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Drug approval

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Proposed multidimensional pain outcome methodology to demonstrate analgesic drug efficacy and facilitate future drug approval for piglet castration 100%
Angela Baysinger; Sherrie R. Webb; Jennifer Brown; Johann F. Coetzee; Sara Crawford; Ashley DeDecker; Locke A. Karriker; Monique Pairis-Garcia; Mhairi A. Sutherland; Abbie V. Viscardi · file · #16

…This methodology will Drug Administration (FDA) has oversight of approval and safety use multiple outcome variables to, in summation, demonstrate of all products used in animals, including those animals used for analgesic…

Proposed multidimensional pain outcome methodology to demonstrate analgesic drug efficacy and facilitate future drug approval for piglet castration 100%
Angela Baysinger; Sherrie R. Webb; Jennifer Brown; Johann F. Coetzee; Sara Crawford; Ashley DeDecker; Locke A. Karriker; Monique Pairis-Garcia; Mhairi A. Sutherland; Abbie V. Viscardi · file · #83

…This methodology will Drug Administration (FDA) has oversight of approval and safety use multiple outcome variables to, in summation, demonstrate of all products used in animals, including those animals used for analgesic…

Efficacy of Intra-Operative Topical Wound Anaesthesia to Mitigate Piglet Castration Pain—A Large, Multi-Centred Field Trial 5%
Meredith Sheil; Giulia Maria De Benedictis; Annalisa Scollo; Suzanne Metcalfe; Giles Innocent; Adam Polkinghorne; Flaviana Gottardo · file · #25

…Proof of anaesthetic efficacy is challenging in neonatal piglets, particularly in the “field” or “on-farm” setting as per the VICH GL9 standard [53] required for veterinary drug regulatory approvals. There is…

Efficacy of Intra-Operative Topical Wound Anaesthesia to Mitigate Piglet Castration Pain—A Large, Multi-Centred Field Trial 5%
Meredith Sheil; Giulia Maria De Benedictis; Annalisa Scollo; Suzanne Metcalfe; Giles Innocent; Adam Polkinghorne; Flaviana Gottardo · file · #63

…Proof of anaesthetic efficacy is challenging in neonatal piglets, particularly in the “field” or “on-farm” setting as per the VICH GL9 standard [53] required for veterinary drug regulatory approvals. There is…

Behavior of Piglets in an Observation Arena before and after Surgical Castration with Local Anesthesia 3%
Regina Miller; Andrea Grott; Dorian Patzkéwitsch; Dorothea Döring; Nora Abendschön; Pauline Deffner; Judith Reiser; Mathias Ritzmann; Anna M. Saller; Paul Schmidt; Steffanie Senf; Julia Werner; Christine Baumgartner; Susanne Zöls; Michael Erhard; Shana Bergmann · file · #14

…Proposed multidimensional pain outcome methodology to demonstrate analgesic drug efficacy and facilitate future drug approval for piglet castration. Anim. Health Res. Rev. 2021, 22, 163–176. [CrossRef] [PubMed] Disclaimer/Publisher’s Note…

Behavior of Piglets in an Observation Arena before and after Surgical Castration with Local Anesthesia 3%
Regina Miller; Andrea Grott; Dorian Patzkéwitsch; Dorothea Döring; Nora Abendschön; Pauline Deffner; Judith Reiser; Mathias Ritzmann; Anna M. Saller; Paul Schmidt; Steffanie Senf; Julia Werner; Christine Baumgartner; Susanne Zöls; Michael Erhard; Shana Bergmann · file · #81

…Proposed multidimensional pain outcome methodology to demonstrate analgesic drug efficacy and facilitate future drug approval for piglet castration. Anim. Health Res. Rev. 2021, 22, 163–176. [CrossRef] [PubMed] Disclaimer/Publisher’s Note…

Efficacy of Intra-Operative Topical Wound Anaesthesia to Mitigate Piglet Castration Pain—A Large, Multi-Centred Field Trial 2%
Meredith Sheil, Giulia Maria De Benedictis, Annalisa Scollo, Suzanne Metcalfe, Giles Innocent, Adam Polkinghorne, Flaviana Gottardo · file · #92

…Proof of anaesthetic efficacy is challenging in neonatal piglets, particularly in the “field” or “on-farm” setting as per the VICH GL9 standard [53] required for veterinary drug regulatory approvals. There is…