Pharma Blog

Common Deficiencies in ANDA Submissions for Peptide Drugs
The FDA highlights several common deficiencies observed in the review of peptide-based generic drugs, including Teriparatide: Impurity Profiles Not Up to Date: Manufacturers often submit impurity profiles based on products aged at release. The FDA recommends that profiles also include data from samples aged at the end of the proposed ... Read More

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

Drug-Device Combination Products | Innovations and Compliance
In the ever-evolving landscape of medical technologies, drug-device combination products represent a cutting-edge integration of drugs, medical devices, and biologics. These products offer innovative solutions for disease management, but they also demand a robust understanding of regulatory frameworks and compliance to ensure safety, efficacy, and quality. What Are Combination Products? ... 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

QMS in Pharmaceutical Industry
A Quality Management System (QMS) is a formalized framework that outlines the structure, responsibilities, and processes for achieving quality objectives in an organization. The QMS ensures that products or services meet customer and regulatory requirements. Content of a QMS: A typical QMS consists of the following elements: Quality Policy: A ... Read More

Navigating Bioequivalence Study Guidelines Across Global Regulatory Bodies
When conducting bioequivalence (BE) or bioavailability (BA) studies for regulatory approval, guidelines from different regulatory bodies must be adhered to. Here’s a summary of the key considerations and variations across major regulatory agencies Regulatory Guidelines Comparison USFDA Special Cases: Study Design: EMA Acceptance Range: Study Design: WHO Study Design: MHRA ... 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