Drug product development process
Drug product predevelopment activities deal with the creation of baseline data necessary for the formulation of safe, effective, efficacious and stable drug products. Adequate and timely predevelopment activities ensure a drug product that meets safety, stability, quality, identity, purity and potency (SSQUIPP) requirements and is fit for its intended purpose.
Predevelopment tasks involve all the activities aimed at establishing API/Excipient physicochemical properties: pre-formulation and feasibility formulation to aid in the selection of desirable dosage form [6.1] ; feasibility process development and scale-up to aid in the selection of desirable processing equipment and train; a sterilization study aimed at determining the most suitable means of achieving drug product sterility (for sterile products) [6.2] and a feasibility of primary packaging study [6.3], aiding in the selection of primary and secondary packaging equipment and train. Predevelopment activities also support determining overall process configurations with quantified critical process and quality parameters for eventual clinical and commercial manufacturing processes.
In the context of this discussion, the term pre-formulation encompasses the activities associated with the characterization of the physical and chemical properties of a drug substance — including understanding the drug’s response to potential manufacturing, processing and/or packaging conditions — and stressors used to decide a product’s formulation.
Pre-formulation activities (both discovery and development) are focused on assessment of biopharmaceutical properties of early drug development candidates (EDCs); and their subsequent optimization through determination and/or definition of drug substance physicochemical properties to support the formulation of stable, effective and safe dosage forms.
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3. Companies take credit for things they do not do.
While in some cases, a company may do all of the important
stages of research and development for a drug, including both
clinical and pre-clinical investments, but in other cases
governments or private donors fund important parts of
research. Studies have shown that the government role is
particularly true for innovative drugs for severe illnesses,
and less significant for so called "me too" drugs, or for
drugs such less important public health problems, as hair
When the government funds the discovery of a drug, such as in
the case of AIDS drugs like AZT, ddI, ddC, d4T, Ziagen and
Norvir, the taxpayers have paid for the most expensive part of
the R&D process
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