Inference for Quality-by-Design

	Analytical R&D	Inference for QbD is used in Analytical R&D, whereby methods for characterizing new drug substances and intermediates, as well as methods for monitoring chemical processes used to make new drug substances, are identified and developed. Such analytical methods ensure that samples of new drug substances used for preclinical and clinical evaluation meet requisite quality benchmarks.

	BioProcess R&D	Inference for QbD is used in BioProcess R&D, whereby biologically-synthesized drug substances and drug intermediates are developed. BioProcess R&D also produces drug substance for use in preclinical and clinical evaluation, developing economical, scalable processes for manufacturing the biologically-synthesized drug substance or drug intermediate.

	Chemical Process R&D	Inference for QbD is used in Chemical Process R&D, whereby practical chemical syntheses to drug substances and drug intermediates are developed. Chemical Process R&D also produces drug active for use in preclinical and clinical evaluations: developing practical, efficient, scalable, environmentally responsible and economically viable avenues to drug active for implementation in manufacturing.

	Pharmaceutical R&D	Inference for QbD is used in Pharmaceutical R&D, whereby drug candidate dosage forms (e.g., tablet, capsule) are developed. Extensive and thorough physico-chemical and mechanical characterization of drug active and formulated dosage form is required to produce a drug candidate that is suitably bioavailable and stable for use during clinical evaluation.

	Regulatory Affairs	Inference for QbD is used in Regulatory Affairs, whereby strategies are developed that ensure newly developed drugs will surpass regulatory requirements for world-wide commercialization. In this role, Regulatory Affairs is the primary communication link between the drug-developer company and agencies such as the US Food and Drug Administration (FDA) and its international counterparts.

	Supporting Functions	Inference for QbD leverages and extends the capabilities of two important functions that support QbD: nonclinical statistics and pharmaceutical product R&D IT.

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