In part two of these blog posts authored by Dr. David Barnes and Lonnie Barish, we will discuss the various types of topical products (ointments, creams, gels, sprays, and lotions), detailing their.
There has been increased interest in the development of topical drug products as a way to deliver drugs locally, rather than systemically and for diseases that occur in the skin, mucosal surfaces,.
Technology transfer aims to commercialize products successfully at your contract manufacturing organization (CMO) partner site. This means the manufacturing, analytics, packaging, relevant.
A feasibility study is a trial run that tests your manufacturing steps, materials, and equipment to confirm that your process is designed correctly. During a feasibility study, any differences in the.
To submit a filing to the FDA, whether that be an NDA, ANDA, or 505(b)(2), a product owner must provide technical files containing a pharmaceutical product's chemistry, manufacturing, and control.
In the most general terms, an over-the-counter (OTC) product can be described as a medicine available for self-medication that does not require a doctor’s prescription. Self-medication is a common.
Although regulations often vary by region, regulators intend to protect public health. Regulatory authorities are expected to carry out their public health mandates by facilitating the timely.
We are often asked, “Why do we need Pharmaceutical Feasibility Studies?”. In the development of a new drug, it is important to note that a feasibility study is probably the single most important.
Oral solid dose (OSD) delivery remains the most popular route for administering drugs. Market forces are prompting pharmaceutical companies to pursue a broad array of OSD development strategies to.
Synchronizing and controlling API delivery, extrusion-spheronization is a robust technique offers pharmaceutical companies a reliable, efficient way to modify and control the release of many of.
