The current BSC guidance issued by the FDA allows for biowaivers based on conservative criteria. Possible new criteria and class boundaries are proposed for additional biowaivers based on the underlying physiology of the gastrointestinal tract. The proposed changes in new class boundaries for solubility and permeability are as follows: 1. Narrow the required solubility pH range from 1.0-7.5 to 1.0-6.8. 2. Reduce the high permeability requirement from 90% to 85%. The following new criterion and potential biowaiver extension require more research: 1. Define a new intermediate permeability class boundary. 2. Allow biowaivers for highly soluble and intermediately permeable drugs in IR solid oral dosage forms with no less than 85% dissolved in 15 min in all physiologically relevant dissolution media, provided these IR products contain only known excipients that do not affect the oral drug absorption. The following areas require more extensive research: 1. Increase the dose volume for solubility classification to 500 mL. 2. Include bile salt in the solubility measurement. 3. Use the intrinsic dissolution method for solubility classification. 4. Define an intermediate solubility class for BCS Class II drugs. 5. Include surfactants in in vitro dissolution testing.

/pdf/biopharmaceutics-classification-system-the-scientific-basis-1vvr50wd2i.pdf

Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions

Contributors Jean-Marc Aiache, Nobuo Aoyagi, Dennis Bashaw, Cynthia Brown, William Brown, Diane Burgess, John Crison, Patrick DeLuca, Ruzica Djerki, Jennifer Dressman, Thomas Foster, Kirsti Gjellan, Vivian Gray, Ajaz Hussain, Tom Ingallinera, James Klancke, Johannes Kraemer, Henning Kristensen, Kofi Kumi, Christian Leuner, Jobst Limberg, Petra Loos, Lenny Margulis, Patrick Marroum, Helga Moeller, Bernd Mueller, Martin Mueller-Zsigmondy, Ngozi Okafo, Larry Ouderkirk, Shravan Parsi, Saeed Qureshi, Joseph Robinson, Vinod Shah, Martin Siewert, Ramana Uppoor, and Roger Williams. Aventis, Frankfurt, Germany JW Goethe University, Frankfurt, Germany Eli Lilly and Company, Indianapolis, IN Office of Pharmaceutical Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD Universite d'Auvergne, Clermont-Ferrand Cedex, France National Institute of Health Sciences, Division of Drugs, Tokyo, Japan US Pharmacopeia, Rockville, MD University of Connecticut, Storrs Mansfield, CT Pfizer, Inc, La Jolla, CA University of Kentucky, Lexington, KY Novartis Pharma, Basel, Switzerland AstraZeneca, Sodertalje, Sweden V.A. Gray Consulting, Inc, Hockessin, DE AAI International, Charleston, SC CIMA Laboratories, Inc, Minneapolis, MN Laboratory and Quality Services, Eschborn, Germany University of Copenhagen, Denmark Bundesinstitut fur Arzneimittel, Bonn, Germany Aventis Pharmaceuticals, Bridgewater, NJ Pfizer, Groton, CT Zentrallaboratorium Deutscher Apotheker, Eschborn, Germany Kiel University, Kiel, Germany Alza Corporation, Mountain View, CA DPT Laboratories, Ltd, San Antonio, TX Health Protection Branch, Ottawa, Canada University of Wisconsin, WI

/pdf/fip-aaps-guidelines-to-dissolution-in-vitro-release-testing-2cp52c25iq.pdf

FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms

In 2003, the FIP Dissolution Working group published a position paper on dissolution/drug release testing for special/novel dosage forms that represented the scientific opinions of many experts in the field at that time (1). The position paper has supported activities, programs, and decisions in the scientific, technical, and regulatory community. Due to the rapid evolution of new practices and techniques for in vitro testing, the FIP Special Interest Group (SIG) on Dissolution/Drug Release decided to revise the previous paper and added proposals for further harmonization of in vitro release testing practices for different pharmaceutical dosage forms. This article represents the current updates to the previously published paper. This revision has been aligned to coincide with the USP taxonomy including route of administration, intended site of drug release, and dosage form. The revised paper includes information from current literature, expert discussions, and presentations from recent workshops (2,3). The authors acknowledge and expect further updates to be made as additional progress is made in the relevant areas. Thus, comments and additional contributions are welcome and may be considered for the next revision of the position paper.

/pdf/fip-aaps-joint-workshop-report-dissolution-in-vitro-release-42h8x4d1lz.pdf

FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms

A pharmaceutical composition useful for treating hypogonadism is disclosed. The composition comprises an androgenic or anabolic steroid, a C1-C4 alcohol, a penetration enhancer such as isopropyl myristate, and water. Also disclosed is a method for treating hypogonadism utilizing the composition.

Pharmaceutical composition and method for treating hypogonadism

The objective of this article is to compare and contrast the international expectations associated with the model-independent similarity factor approach to comparing dissolution profiles. This comparison highlights globally divergent regulatory requirements to meet local dissolution similarity requirements. In effect, experiments customized to meet the current international regulatory expectations for dissolution and drug release unnecessarily increase manufacturing costs, hinder science and risk-based approaches, increase collective regulatory burden, reduce continuous improvement and innovation, and potentially delay patient access to urgently needed medication. Comparative assessment of regulatory differences in applying dissolution to demonstrate product similarity is crucial to reduce non-scientifically justified experiments and foster collaborative harmonization among global regulatory health authorities and the pharmaceutical industry.

/pdf/erratum-to-dissolution-similarity-requirements-how-similar-2beccfa3lh.pdf

Erratum to: Dissolution Similarity Requirements: How Similar or Dissimilar Are the Global Regulatory Expectations?

The new FDA Guidance for Industry BA and BE Studies for Orally Administered Drug Products - General Considerations and Average, Population, and Individual Approaches to Establishing Bioequivalence imply significant changes in the areas of enrollment, cost, ethics, time, entry, validation applications (EVAs), and statistical and pharmacokinetic methods. The changes from three-period to two-period design for food effect studies, the elimination of most steady state studies, and the analyses of only the active moiety or ingredient are welcome. However, if the current guidances are adopted, additional time will be needed for participants, and more participants will be needed, resulting in higher costs to drug developers. The PK parameters needed to assess BE and the need for replicate designs for drugs with long t 1/2 are still unclear. Finally, the advantages of the aggregate property of the FDA metric versus the disaggregate criteria are challenged, and four bioeauivalence criteria are proposed.

A contract research organization's response to the new FDA guidances for bioequivalence/bioavailability studies for orally administered drug products.

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A contract research organization's response to the new FDA guidances for bioequivalence/bioavailability studies for orally administered drug products.