Roteiros de análise e referências técnicas
ROTEIROS
1. Roteiro de ANÁLISE PRÉVIA/TRIAGEM.
4. Roteiro para análise de estudos de DEPLEÇÃO DE RESÍDUOS – etapa analítica e validação.
11. Roteiro para análise de estudos de EFICÁCIA ANTIPARASITÁRIA.
12. Roteiro para análise de etapa analítica e método analítico de estudo de ESTABILIDADE.
13. Roteiro para análise de estudos de ESTABILIDADE – conclusão.
14. Roteiro para análise de relatório de PARTIDA PILOTO ou comercial – produtos farmacêuticos.
15. Roteiro para análise de estudos de SEGURANÇA na espécie-alvo.
(em breve!) REFERÊNCIAS TÉCNICAS
BOAS PRÁTICAS CLÍNICAS:
VICH GL9 – Good Clinical Practice.
EMA/CVMP/EWP/81976/2010 – Guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals)
DEPLEÇÃO DE RESÍDUOS:
EMA/CVMP/SWP/735325/2012 - Guideline on determination of withdrawal periods for edible tissues.
EMEA/CVMP/473/98-FINAL – Note for guidance for the determination of withdrawal periods for milk.
EMEA/CVMP/036/95-FINAL – Note for guidance: Approach towards harmonization of withdrawal periods.
EMEA/CVMP/187/00-FINAL – Note for guidance on the risk analysis approach for residues of veterinary medicinal products in food of animal origin.
VICH GL48 – Studies to evaluate the metabolism and residue kinetics of veterinary drugs in foodproducing animals: marker residue depletion studies to establish product withdrawal periods
EFICÁCIA:
EMA/CVMP/016/2000-REV.3 – Guideline on the conduct of bioequivalence studies for veterinary medicinal products.
EMA/CVMP/344/1999 REV. 2 – Guideline for the conduct of efficacy studies for intramammary products for use in cattle.
EMA/CVMP/EWP-1061-2001 – Guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs.
EMA/CVMP/EWP/206024/2011 – Guideline on the demonstration of palatability of Veterinary medicinal products.
EMA/CVMP/EWP/459868/2008 – Guideline on demonstration of target animal safety and efficacy of veterinary medicinal products intended for use in farmed finfish.
EMEA/CVMP/133/99 FINAL – Guidelines for the conduct of pharmacokinetic studies in target animal species.
VICH GL52 – Bioequivalence: blood level bioequivalence study.
EFICÁCIA DE ANTIMICROBIANOS:
EMA/CVMP/627/2001 REV. 1 – Guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances.
EFICÁCIA DE ANTIPARASITÁRIOS:
VICH GL7 – Efficacy of Anthelmintics: general requirements.
VICH GL12 – Efficacy of Anthelmintics: specific recommendations for bovines.
VICH GL13 – Efficacy of Anthelmintics: specific recommendations for ovines.
VICH GL14 – Efficacy of Anthelmintics: specific recommendations for caprines.
VICH GL15 – Efficacy of Anthelmintics: specific recommendations for equines.
VICH GL16 – Efficacy of Anthelmintics: specific recommendations for porcines.
VICH GL19 – Efficacy of Anthelmintics: specific recommendations for canines.
VICH GL20 – Efficacy of Anthelmintics: specific recommendations for felines.
VICH GL21 – Efficacy of Anthelmintics: specific recommendations for poultry – Gallus gallus.
WAAVP – Guideline: Anthelmintic combination products targeting nematode infections of ruminants and horses.
WAAVP – Guidelines for evaluating the efficacy of anthelmintics for dogs and cats.
WAAVP – Guidelines for evaluating the efficacy of anthelmintics in ruminants (bovine and ovine).
WAAVP – Guidelines for evaluating the efficacy of anticoccidial drugs in chickens and turkeys.
WAAVP – Guidelines for evaluating the efficacy of ectoparasiticides against biting and nuisance flies on ruminants.
WAAVP – Guidelines for evaluating the efficacy of equine anthelmintics.
WAAVP – Guidelines for evaluating the efficacy of parasiticides flea and tick infestation on dogs and cats.
WAAVP – Guidelines for evaluating the effectiveness of anthelmintics in chickens and turkeys.
WAAVP – Guidelines for evaluating the efficacy of acaricides against (mange and itch) mites on ruminants.
WAAVP – Guidelines for evaluating the efficacy of ectoparasiticides against myiasis causing parasites on ruminants.
WAAVP – Guidelines for evaluating the efficacy of acaricides against ticks (Ixodidae) on ruminants.
WAAVP – Guidelines for evaluating the efficacy of anthelmintics in ruminants (bovine,ovine,caprine).
WAAVP – Guidelines for evaluating the efficacy of anthelmintics in swine.
WAAVP – Guidelines efficacy of parasiticides flea and tick infestations on dogs and cats.
WAAVP – Guidelines for the detection of anthelmintic resistance in nematodes of veterinary importance.
WAAVP – Guideline for evaluating the efficaccy of anticoccidial in mammals (pigs, dogs, cattle, sheep).
WAAVP – Guideline for the evaluation of drug efficacy against non-coccidial gastrointestinal protozoa in livestock and companion animals.
WAAVP – Second edition of guidelines for evaluating the efficacy of anthelmintics in swine.
WAAVP – Second edition of guidelines for evaluating the efficacy of equine anthelmintics.
WAAVP – Guideline for testing the efficacy of ectoparasiticides for fish.
ESTABILIDADE:
VICH GL51 - Statistical Evaluation of Stability Data
VICH GL58 - Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV
SEGURANÇA:
VICH GL43 – Target animal safety for veterinary pharmaceutical products.
EMA/CVMP/EWP/459868/2008 – Guideline on demonstration of target animal safety and efficacy of veterinary medicinal products intended for use in farmed finfish.
VALIDAÇÃO DE MÉTODOS ANALÍTICOS:
Guia de validação e controle de qualidade analítica - CGAL/SDA/MAPA – Fármacos em produtos para alimentação animal e medicamentos veterinários.
VICH GL2 – Guideline on validation of analytical procedures: methodology.
VICH GL49 – Studies to evaluate the metabolism and residues kinetics of veterinary drugs in human food-producing animals: validation of analytical methods used in residue depletion studies.
RDC nº 27, de 17 de maio de 2012 - ANVISA – Dispõe sobre os requisitos mínimos para a validação de métodos bioanalíticos empregados em estudos com fins de registro e pós-registro de medicamentos.
RDC nº 166, de 24 de julho de 2017 – ANVISA – Dispõe sobre a validação de métodos analíticos e dá outras providências.
DOQ-CGRE 008 – INMETRO – Orientação sobre validação de métodos analíticos.