Biomedical subjects

Eric Sheinin

Publications and source records attributed to Eric Sheinin.

3 recordsLinked to original sources

PubMed2005

Equivalence studies for complex active ingredients and dosage forms.

This article examines the United States Pharmacopeia (USP) and its role in assessing the equivalence and inequivalence of biological and biotechnological drug substances and products-a role USP has played since its founding in 1820. A public monograph in the United States Pharmacopeia-National Formulary helps practitioners and other interested parties understand how an article's strength, quality, and purity should be controlled. Such a monograph is a standard to which all manufactured ingredients and products should conform, and it is a starting point for subsequent-entry manufacturers, recognizing that substantial additional one-time characterization studies may be needed to document equivalence. Review of these studies is the province of the regulatory agency, but compendial tests can provide clarity and guidance in the process.

Biotechnology↗

PubMed2005

Oral dosage form performance tests: new dissolution approaches.

The performance test is one of a series of tests that compose the specification in a United States Pharmacopeia (USP) dosage form monograph. For an orally administered, nonsolution dosage form, it is usually satisfied by either a dissolution or disintegration procedure. Dissolution acceptance criteria are usually set in private negotiations between an applicant and a regulatory agency. With information about this private agreement and other information provided in a sponsor's Request for Revision to USP, the USP's Council of Experts elaborates a public dosage form monograph. Based on the relationship between the regulatory decisions and the Request for Revision, the USP dissolution procedure links to a regulatory judgment about bioavailability and bioequivalence and, ultimately, to a judgment about safety and efficacy. The current dissolution procedure and acceptance criteria are perceived as having worked well over the years and are generally accepted. This article discusses new approaches that merit consideration. These approaches focus on a) explicit use of hypothesis testing, b) use of parametric tolerance intervals, c) improved ways to set dissolution acceptance criteria, and d) a more flexible protocol to assess conformity. Application of the proposed approaches may better assess, manage, and communicate both manufacturer and consumer risk for dissolution testing.

Administration, Oral↗

PubMed2002

Chemistry, manufacturing, and controls information in NDAs and ANDAs, supplements, annual reports, and other regulatory filings.

Advice to the pharmaceutical industry regarding the chemistry, manufacturing, and controls and microbiology (sterility assurance) information to be included in regulatory submissions to the Center for Drug Evaluation and Research (CDER) can be found in the pertinent statutes, regulations, and guidances. The primary statute is the Federal Food, Drug and Cosmetic Act (the Act); applicable regulations appear in 21 CFR 312 and 314. Neither the Act nor the regulations provide sufficient detail on the information that should be included in these submissions. Over the past 14 years CDER has issued a series of guidelines and guidances that provide specific detail related to the recommended filing mechanisms and information that CDER expects applicants to provide. Some of these guidances are applicable to original submissions and some are applicable to post-approval changes. This article will provide an overview of The Act, the pertinent regulations, and the pre- and post-approval guidances.

Annual Reports as Topic↗