CONS: • Resources: Formulation development activities require investment in time, equipment, and expertise, which may be a challenge for small pharmaceutical companies or start-ups, where these factors are not available in-house. • Drug Substance supply: Sufficient quantities of drug substance are necessary to perform the required formulation development activities. The associated cost of the drug substance must be factored into programme budgets. • Unexpected issues: Even with well-designed formulation development activities performed early in a programme to mitigate programme risk, still may result in unexpected issues during the later stages of development, which may require additional formulation/process changes which can impact upon programme timelines. Overall, the pros of performing formulation development activities early in a programme may well outweigh the cons. and if done correctly, will optimize the performance of the drug and ultimately save time and money.
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