Non-Clinical (animal) IND Enabling Studies: What You Need to Know
In drug development, IND enabling studies serve as a vital link between drug discovery research and the start of human clinical trials. These studies are used to compile evidence which shows a New Chemical Entity (NCE) is safe and effective before it is tested on people. Generally, they are also needed for 505(b)(2) product development, especially when a […]
Key Pharmacokinetic Factors in Semi Solid Topical Medication Development
Topical drug products, which are typically semi solid dosage forms, are designed to deliver active ingredient on the skin or mucous membranes, primarily intended for topical application and to exert local therapeutic effects. Topical drug products are available in the market in the form of creams, gels, ointments, and patches. Recently in the world of […]
Clinical Manufacturing Explained: How CDMOs Support the Development of FDA-Approved Trial Materials
The development of clinical trial material (CTM) is a critical phase in the pharmaceutical industry, especially in preparation for human clinical trials. Whether it’s an active pharmaceutical ingredient (API), placebo, or comparator drug, these materials must meet stringent FDA requirements to ensure patient safety and trial efficacy. Contract Development and Manufacturing Organizations (CDMOs) are key […]
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 […]