Deformulation of Pharmaceutical Webinar

In this webinar we introduce Deformulation of Pharmaceutical RLDs and understanding the Q1/Q2 Sameness Requirements for Complex Generics.

he generic pharmaceutical market value is expected to surpass $500 billion by 2030. Generic name drugs are priced around 80% less than their brand-name counterparts and there is a society wide push for lowering drug costs, meaning the generic pharmaceutical market is only going to become more prevalent. Within this push are regulations presented by the FDA labeled Q1 and Q2. Q1 covers the sameness of ingredients (inactive) and Q2 covers sameness of concentration. EAG has over 10 years’ of experience deformulating more than 220 unique pharmaceutical formulations for our customers.

In this webinar we will cover:

  • Overview of Q1/Q2 Regulations
  • Common characterization techniques
  • The process with EAG
  • Example Case studies:
    • Example Topical
    • Example Solid Oral
    • Example Ophthalmic

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