Overview of the Animal Health Drug Development and Registration Process: An Industry Perspective

Hunter, R. P.; Shryock, Thomas R.; Cox, Brian; Butler, R.M.; Hammelman, Jason E

doi:10.4155/fmc.11.55

Cited by 12 publications

(15 citation statements)

References 9 publications

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“…Strong evidence of medication safety issues associated with polypharmacy are common in human medicine. Unfortunately, this is lacking in zoological medicine, in part due to the non-requirement for drug-drug interaction data during the drug approval process for animal health products, as well as a historical lack of awareness of polypharmacy [ 24 ].…”

Section: What Are the Practical Solutions?mentioning

confidence: 99%

Polypharmacy in Zoological Medicine

Hunter

Isaza

2017

Pharmaceutics

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Polypharmacy is a term that describes the inappropriate, concurrent use of multiple drugs in an individual patient. Zoological medicine practitioners must take approved agents (veterinary or human) and extrapolate their use to non-approved species often with little species-specific pharmacological evidence to support their decisions. When considering polypharmacy, even less information exists concerning multi-drug pharmacokinetics, pharmacodynamics, or potential drug-drug interactions in non-domestic species. Unfortunately, captive, zoological species are susceptible, just like their domestic counterparts, to chronic diseases and co-morbidities that may lead to the usage of multiple drugs. Polypharmacy is a recognized and important issue in human medicine, as well as an emerging issue for veterinarians; thus, this paper will discuss the novel, potential risks of polypharmacy in zoological medicine. Hopefully, this discussion will help bring the attention of veterinarians to this issue and serve as an interesting discussion topic for pharmacologists in general.

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Section: What Are the Practical Solutions?mentioning

confidence: 99%

Polypharmacy in Zoological Medicine

Hunter

Isaza

2017

Pharmaceutics

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“…It also allowed recommending more than one drug dosage on the label. Current requirements for approval of a NADA further include that the sponsor sufficiently describes the chemistry, specifics of manufacturing and quality control processes, and assessment of environmental safety of the drug if used per label (Hunter et al, 2011).…”

Section: Findings Of the Reviewmentioning

confidence: 99%

Short history of regulations and approved indications of antimicrobial drugs for food animals in the USA

Volkova

DeMars

2016

Vet Pharm & Therapeutics

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We review historical availability and regulation, and recent indications of antimicrobial drugs for food animals in the USA. We summarize the timeline of introduction of individual antimicrobial drug classes from the 1930s to present, history of regulation of antimicrobial drugs from the 1930s to present and indications of antimicrobial drugs in 1996-2014 for food animals in the USA. The history of antimicrobial drug regulation demonstrates a historical precedent for harmonized regulations of antimicrobials 'for human and other animals' in the USA.

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“…The worldwide animal health market is estimated to be worth $20.1 billion (USD), with the majority of this occurring in the USA and the EU (Hunter et al , 2011). The animal health industries are generally represented by the International Federation for Animal Health (IFAH; ), which is comprised of member companies and other associations () with interests in veterinary medicines, vaccines or other animal health products.…”

Section: Session 5: Regulatory Pathways To Enable the Licensure Of Almentioning

confidence: 99%

“…Although there are a wide variety of alternatives for antibiotics being investigated, the actual number of new commercial antimicrobials with antibiotic-like outcomes marketed has been minimal in number due to a variety of reasons. This has principally been due to the discontinuation of antibiotic research and development by pharmaceutical companies for more profitable drugs that require long-term treatment of human diseases or conditions (Shryock, 2004; Fox, 2006; Hunter et al , 2011). Certainly, intellectual property issues will be of concern because there is apparently no ‘safe harbor research exemption’ for a veterinary biological product manufactured using recombinant DNA or other site-specific genetic techniques in the USA (Lu et al , 2011).…”

Section: Session 5: Regulatory Pathways To Enable the Licensure Of Almentioning

confidence: 99%

Alternatives to antibiotics: a symposium on the challenges and solutions for animal production

Seal

Lillehoj

Donovan

2013

Anim. Health. Res. Rev.

151

110

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Antibiotics are one of the most important medical discoveries of the 20th century and will remain an essential tool for treating animal and human diseases in the 21st century. However, antibiotic resistance among bacterial pathogens and concerns over their extensive use in food animals has garnered global interest in limiting antibiotic use in animal agriculture. Yet, limiting the availability of medical interventions to prevent and control animal diseases on the farm will directly impact global food security and safety as well as animal and human health. Insufficient attention has been given to the scientific breakthroughs and novel technologies that provide alternatives to antibiotics. The objectives of the symposium 'Alternatives to Antibiotics' were to highlight promising research results and novel technologies that could potentially lead to alternatives to conventional antibiotics, and assess challenges associated with their commercialization, and provide actionable strategies to support development of alternative antimicrobials. The symposium focused on the latest scientific breakthroughs and technologies that could provide new options and alternative strategies for preventing and treating diseases of animals. Some of these new technologies have direct applications as medical interventions for human health, but the focus of the symposium was animal production, animal health and food safety during food-animal production. Five subject areas were explored in detail through scientific presentations and expert panel discussions, including: (1) alternatives to antibiotics, lessons from nature; (2) immune modulation approaches to enhance disease resistance and to treat animal diseases; (3) gut microbiome and immune development, health and diseases; (4) alternatives to antibiotics for animal production; and (5) regulatory pathways to enable the licensure of alternatives to antibiotics.

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Overview of the Animal Health Drug Development and Registration Process: An Industry Perspective

Cited by 12 publications

References 9 publications

Polypharmacy in Zoological Medicine

Polypharmacy in Zoological Medicine

Short history of regulations and approved indications of antimicrobial drugs for food animals in the USA

Alternatives to antibiotics: a symposium on the challenges and solutions for animal production

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