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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The use of surfactants is prohibited, and enzymes are allowed for gelatin capsules only. For solutions, must be determined the relative mass of bioequivaldnce actuation per flask by differences in weight before and after actuation. Follow official methodology and specification for each active ingredient; 3.

Determination of nominal volume in liquid products with multiple doses is executed by content weight.

Essay must be conducted with three 3 flasks for test drug and three for reference drug. Description must follow Brazilian Pharmacopeia; 3.

The results obtained for test drug Tshall be compared to the results of the reference drug Rthus, determining existence or lack of Pharmaceutical Equivalence. National Health Surveillance Agency. 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.

The weight of each flask must be calculated and must fall within two standard deviations.

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In the absence of Pharmacopeial method, the study must be undertaking using a method that has been validated by test drug product manufacturer and must be co-validated by the study executer lab, with the complementation of essays described in General Methods of current Brazilian Pharmacopoeia. Considering that drugs administered by nasal route reach low plasmatic concentrations, doses administered can be equal, or higher, than therapeutic doses, as long as safety of volunteers is warranted.


Training Workshop on P We would like to comment on an interesting review article on the similarities and differences among international guidelines for determining bioequivalence BE of generic drug products 1. Because the legal framework of the Brazilian Health Surveillance Agency ANVISA is available only in Portuguese, it might have been difficult to search information properly or to identify updated guidelines.

Qualification of GC Equipment: The batches must be submitted in parallel to the essays established in the monograph of the Brazilian Pharmacopoeia or remaining official publications, as per the current Resolutions and the referred Guidance.

As ofr result of the low bioavailability of some drugs by nasal administration, it might not be possible to determine elimination half-life t? To conduct the essay, is recommended the compliance with the equipment’s manufacturing instructions regarding to obscuration and transmittance percent.

Actuations must be conducted in accordance with procedure described in label. National Center for Biotechnology InformationU.

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

In the continuous process of revising and updating regulatory recommendations, it is essential that international regulatory authorities and organizations share their experiences. Analysis of acidity or alkalinity of a solution. International guidelines for bioequivalence of systemically available orally administered generic drug products: To warrant reproducibility of collection of samples, the employment of mechanical actuation methods is recommended.

Acceptance of clinical trials conducted in third countries, for evaluation in MAAs: Gelfusoand Tais Gratieri.

Before beginning clinical phase, volunteers must receive training regarding administration of drugs. Essay must be conducted using 10 flasks of test drug and 10 of reference drug.

Journal of Bioequivalence & Bioavailability

GL on multiplicity issues in clinical trials: Samples, standard reagents and reference materials must be properly stored to warrant their integrity and traceability. Analysis follows the methods of Brazilian Pharmacopeia using the amount of flasks and the specification in accordance with stated volume. Parenteral aqueous solutions do not have to be buidelines with the same inactive ingredients as their reference formulations. Results must be evaluated by the mean of three tested unities and it must not be smaller than the labeled number of doses.


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. For drugs that are administered by nasal route, bioavailability is related to a series of bioesuivalence 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 guiddelines, within 3 to 7 angisa variation.

Further, actuation parameters strength, speed and interval between actuationsmust be established and controlled. This Resolution shall be in effect on the date of its publication. Guideline for pilot batch notification—IN n. Thank you for your patience. For suspensions, the dose must be released in a proper recipient, which might allow the due transfer of the content.

Pharmaceutical Equivalence of Nasal Sprays and Aerosols 3. Uniformity of Delivered Dose: