NDA vs. ANDA: A Comprehensive Guide to Key Differences, Processes, and Regulatory Requirements
A New Drug Application (NDA) and an Abbreviated New Drug Application (ANDA) are the two main pathways for getting drugs approved in the United States. For pharmaceutical companies, grasping the difference between NDA and ANDA is crucial for making smart product decisions. NDAs are intended for new drugs and require detailed clinical data to prove […]
Stability Chambers: Testing Methods, Essential Equipment, and Applications
Stability chambers are a must-have in pharmaceutical research and development. These chambers simulate precise environmental conditions to test the stability of drugs and other products in different settings. Here’s a closer look at the various testing methods used, the essential equipment involved, and how these chambers help maintain product quality and consistency in the pharmaceutical […]
Top 7 Questions for Small Pharma and Pharmaceutical Startups to Ask When Choosing the Right CDMO Partner
Most pharma companies use contract development and manufacturing organizations (CDMOs) for drug development, to manufacture clinical trial material, or as part of their drug product supply chain during commercial manufacturing. But what do you need to consider when choosing the right CDMO for you? Nuance in the Details Choosing the wrong CDMO can lead to […]
Semi-Solid and Semi-Liquid Dosage Forms
Semi-solid and semi-liquid dosage forms are key pharmaceutical preparations that provide unique benefits for drug delivery. These formulations fall between the extremes of solids and liquids, combining properties of both states. They’re designed for external use, making it easy to deliver active pharmaceutical ingredients (APIs) right where they’re needed—on the skin or mucosal membranes. Types […]
The Critical Role of Formulation Development in Product Success
All medicine administered to patients must first be formulated. It’s not possible to provide pure active pharmaceutical ingredients (API) to patients as treatment. The drug must first be formulated into a stable, manufacturable dosage form which releases the correct dose of active ingredient at a precise site of action to be of efficacy. All while […]
The FDA’s 505(b)(2) Explained
Pharmaceutical innovation can stem from a variety of different facets in the industry. Healthcare providers and practicing physicians think of new concepts through observational data from their daily practice to suggest new, improved treatment solutions using existing approved medicines. From a similar vein, university researchers study the existing molecules of active pharmaceutical ingredients (API) in […]
What is a CDMO and Why Does Your Company Need One?
What is a CDMO? A CDMO, also sometimes referred to as a CMO, is a Contract Development and Manufacturing Organization that offers pharmaceutical drug development and manufacturing services to clients. CDMOs offer a wide range of formulation development and commercial manufacturing capabilities, reflecting the variety of pharmaceutical products available in the market today. Difference Between […]
Permeability Enhancers for Bioavailability Improvement
A large number of promising compounds in the pharmaceutical pipelines fall under BCS classification III and IV that show poor bioavailability due to low permeability across biological membranes. Often the only option for safe and effective delivery for these compounds is through injectable routes. However, it is desirable to develop non-injection formulations due to numerous […]
Muco-Adhesion Testing
Muco-Adhesion and Muco-adhesive Delivery Systems Muco-adhesion refers to the adhesion between two materials, one of which is a mucus layer. Mucoadhesive delivery systems can be administered through a variety of routes including oral, nasal, ocular, rectal, vaginal, sublingual and buccal. Besides ease of application, these systems provide unique benefits such providing direct access to systemic […]
IVRT and IVPT: Pivotal Tools in Topical Product Development
Topical products are liquid or semi-solid dosage forms applied to the skin, encompassing both integumentary and mucosal membranes. They can be developed as liquids, gels, creams, ointments and lotions. Semisolid dosage forms can be viewed as extended-release preparations, with the rate of drug release influenced by the formulation and manufacturing process. Evaluation of Topical products […]