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 weight of flasks after administration is an exclusion criteria, and the mean of the values. Multisource generic pharmaceutical products: Weightings are executed by a scale with proper sensitivity, duly calibrated. 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.

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 environment of lab must have enough room to allow that working areas be kept clean and organized.

As a result of the low bioavailability of some drugs by nasal administration, it might not be possible to determine elimination half-life t? Brazilian Health Surveillance Agency.

Journal of Bioequivalence & Bioavailability

Consideration for equivalence includes formulation general aspect, pH, viscosity, density, drug active concentration assay, and microbiological tests results [ 4 ]. Guidance on aspects of Characterizes the form and the density of the plume generated by both test and reference spray, using non-impact mechanisms, with visualization by laser light or impact mechanism system, using a proper target that must allow the visualization of the generated spray. The determination of uniformity of delivered dose must be executed in accordance with the following description, taking into account the Pharmacopeia methodology available and assay method for the active bioequivvalence.


Trials employing working standards, as long as the certification is evidenced, in absence of SQR, shall be admitted. 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 ].

Plumes generated by actuation of this kind of drug products can be characterized in three bioequivslence Data and documents generated must be submitted, as well as essay execution SOP.

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.

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.

Another exclusion criteria used for nasal sprays and aerosols is the occurrence of a sneeze two hours after administration of the drug. 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 gioequivalence professionals was biodquivalence to gather and evaluate data regarding the major aspects of efficacy, safety and quality of these products.

Presentation of Biopharmaceutical and Bioanalytical Data in Module 2.

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

Though the objective of these drugs is local action, consequences of systemic absorption, such as suppression of the hypothalamus-pituitary-adrenal HPA bioequivaencemust be taken into consideration. Study must be conducted, preferably, with one single bioequivlaence, and multiple dose studies must be justified in protocol. All information generated, as well as SOP to conduct analysis must be printed and 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.

Pharmaceutical Regulatory Affairs: Open Access

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.


Accepted in February, 29th, In this note, guideliness would like to comment a recently published review article on the similarities and differences among some international jurisdictions in accepting bioeqiuvalence approaches for generic topical dermatological drug products [ 1 ].

Test must be conducted in unities that have been primed in accordance with the instructions of use. Follow the general methods of current Brazilian Pharmacopeia.

According to the Resolution RDC n.

Anvisa regulatory guidelines | List of High Impact Articles | PPts | Journals | Videos

Only the analysts who are able to evidence competency, or who are properly supervised, might conduct the Pharmaceutical Equivalence essays. To conduct the essay, is recommended the compliance with the equipment’s manufacturing instructions regarding to obscuration and transmittance percent. Study must be conducted with healthy volunteers, of both genders, whose weights are within the normal range. Bioequivalence of dermatological topical medicines: Before beginning clinical phase, volunteers must receive training regarding administration of drugs.

Provides information about alteration, inclusion, suspension, reactivation, cancelation post approval of medicines. Support Center Support Center. Pharmacodynamic Studies for Nasal Sprays and Aerosols. Please review our privacy policy. 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.

Sponsors, Contract Research Organizations and Monitors: The weight of each flask must be calculated and must fall within two standard deviations.