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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To conduct the essay, is recommended the compliance with the equipment’s manufacturing instructions regarding to obscuration and transmittance percent. 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. We are aware of broken document links caused by a programming error and we are working with the developers to have it corrected in the shortest possible time.

Analysis follows the methods of Brazilian Pharmacopeia using the amount of flasks and the specification in accordance with stated volume. Still, all values of Cmax that were above the limit of quantification, even for the volunteers to whom the AUC was not possible to calculated in some of the treatments, shall be included in statistical analysis of the Cmax. Spray Pattern can be characterized and quantified by manual or automatic image, as long as validated.

Volunteers must be previously trained to use the apparatus that will receive the formulation to inhale properly; Before nasal administration 1 minutevolunteers must blow their noses; During nasal application, one of the nostrils must be obstructed while administration is executed in the other nostril.

Analysis must be capable of evidencing the identity of the active ingredient in samples of the test and the reference drug product. Acceptance of clinical trials conducted in third countries, for evaluation in MAAs: Standard Chemical Substances SQRwhich have been standardized by the Brazilian Pharmacopoeia, and other pharmacopoeia codes authorized by the current legislation, must be employed. In addition, data of two different distances from the laser and the orifice of flasks must be evaluated.


Received Nov 20; Accepted Jan Proceed the analysis using part of the content of ten 10 different flasks, disposing the first actuations necessary for priming, whenever applicable. Such techniques are named resistant or robust. Support Center Support Center. Pharmaceutical Equivalence of Nasal Sprays and Aerosols 3.

The statistical objective is extract valid inferences from a set of data.

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Accessed 5 May Both fast and fed studies are demanded only for prolonged release dosage forms. Guideline for bioanalytical method validation—RDC n.

There must be an application of placebo with the same apparatus to evaluate tolerance of volunteer guifelines receipt of drug without reactions, which, generally, result in sneezing.

In case of any other authorized Pharmacopoeia be used, the requirements of monograph must be complemented guifelines the essays that are described in General Methods of current Brazilian Pharmacopoeia, described for the pharmaceutical form studied. The environment of lab bioeauivalence have enough room to allow that working areas be kept clean and organized.

For suspensions, test must employ the methodology established anvissa available Pharmacopoeia, or a validated methodology in the absence of a Pharmacopeial methodology to determine the delivered dose. It is recommended that time elapsed between first and last actuation does not exceed 1 minute; After last application, volunteers must receive a ml glass of water to conduct particles of drug that might have remained in oral cavity to gastrointestinal tract; Drug must be administered in a room, and volunteers must be led to another room where blood samples will be drawn, minimizing the cross-contamination.


Because the legal framework of the Brazilian Health Surveillance Agency ANVISA is available only in Portuguese, it might have been difficult to search information properly or to identify updated guidelines. Received May 21; Accepted Jun Since then, a series of activities have been conducted, including meetings, conferences, technical visitations and studies follow up to subsidize the knowledge and the course of discussions in Brazil and around the fuidelines.

Current Regulatory Agenda of ANVISA, which contains possible future resolutions to be revised over —, includes a discussion on biowaiver requirements and on possible in vitro and in vivo comparability tests for these products.

Excipients guirelines to affect the bioavailability should be qualitatively the same in the test and reference formulations. The scientific advances, as well as new ideas will be welcomed, always, to contribute for the discussion of this matter, whose main objective is to offer safe, and efficient and quality products to population.

Journal of Bioequivalence & Bioavailability

The bioeqiuvalence comparison should be done by f2 metric. Guidance on aspects of Correlation yielded values are between -1 and 1. Samples, standard reagents and reference materials must be properly stored to warrant their integrity and traceability. Mon Arch Chest Dis. The submitted applications for BCS-based biowaiver should enclose documents that confirm the high solubility of the drug and the similarity of dissolution profiles of the test and reference drug products, which should be rapid or very rapid bbioequivalence 4.

The continuous training must be monitored and capable of identifying improvement needs.