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


Inform that the Resolution proposal shall be availed, in its totality, during the consultation period at the address http: The number of doses generated by each of the unities tested must be counted and related to the declared by manufacturer. Advice on the design of BE studies: Bioavailability and bioequivalence trials for nasal aerosols and nasal sprays for local action, Draft, National Health Surveillance Agency.

Volunteers, in order to be included in these studies, must be submitted in a clinical evaluation, and no respiratory disease must be found, which includes allergic rhinitis, nasal septal debytion, and adenoid, as they might alter deposition of drug into nasal mucous.

For suspensions, the dose must be released in a proper recipient, which might allow the due transfer of the content. Inflammation of a CRO in order to comply with written instructions rather than following common sense. The weight of each flask must be calculated and must fall within two standard deviations. Actuations must be conducted in accordance with procedure described in label. Analysis must be capable of evidencing the identity of the active ingredient in samples of the test and the reference drug product.

Initially, all volunteers who had all samples collected must be included in analysis. 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.

Analysis of the Charge and Recharging data: Received May 21; Accepted Jun 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.


Bioavailability of fluticasone propionate and mometasone furoate aqueous nasal spray. The weight of flasks after administration is an exclusion criteria, and the mean of the values. Analysis follows the methods of Brazilian Pharmacopeia using the amount of flasks and the specification in accordance with stated volume. Test must be executed with the vertical, or close to the vertical positioning of flasks.

Weightings are executed by a scale with proper sensitivity, duly calibrated. Spray Pattern can be characterized and quantified by manual or automatic image, as long as validated.

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.

For solutions, must be determined the relative mass of each actuation per flask by differences in weight before and after actuation. Follow the general methods of current Brazilian Pharmacopeia.

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

Before beginning clinical phase, volunteers must receive training regarding administration of drugs. It is recommended that design and evaluation parameters of the study be previously discussed and submitted to ANVISA as a protocol.

Journal of Bioequivalence & Bioavailability

Multisource generic pharmaceutical products: Uniformity of Delivered Dose: Provides information about alteration, inclusion, suspension, reactivation, cancelation post approval of medicines. Thus, results of the following tests must be submitted: 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.

Quality Assurance and GLP: BCS -based Biowaivers; M 9: According to Resolutions RE n. 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 actuations and, again, after administration in the volunteers.


Please review our privacy policy. Another exclusion criteria used for nasal sprays and aerosols is the occurrence of a sneeze two hours after administration of the drug.

Pharmaceutical Regulatory Affairs: Open Access

Presentation of Biopharmaceutical and Bioanalytical Data in Module 2. Qualification of GC Equipment: 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 ].

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 therapeutic class of topical dermatological drug products in Brazil [ 7 ], may be included as requirements in the future. Consideration for equivalence includes formulation general aspect, pH, viscosity, density, drug active concentration assay, and microbiological tests results [ 4 ].

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. Only the analysts who are able to evidence competency, or who are properly supervised, might conduct the Pharmaceutical Equivalence essays. Advanced Drug Delivery Reviews, v. Guidance on aspects of Therefore, only in vitro studies are required for registration of all generic topical dermatological drug products, including those containing corticosteroids.

National Center for Biotechnology InformationU. Good clinical practice GCP: 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. 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.