Guidance for Organizations performing in vivo Bioequivalence Note: ANVISA is constantly redesigning its website starting in Aug Anvisa-Guidance-for-Pharmaceutical-Equivalence-and-Bioequivalence-of-Nasal -Sprays-and-Aerosols_生物学_自然科学_专业资料。Agência. Since , ANVISA has been publishing several Resolutions to establish criteria and requirements to conduct a bioequivalence Trial to register drugs that have.

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Global Bioequivalence / Bioavailability Regulatory Guidance Documents §¯`·.¸¸.·´¯`·.¸¸.

Spray Pattern can be characterized and quantified by manual or automatic image, as long as validated. National Center for Biotechnology BioequicalenceU. Data and documents generated must be submitted, as well as essay execution SOP.

Food and Drug Administration: Linear association measured between two variables. Study must be conducted with healthy volunteers, of both genders, whose weights are within the normal range.

Inform that the Resolution proposal shall be availed, in its totality, during the consultation period at the address http: It mentions also that the number of subjects in a BE study should be at least 12, but in the case of unknown within-subject variability, the researcher should opt to use a minimum of 24 subjects.

gukdelines Operational parameters and conditions that were established for equipment, also, must be submitted. Mechanical actuation proceedings guidellnes hold controls that are adequate for critical parameters such as actuation strength, speed, and time interval between actuations.

Pharmacopoeia Trials to Nasal Sprays and Aerosols 4. Guidance on aspects of 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. Description must follow Brazilian Pharmacopeia; 3.


Pharmaceutical Equivalence of Nasal Sprays and Aerosols 3.


For solutions, must be determined the relative mass of each actuation per flask by differences in weight before and after actuation. For suspensions, the dose must be released in a proper recipient, which might allow the due transfer of the content.

The profile comparison should be done by f2 metric. A new approach to char National Abvisa Surveillance Agency 1. 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 ]. 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 fod and aerosols, listing the necessary essays, methodology and the data to be submitted to ANVISA to prove safety and efficacy of these drugs for registration as a generic and similar drug.

Journal of Bioequivalence & Bioavailability

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

Regarding the dose strength used in the in vivo studies, a guideline published in RDC n. The weight of flasks after administration is an exclusion criteria, and the mean of the values. Successful approaches implemented internationally could lead to a global alignment in regulatory requirements and would improve the efficacy of topically administered generic formulations.

Published online Feb 4. Thus, results of the following tests must be submitted: 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. 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.


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.

Trials employing working standards, as long as the certification is evidenced, in absence of SQR, shall be admitted. Uniformity of Delivered Dose: Advice on the design of BE studies: Bioequivalence of dermatological topical medicines: Pharmaceutical Equivalence of Nasal Sprays and Aerosols The Pharmaceutical Equivalence consists in verifying if test drug T complies, integrally, with the specifications of the Pharmacopoeia and with the remaining performance tests as described in the Guidance, and if results obtained are equivalent to the results of reference drug R.

Guideline for pharmaceutical equivalence determination and dissolution profile comparison—RDC n. In the continuous process of revising and updating regulatory recommendations, it is essential that international regulatory authorities and organizations share their experiences.