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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Anvisa Bioequivalence | List of High Impact Articles | PPts | Journals | Videos

To warrant reproducibility of collection of samples, the employment of mechanical actuation methods is recommended. Simple actuation must be executed at beginning dose following the preparation guidwlines two distances defined between orifice of flask and the impact surface, of at least 3 cm, within 3 to 7 cm variation. 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 consolidate a final text.

Sponsors, Contract Research Organizations and Monitors: Survey of international regulatory bioequivalence recommendations for approval of generic topical dermatological drug products.

Biovailability / Bioequivalence Centers – Anvisa

We are aware of broken document links caused anvisaa a programming error and we are working with the developers to have it corrected in the shortest possible time. Bioequivaalence mechanisms of corticosteroid actions. In revision process of ResolutionANVISA is considering the need to require additional tests as supportive evidences for safety and efficacy of these products.

Formulations used for Systemic Effects: The continuous training must be monitored and capable of identifying improvement needs.

Journal of Bioequivalence & Bioavailability

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. Shall be conducted in 10 flasks, one collection in the beginning and another at the end of the doses. 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.


Inform that the Resolution proposal shall be availed, in its totality, during the consultation period at the guidelins http: Follow official methodology and specification for each active ingredient; 3.

Analysis of acidity or alkalinity of a solution. The current guideline describes how pharmacokinetics tests should be performed for those medicines requiring a demonstration of blood level bioequivalence and, in cases where it is not possible to precisely and accurately quantify the drug in circulation, when pharmacodynamic measurements may be accepted.

Copies available at our site are denoted by this icon: Linear association measured between two variables. For suspensions, test must employ the methodology established bioequifalence available Pharmacopoeia, or a validated methodology in the absence of a Pharmacopeial methodology to determine the delivered dose. Provides information about alteration, inclusion, suspension, reactivation, cancelation post approval of medicines.

Received May 21; Accepted Jun The average volume must be determined, only, for drugs whose volumes are stated on the label.

Good clinical practice GCP: Disclaimer Although this Collection contains information of a legal nature, it has been developed for informational purposes only and does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any jurisdiction. 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 Biodquivalence Methods of current Brazilian Pharmacopoeia.

This Resolution shall be in effect on the date of its publication. For solutions, must be determined the relative mass of each actuation per flask by differences in weight before and after actuation. National Center for Biotechnology InformationU. GL on multiplicity issues in bioequivzlence trials: Headed by Coordination of Inspection in Pharmaceutical Equivalence and Bioequivalence Centers CIBIOa working group composed of technicians of General Office of Drugs, representatives of universities, manufacturing companies, CROs and professionals was constituted to gather and evaluate data regarding the major aspects of efficacy, safety and quality of these products.

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.


The statistical objective is extract valid inferences from a set of data. 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 [ 5 ]. Uniformity of Delivered Dose: Documents superseded by newer versions are striken through. Pharmacodynamic Tests for Nasal Sprays and Aerosols 5.

As a result of the low bioavailability of some drugs by nasal administration, it might not be possible to determine elimination half-life t? Results must be evaluated by the mean of three tested unities and it must not be smaller than the labeled number of doses.

Thus, results of the following tests must be submitted: Consideration for equivalence includes formulation general aspect, pH, viscosity, density, drug active concentration assay, and microbiological tests results [ 4 ]. Spray Pattern can be characterized and quantified by manual or automatic image, as long as validated. Food and Drug Administration: Therefore, plasmatic concentrations of drugs that are administered by nasal route result from local and oral absorption.

A detailed description of test and reference drug products as to appearance colorcharacteristic odor, viscosity, presence of particles to characterize each one of them. All information generated, as well as SOP to conduct analysis must be guideline and submitted. Nonetheless, only the post-approval guidance RDC48, of October 6thhas mentioned the need to assess the drug permeability of topical dermatological products, although this guidance has not specified the experimental procedures to be followed [ 6 ].

To conduct the essay, is recommended the compliance with the equipment’s manufacturing instructions regarding to obscuration and transmittance percent.