What is an IND?
An IND is an Investigational New Drug Application that is required by a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to perform human clinical studies for investigational drug or biological product. This is federally mandated, and the requirements are set forth in 21 CFR Part 312. Why are INDs […]
Patient Compliance Through Drug Delivery Systems
Lack of patient compliance in medication is a major cause of poor health outcomes. There are a variety of reasons that contribute to this lack of patient compliance. Forgetfulness, adverse side effects, lack of access to medicine, high cost, inability to swallow large tablets or capsules, fear of needles, and poor taste are all reasons […]
What is CMC?
In the pharmaceutical industry, CMC stands for Chemistry Manufacturing and Controls. Quality and consistency of medicines is the primary responsibility and focus of the CMC function. The FDA regulates all CMC requirements for the pharmaceutical industry, which covers all aspects of drug substance and drug product chemistry, manufacturing, and quality control (QC). CMC consists of […]
Frequently Asked Question: Dissolution testing
Dissolution testing of pharmaceutical drug products is one of the most important tools during drug development and for quality assurance during quality control (QC) release testing. This testing is mandatory for all oral solid dose, oral semi solid dose, and oral suspension products. It is not required for drugs that are already in solution such […]
Why Your Early-Stage Drug Development Needs an R&D-Focused CDMO Partner
Early-stage drug development is best performed at an R&D-focused CDMO. Initial formulation and small batch manufacturing for proof-of-concept clinical trials require speed, agility, and cost-effectiveness as opposed to the scale of a Phase III or routine commercial manufacturing-focused CMO. Preclinical work in early-stage drug development encompasses the following: These activities must generally be completed prior […]
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 […]
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 […]
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 […]