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Topicals product development NDA,ANDA

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Guru Balaji .S
Guru Balaji .S

NDA,ANDA

Health & Medicine
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Topical product development NDA- New drug application Safety – Toxicity study Skin irritation Cutaenous toxicity Contact sensitization Contact photodermititis Percutaneous absorption?Teratogen? Efficacy: Two well controlled clinical study Manufacturing controls Bioavailability studies Invitro release studies ANDA- Abbreviated New drug application Safety studies – skin irritation, Cutaenous toxicity Manufacturing controls In-vivo bioequivalence or clinical study In-vitro release study Inactive ingredients qualitatively and quantitatively “same” s.gurubalaji@gmail.com

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Topicals product development NDA,ANDA

  • 1. Topical product development NDA- New drug application Safety – Toxicity study Skin irritation Cutaenous toxicity Contact sensitization Contact photodermititis Percutaneous absorption?Teratogen? Efficacy: Two well controlled clinical study Manufacturing controls Bioavailability studies Invitro release studies ANDA- Abbreviated New drug application Safety studies – skin irritation, Cutaenous toxicity Manufacturing controls In-vivo bioequivalence or clinical study In-vitro release study Inactive ingredients qualitatively and quantitatively “same” s.gurubalaji@gmail.com