Guidance for Organizations performing in vivo Bioequivalence Note: ANVISA is constantly redesigning its website starting in Aug ANVISA. BRAZILIAN HEALTH REGULATORY AGENCY. Brazilian REPRESENT ADVICE OR GUIDANCE . BIOEQUIVALENCE. Anvisa regulatory guidelines High Impact List of Articles PPts Journals Bioequivalence Journal · Pharmaceutical Analysis Journal · Pharmacovigilance.

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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 world. National Health Surveillance Agency.

Mechanical actuation proceedings must hold controls that are adequate for critical parameters such as actuation strength, speed, and time interval between actuations. Follow official methodology and specification for each bioequivakence ingredient; 3. The environment of lab must have enough room to allow that working areas be kept clean and organized. Nonetheless, only the post-approval guidance RDC48, of October 6thhas mentioned the need to assess the drug permeability of topical dermatological anviza, although this guidance has not specified the experimental procedures to be followed [ 6 ].

According to Resolutions RE n. In spite of the mention of such pharmacodynamic tests, they are not required for topical dermatological drug product approval, as suggested in Tables II and III of the aforementioned review.

The space must be proportional to anviss volume of analysis conduced and to internal organization of lab. Though the objective of these drugs is local action, consequences of systemic absorption, such as suppression of the hypothalamus-pituitary-adrenal HPA axismust be taken into consideration.

In the continuous process of revising and updating regulatory recommendations, it is essential that international regulatory authorities and organizations share their experiences. The matter is complex and originates diverging opinions and this proposal does not represent the depletion of this discussion.

The results obtained for test drug Bioequivalwnceshall be compared to the results of the reference drug Rthus, determining existence or lack of Pharmaceutical Equivalence. Presentation of Biopharmaceutical and Bioanalytical Data in Module 2. Schedule of collection of samples must warrant proper characterization of plasmatic profile of drugs, however it must be considerate, besides half-life of elimination, the capability of analytical method to quantify drug by proposed period.



The number of doses generated by each of the unities tested must be counted and related to the declared by manufacturer. Actuations must be conducted in accordance with procedure described in label. Objective The objective of this document is to introduce a series of recommendations and requirements for the execution of Pharmaceutical Equivalence and Bioequivalence trials with nasal sprays and aerosols, listing the necessary essays, methodology and the data to be submitted to ANVISA to prove safety and efficacy of these drugs boequivalence registration as a generic and similar drug.

It is recommended a distance of 2 to 7 cm between the laser and the orifice, and that they hold a detachment of 3 cm, or more, between them.

Linear association measured between two variables.

The essays that are required to evidence Pharmaceutical Equivalence of these drugs are: Weightings are executed by bioequivaleence scale with proper sensitivity, duly calibrated. The average volume must be determined, only, for drugs whose volumes are stated on the label. Provides information about pharmaceutical equivalence determination and dissolution profile comparison.

Journal of Bioequivalence & Bioavailability

The continuous training must be monitored and capable of identifying improvement needs. In addition to considering the data itself, any analysis is based on some hypothesis or assumptions regarding study situation.

In addition, data of two different distances from the laser and the orifice of flasks must be evaluated. Waiver of In Vivo Bioa Only the analysts who are able to evidence competency, or who are properly supervised, might conduct the Pharmaceutical Equivalence essays.

The closer they are from the extremes guidlines or 1 the stronger is the linear association between the studied variables: BCS -based Biowaivers; M 9: Received May 21; Accepted Jun The statistical objective is extract valid inferences from a set of data. National Center for Biotechnology InformationU.

Pharmaceutical Regulatory Affairs: Open Access

The choice of the dose must be justified in the protocol and the study shall not be started before protocol is authorized by Independent Ethics Committee. Follow official methodology and specification of each active ingredient. 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.


The batches must be submitted in parallel to the essays established in the monograph of the Brazilian Pharmacopoeia or remaining official publications, as per the current Resolutions and the referred Guidance.

The current guideline describes how pharmacokinetics tests should be performed for those medicines requiring a demonstration of blood level bioequivalence bioeqkivalence, in cases where it is not possible to precisely and accurately quantify the drug in circulation, when gidelines measurements may be accepted. Quality Assurance and GLP: Plumes generated by actuation of this kind of drug products can be characterized in three stages: For solutions, must be determined the relative mass of each actuation per flask by differences in weight before and after actuation.

National Health Surveillance Agency 1. Proceed the analysis using part anvjsa the content of ten 10 different flasks, disposing the first actuations necessary for priming, whenever applicable.

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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 anvisaa, one of the nostrils must be obstructed while administration is executed in the other nostril. Training Workshop on P 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.

Editora Atheneu,; – 16 relation on efficacy and safety. Pharmaceutical Equivalence of Nasal Sprays and Aerosols 3. Brazilian Health Surveillance Agency. Test must be executed with the vertical, or close to the vertical positioning of flasks.