The patient population of a drug in clinical development typically looks much different from the patient population of a drug once it's approved and on the market. Clinical trials for drugs and biologics being tested for approval are appropriately done under controlled settings, typically in academic environments or clinical research sites. This means that the patient population is often not representative of who will be prescribed the medication once it's approved and reaches the market. Only after a drug is approved will it reach patients who may be on multiple concomitant medications and who are in special demographic groups, such as the elderly or women of reproductive potential.
As Gretchen Dieck of UBC recently discussed in a PharmaPhorum article manufacturers can – and should – implement strategies to ensure patient safety in the post-approval period well before a drug reaches the larger patient population.
Safety regulations require that a drug’s benefits outweigh its risks. Planning risk management strategies early in a drug’s development process should be focused on those important risks, both identified and potential, that may tip the benefit-risk balance of a drug.
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