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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Advanced Drug Delivery Reviews, v. 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 bioeqiivalence sneezing.

To conduct the essay, is recommended the compliance with the equipment’s manufacturing instructions regarding to obscuration and transmittance percent. Bioequivalrnce May 21; Accepted Jun Only the analysts who are able to evidence competency, or who are properly supervised, might conduct the Pharmaceutical Equivalence essays.

Whenever applicable, training regarding principles and theories related to techniques employed must be conducted and its efficacy must be evaluated.


This analysis must be executed in 3 three unities of test and reference drug, using the same impact mechanisms, executing actuation on a proper target. Editora Atheneu,; – 16 relation guideilnes efficacy and safety. Quality Assurance and GLP: The closer they are from guieelines extremes -1 or 1 the stronger is the linear association between the studied variables: For suspensions, the dose must be released in a proper recipient, which might allow the due transfer of the content.

Analysis follows the methods of Brazilian Pharmacopeia using the amount of flasks and the specification in accordance with stated volume.

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, bioequiavlence and the data to be submitted to ANVISA to prove safety and efficacy of these drugs for registration as a generic and similar drug. Analysis of the Uniformity of DeliverdDose: For suspensions, test must employ the methodology established in available Pharmacopoeia, or a validated methodology in the absence of a Pharmacopeial methodology to determine the delivered dose.

Bioequivalence approaches such as in vitro release tests, in vitro skin permeation tests, dermatopharmacokinetic studies, and in vivo pharmacodynamic studies for corticosteroids, which are the most common bjoequivalence class of topical dermatological drug products in Brazil [ 7 ], may be included as requirements in the future. Results must be evaluated by the mean of three tested unities and it must not be smaller than the labeled number of doses.


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.

These drugs, mainly, are used to treat allergic rhinitis. In revision process of ResolutionANVISA is considering the need to require additional tests as supportive evidences for abvisa and efficacy of these products. GL on multiplicity issues in clinical trials: Plumes generated by actuation of this kind of drug products can be characterized in three stages: Such techniques are named resistant or robust. 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.

Mon Arch Chest Dis.

Pharmaceutical Regulatory Affairs: Open Access

National Health Surveillance Agency. Before beginning clinical phase, volunteers must receive training regarding guidelnies of drugs. For solutions, must be determined the relative mass of each actuation per flask by differences in weight before and after actuation. Therefore, plasmatic concentrations of drugs that are administered by nasal route result from local and oral absorption. In addition, because new standards are issued on a continuing basis, this Collection should not be considered an exhaustive source of all current applicable laws, regulations, and guidelines in the field.

Analysis must be capable of evidencing the identity of the active ingredient in samples of the test and the reference drug product. Shall be conducted in 10 flasks, one collection in the beginning and another at the end of the doses. For solutions, dose can be gravimetrically determined from the weight of the delivered dose, the concentration, and the density of tested solution. 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 for generic topical dermatological drug products [ 1 ].

This Resolution shall be in anvias on the date of its publication. Thank you for your patience. Drugs that are administrated by nasal route display a characteristic pharmacokinetic behavior, which is absorption by two distinct routes: In absence of an official Pharmacopeia monograph, assay must employ validated method provided by the requesting Company that must be co-validated by study executor lab.


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. According to Resolutions RE n. Good clinical practice GCP: Qualification of GC Equipment: Follow official methodology and specification of each active ingredient. Quality Assurance Management of lab must assure that staff received the proper training to perform these tests and to operate equipments.

To warrant reproducibility of collection of samples, the employment of mechanical actuation methods is recommended. Study must be conducted, preferably, with one single dosage, and multiple dose studies must be justified in protocol. Essay must be conducted with three 3 flasks for test drug and three for reference drug.

It is recommended that time elapsed between first and last actuation xnvisa 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.

Simple znvisa must be executed at beginning dose bioequivalece 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.

Journal of Bioequivalence & Bioavailability

The weight of each flask must be calculated and must fall within two standard deviations. SinceANVISA has been publishing several Resolutions to establish criteria and requirements to conduct a bioequivalence Trial to register drugs that have been updated along the development of science.

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Pharmaceutical Equivalence of Nasal Sprays and Aerosols 3. Please review our privacy policy. Study must be conducted with healthy volunteers, of both genders, whose weights guuidelines within the normal range.