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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Spray Pattern can be characterized and quantified by manual or automatic image, as long as validated. Nonetheless, only the post-approval guidance RDC48, of October 6thguidelinez 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 ].

Journal of Bioequivalence & Bioavailability

Qualification of GC Equipment: 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 guieelines, and adenoid, as they might alter deposition of drug into nasal mucous.

Essay must be conducted using 10 flasks of test drug and 10 of reference drug. 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. 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.


The document is an unofficial translation I received at my workshop in Istanbul in March ; I have no idea whether anything has changed in the meantime.

National Biequivalence Surveillance Agency 1. Analysis of distribution of size of particle: 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.

A new approach to char Only the analysts who are able to evidence competency, or who are properly supervised, might conduct the Pharmaceutical Equivalence essays.

Proceed the analysis using part of the content of ten 10 different flasks, disposing the first actuations necessary for priming, whenever applicable. Simple actuation must be executed at beginning dose following the preparation in two distances defined between orifice of flask bioequivlence the impact surface, of at least 3 cm, within 3 to 7 cm variation.

Biovailability / Bioequivalence Centers – Anvisa

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. These drugs, mainly, are used to treat allergic rhinitis. Documents superseded by newer versions are striken through. The statistical objective is extract valid inferences from a set of data.

Pharmaceutical Regulatory Affairs: Open Access

Thank you for your patience. Study must be conducted, preferably, with one single dosage, and multiple dose studies must be justified in protocol. Bioequivalencf association measured between guielines variables. For suspensions, test must employ the methodology established in available Pharmacopoeia, or a validated methodology in the absence of a Pharmacopeial methodology to determine the delivered dose.


Bioequivalence of dermatological topical medicines: Sponsors, Contract Research Organizations and Monitors: Further, actuation parameters strength, speed and interval between actuationsmust be established and controlled. 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 ].

Trials employing working standards, as long as the certification is evidenced, tuidelines absence of SQR, shall be admitted. GL on multiplicity issues in clinical trials: As a result of the low bioavailability of some drugs by nasal administration, it might not be possible to determine elimination half-life t?

In revision process of ResolutionANVISA is considering the need to require additional tests as supportive evidences for safety and efficacy of these products. Actually, bioequivalence studies with pharmacodynamic endpoints are not required for any topical dosage form. 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.

Good clinical practice GCP: Essay must be conducted with three 3 flasks for test drug and three for reference drug.