticles
Introduction Poly(lactic-co-glycolic) acid (PLGA) microparticles have gained significant attention as controlled drug delivery systems. Despite their potential, the translation of these systems from research to FDA-approved products remains limited. A major challenge lies in understanding the critical processing parameters (CPPs) that influence their fabrication and scale-up. A recent study by ... Read More
General Adverse Events in Clinical Trials
FATIGUE: Persistent tiredness not relieved by rest. FEVER: Elevated body temperature due to infection or inflammation. HEADACHE: Pain or discomfort in the head or upper neck. DIZZINESS: A feeling of lightheadedness or unsteadiness. NAUSEA: Sensation of wanting to vomit. VOMITING: Forceful expulsion of stomach contents. DIARRHEA: Frequent, watery bowel movements. ... Read More
Understanding Patent Length and Generic Competition in Pharmaceuticals
Hello everyone! I’ve been preparing to share more insights on pharmaceutical regulations in the future, and today I’ve learned about patents, FDA approvals, and how generics enter the market. How Patent Protection Works Patent Duration FDA Approval Time What Happens After the Patent Expires? Generic Drug Applications Market Exclusivity for ... Read More
Pharmacokinetics of Naproxen
In linear pharmacokinetics (PK), when we increase the dose (D) of the drug, its level in our body or systemic exposure (AUC) increases proportionally (red curve on left graph). What is our inference? This implies that both oral bioavailability (F) and clearance (CL) are constant such that dose (D) and ... Read More
Classification of Antibiotics
Inhibitors of Cell Wall Synthesis These antibiotics target the bacterial cell wall, leading to lysis and death. Beta-lactams: Interfere with peptidoglycan synthesis by inhibiting penicillin-binding proteins (PBPs).Examples: Glycopeptides: Bind to peptidoglycan precursors, preventing cross-linking.Examples: Vancomycin, Teicoplanin. Others: Bacitracin (used topically). Inhibitors of Protein Synthesis These antibiotics target bacterial ribosomes, disrupting ... Read More
Importance of Drug Optimization
Let’s talk about the importance of “Drug optimization” which is a crucial concept in medicinal chemistry and drug design. It refers to the strategy of replacing one chemical group with another that has similar biological activity but different pharmacokinetic properties. For example, consider two NSAIDs available in the market which ... Read More
Citric Acid Cycle: A Journey Into Cellular Metabolism
The Citric Acid Cycle, also known as the Krebs Cycle or TCA Cycle, is foundational to understanding how our cells produce energy. This intricate pathway converts nutrients into usable energy, driving every cellular function. Let’s delve into the details of this essential cycle and its broader implications. The Central Role ... Read More
ESC Key Notes on Obesity and Cardiovascular Disease
European Society of Cardiology (ESC) Clinical Consensus Statement on Obesity and Cardiovascular Disease Read also: Read also: Dr. Suzan Gharaibeh
Mastering the Art of Peak Integration in HPLC
Peak integration in High-Performance Liquid Chromatography (HPLC) is more than just a routine step—it’s the bridge between your experiment and the data-driven decisions that follow. Every peak tells a story, and accurate integration ensures you’re interpreting it correctly. Why is Peak Integration Crucial?The area under the curve (AUC) of a ... Read More