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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Training Workshop on P Editora Atheneu,; – 16 relation on efficacy and safety. Follow the general methods of current Brazilian Pharmacopeia. Before beginning clinical phase, volunteers must receive training regarding administration of drugs.

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

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 ]. In the continuous process of revising and updating regulatory recommendations, it is essential that international regulatory authorities and organizations share their experiences.

Test must be conducted in unities that have been primed in accordance with the instructions of use. For suspensions, the dose must be released in a proper recipient, which might allow the due transfer of the content.

The environment of lab must have enough room to allow that working areas be kept clean and organized. Inform that the Resolution proposal shall be availed, in its totality, during the consultation period at the address http: 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 application, one of the nostrils must be obstructed while administration is executed in the other nostril.

Essay must be conducted using 10 flasks of test drug and 10 of reference drug. Another exclusion criteria used for nasal sprays and aerosols is the occurrence of a sneeze two hours after administration of the drug. It is recommended that time elapsed between first and guiidelines actuation does 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.


There must be an application giudelines placebo with the same apparatus to evaluate tolerance of volunteer to receipt of drug without reactions, which, generally, result in sneezing. Upon the end of the period under the terms of the Article One, the National Health Surveillance Agency shall join other involved Bodies guiddelines Institutions and those who stated interest in the matter to indicate representatives for further discussions to consolidate a final text.

Mechanical actuation proceedings must guidelinew controls that are adequate for critical parameters such as actuation strength, speed, and time interval between actuations.

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.

Waiver of In Vivo Bioa 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.

For solutions, dose can be gravimetrically determined from the weight of the delivered dose, the concentration, and the density of tested solution.

Study must be conducted, preferably, with one single dosage, and multiple dose studies must be justified in protocol. Therefore, only in vitro studies are required for registration of all generic topical dermatological drug products, including those containing corticosteroids. Pharmacodynamic studies must comply with the following criteria: Description must follow Brazilian Pharmacopeia; 3. Guidance on aspects of Gelfusoand Tais Gratieri.

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.

Journal of Bioequivalence & Bioavailability

Multisource generic pharmaceutical products: 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 ].


Pharmaceutical Equivalence of Nasal Sprays and Aerosols 3. Determination of nominal volume in liquid products with multiple doses is executed by content weight. 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.

Pharmacodynamic Studies for Nasal Sprays and Aerosols. Uniformity of Delivered Dose: The average volume must be determined, only, for drugs whose volumes are stated on the label. Drugs that are administrated by nasal route display a characteristic pharmacokinetic behavior, which is absorption by two distinct routes: Plumes generated by actuation of this kind of drug products can be characterized in three stages: Analysis of the Uniformity of DeliverdDose: Accepted in February, 29th, Survey of international regulatory bioequivalence recommendations for approval of generic topical dermatological drug products.

GL on multiplicity issues in clinical trials: Presentation of Biopharmaceutical and Bioanalytical Data in Module bioequivalenve. A detailed description of test anvixa reference drug products as to appearance colorcharacteristic odor, viscosity, presence of particles to characterize each one of them.

The continuous training must be monitored and capable of identifying improvement needs. Trials employing working standards, as long as the certification is evidenced, in absence of SQR, shall be admitted. 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. It is recommended that design and evaluation parameters of the study be previously discussed and submitted to ANVISA as a protocol.

This Resolution shall be in effect on the date of its publication.