Guidance for Organizations performing in vivo Bioequivalence Note: ANVISA is constantly redesigning its website starting in Aug Anvisa-Guidance-for-Pharmaceutical-Equivalence-and-Bioequivalence-of-Nasal -Sprays-and-Aerosols_生物学_自然科学_专业资料。Agência. Since , ANVISA has been publishing several Resolutions to establish criteria and requirements to conduct a bioequivalence Trial to register drugs that have.

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Quality Assurance and GLP: Advanced Drug Delivery Reviews, v. Considering that drugs administered by nasal route reach low plasmatic concentrations, doses administered can be equal, or higher, than therapeutic doses, as long as safety of volunteers is warranted. Copies available at our site are denoted by bioeqkivalence icon: In this note, we would like to comment a recently published review article on the similarities and differences among some international jurisdictions in accepting bioequivalence approaches bioequivalenve generic topical dermatological drug products [ 1 ].

Pharmacopoeia Trials to Nasal Sprays and Aerosols 4.

Journal of Bioequivalence & Bioavailability

Samples, standard reagents and reference materials must be properly stored to warrant their integrity and traceability. For solutions, dose can be gravimetrically determined from the weight of the delivered dose, the concentration, and the density of tested solution. Therefore, plasmatic concentrations of drugs that are administered by nasal route result from local and oral absorption.

To bioequivalwnce reproducibility of collection of samples, the employment of mechanical actuation methods is recommended. Pharmacodynamic Studies for Nasal Sprays and Aerosols. Published online Jun In the continuous process of revising and updating regulatory recommendations, it is essential that international regulatory authorities and organizations share their experiences.


Each volunteer must receive drug by an individual flask; All volunteers and staff must wear clean area clothing, including caps, masks, and gloves; Before each application, the device must be tested by trained staff and execution of about 5 actuations is recommended, outside the building, on the day prior to the testing day; Flasks must be weighted after 5 guidelinees and, again, after administration in the volunteers. Another exclusion criteria used for nasal sprays and aerosols is the occurrence of a sneeze two hours after administration of the drug.


Consideration for equivalence includes formulation general aspect, pH, viscosity, density, drug active concentration assay, and microbiological tests results [ 4 ]. There must be an application of placebo with the same apparatus to evaluate tolerance of volunteer to receipt of drug without reactions, which, generally, result in sneezing.

Global Bioequivalence / Bioavailability Regulatory Guidance Documents §¯`·.¸¸.·´¯`·.¸¸.

Follow the general methods of current Brazilian Pharmacopeia. It is important to highlight that only BE studies conducted by certified contract research organizations CROs are accepted to support the registration of a generic drug product.

The environment of lab must have enough room to allow that working areas be kept clean and organized. In this context, we would like to clarify some misunderstood definitions. Bioavailability of fluticasone propionate and mometasone furoate aqueous nasal spray. Exclusions must be documented and justified in Final Report.

These drugs, mainly, are used to treat allergic rhinitis. Essay must be conducted using 10 flasks of test drug and 10 of reference drug. Description must follow Brazilian Pharmacopeia; 3. Upon the end of the period under the terms of the Article One, the National Health Surveillance Agency shall join other involved Bodies and Institutions and those who stated interest in the matter to indicate representatives for further discussions to gjidelines a final text.

Whatever is not mentioned here is correctly stated in the article. Pharmaceutical Equivalence of Nasal Sprays and Aerosols The Pharmaceutical Equivalence consists in verifying if test drug T complies, integrally, with the specifications of the Pharmacopoeia and with the remaining performance tests as described in the Guidance, and if results obtained are equivalent to the results of reference drug R. Thank you for your patience.

Such techniques are guidellnes resistant or robust. Author information Article notes Copyright and License information Disclaimer. Pharmacodynamic studies must comply with the following criteria: The use of surfactants is prohibited, and enzymes are allowed for gelatin capsules only. Presentation of Biopharmaceutical and Bioanalytical Data in Module 2.

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Plumes generated by actuation of this kind of drug products can be characterized in three stages: Data and documents generated must be submitted, as fo as essay execution SOP. The profile comparison should be done by f2 metric. However, it is noted that several of these drugs are formulated as a suspensions. Bioeqiivalence online Feb 4.


Regarding the dose strength used in the in vivo studies, a guideline published in RDC n. Standard Chemical Substances SQRwhich have been standardized by the Brazilian Pharmacopoeia, and other pharmacopoeia codes authorized by the current legislation, must be employed.

Analysis of distribution of size of particle: The analytical method for assay shall yield the determination of the quantity of active ingredient in each delivered dose and the data must be reported as percents of labeled dose. Volunteers whose quantification of drug in biological samples were above limit of quantification in less than 4 collection points in one of the treatments, and to whom the quantification of samples displays sufficiently expressive issues that impair comparison between test and reference performance must be excluded from the study.

Received May 21; Accepted Jun Pharmaceutical Equivalence of Nasal Sprays and Aerosols 3. It mentions also that the number of subjects in a BE study should be at least 12, but in the case of unknown within-subject variability, the researcher should opt to use a minimum of 24 subjects. In the absence of Pharmacopeial method, the study must be undertaking using a method that has been validated by test drug product manufacturer and must be co-validated by the study executer lab, with the complementation of essays described in General Methods of current Brazilian Pharmacopoeia.

Received Nov 20; Accepted Jan Simple actuation must be executed at beginning dose following the preparation in two distances defined between orifice of flask and the impact surface, of at least 3 cm, within 3 to 7 cm variation.