Biowaiver

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BIO WAIVERS: 

BIO WAIVERS Mr. Nitin Kadam

Will Talk On….: 

Will Talk On…. Provision for waivers of in vivo BA/BE studies Biowaiver extensions for CLASS II & III drugs References

PowerPoint Presentation: 

Provision for waivers of in vivo BA/BE studies (Biowaiver) under certain conditions is provided in 21 CFR 320.22.

Requirement of Bio waiver….: 

Requirement of Bio waiver…. A. For certain drug products, the in vivo bioavailability or bioequivalence of the drug product may be self-evident.

A.a.: 

A.a . The drug product: Is a potential solution intended solely for administration by injection, or an ophthalmic or otic solution; and Contains the same active and inactive ingredients in the same concentration as a drug product that is the subject of an approved full new drug application .

A.b.: 

The drug product: Is administered by inhalation as a gas, e.g., a medicinal or an inhalation anesthetic; and Contains an active ingredient in the same dosage form as a drug product that is the subject of an approved full new drug application. A.b .

A.c: 

A.c The drug product: Is a solution for application to the skin, an oral solution, elixir, syrup, tincture, or similar other solubilized form . Contains an active drug ingredient in the same concentration and dosage form as a drug product that is the subject of an approved full new drug application; and Contains no inactive ingredient or other change in formulation from the drug product that is the subject of the approved full new drug application that may significantly affect absorption of the active drug ingredient or active moiety.

B.: 

B. Solid oral dosage form (other than an enteric coated or controlled release dosage form) of a drug product determined to be effective for at least one indication in a Drug Efficacy Study Implementation notice or which is identical, related, or similar to such a drug product under § 310.6 of this chapter unless FDA has evaluated the drug product under the criteria set forth in § 320.32, included the drug product in the Approved Drug Products with Therapeutic Equivalence Evaluations List, and rated the drug product as having a known or potential bioequivalence problem.

C.: 

C. For certain drug products, bioavailability or bioequivalence may be demonstrated by evidence obtained in vitro in lieu of in vivo data

C.1.: 

C.1. The drug product is in the same dosage form, but in a different strength , and is proportionally similar in its active and inactive ingredients to another drug product for which the same manufacturer has obtained approval

C.2.: 

C.2. The drug product is shown to meet an in vitro test that has been correlated with in vivo data

C.2.: 

The drug product is a reformulated product that is identical, except for a different color, flavor, or preservative that could not affect the bioavailability of the reformulated product , to another drug product for which the same manufacturer has obtained approval and the following conditions are met: C.2.

PowerPoint Presentation: 

GUIDANCE FOR INDUSTRY (Covered last year……….)

Biowaiver Extension Potential for Class II Drugs:-: 

Biowaiver Extension Potential for Class II Drugs:- These are typically poorly soluble weak acids with pKa values of ≤4.5 and intrinsic solubility (solubility of the un–ionized form) is of ≥ 0.01 mg/ ml. At pH values typical of the fasted state in the jejunum (about 6.5), these drugs will have solubility of ≥ 1 mg/ ml, resulting in fast and reliable dissolution of the drug . Currently these drugs are classified as class II drugs because they are poorly soluble at gastric pH in which pH much less than pKa .

Biowaiver Extension Potential for Class III Drugs: 

Biowaiver Extension Potential for Class III Drugs Scientific rationale behind suggesting Biowaiver for Class III drugs is that the absorption of class III drugs is limited by its permeability and less dependent upon its formulation and its bioavailability may be determined by its in vivo permeability pattern. If the dissolution of class III products is rapid under all physiological pH conditions, it can be expected that they will behave like an oral solution in vivo . BE studies are generally waived off oral solution drug products because the release of the drug from an oral solution is immediate.

No Biowaiver for….: 

No Biowaiver for…. Locally applied, systemically acting products Non-oral immediate release forms with systemic action Modified release products Transdermal products

References…: 

References… http://ikev.org/haber/bioav/Barends_Istanbul%2004-1_korr.pdf http://www.fda.gov/cder/Guidance/3618fnl.pdf http://www.absorption.com/site/Services/BCS.aspx http://ikev.org/haber/bioav/BA-BE%20Intro-01-30-color.pdf http://medicine.iupui.edu/clinical/F813_spring2006/S_ClinicalPKF813Lecture1709March2006BioavailabilityandBioequivalencerevised.pdf http://www.sfbci.com/SFBC/upload/sfbc/Generateur/LeonShargel.pdf WHO document QAS/04.093 Pharmaceutical process scale- up edited by Michael Levin, Marcel Dekker .inc New York, page: 447-468,551-564. United state of pharmacopoeia