- NLM Digital Collections - Drug literature : a factual survey on "The nature and magnitude of drug literature." : report ...Publication: Washington, D.C. : U.S. G.P.O., 1963... methods, action and uses, toxicity, methods of administration, dosage forms and literature references. The English edition in Spanish (Medica- mentos de ...
- NLM Digital Collections - Questions and answers on biosimilar development and the BPCI ActPublication: Silver Spring, MD : Center for Drug Evaluation and Research, September 2021... that its proposed biosimilar product has the same dosage form as the reference product? .......................... 17 Q.I.19. If a non- ... that its proposed biosimilar product has the same dosage form as the reference product? [Final December 2018] A.I.18. Under ...
- NLM Digital Collections - COVID-19 container closure system and component changes : glass vials and stoppersPublication: [Silver Spring, MD] : Center for Drug Evaluation and Research, March 2021... documents specific to various application types and product dosage forms (see section VII., References). The content in section IV., Common Changes Related ...
- NLM Digital Collections - Manufacturing, supply chain, and drug and biological product inspections during COVID-19 ...Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, May 17, 2021... up and postapproval change guidance documents for specific dosage forms (see section V. References). Should circumstances resulting from the COVID-19 pandemic ...
- NLM Digital Collections - E6(R2) good clinical practice : integrated addendum to ICH E6(R1)Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018... absolute, where possible, and/or relative) using a reference dosage form. - Population subgroups (e.g., gender, age, and impaired ...
- NLM Digital Collections - Rx Price Watch report : retail prices for widely used brand name drugs increase considerably ....Publication: Washington, D.C. : AARP Public Policy Institute, c2011... have the same active ingredient, route of administration, dosage form, strength, and proposed labeling as the reference-listed (brand name) drug. The generic drug manufacturer ...
- NLM Digital Collections - Generic drug development : stakeholders’ views of risk evaluation and mitigation strategies ...Publication: Washington, DC : United States Government Accountability Office, October 2019... active ingredient(s), conditions of use, route of administration, dosage form, strength, and labeling (with certain permissible differences) and (2) bioequivalent to the reference listed drug, meaning it generally delivers the same ...
- NLM Digital Collections - Chemistry, manufacturing, and control (CMC) information for human gene therapy ...Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020... includes a list of all components of the dosage form, their amounts on a per-batch basis, and a reference to their quality standards. c. Description of Manufacturing ...
- NLM Digital Collections - Prescription drug spending by Medicare beneficiaries in institutional and residential ...Publication: Washington, D.C. : Office of Disability, Aging, and Long-Term Care Policy, Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, [2007]... are: INPUT and FINAL PRICE FILE CMS CROSS-REFERENCE FILE ROLLUP FILES (DOSAGE FORM, STRENGTH, and PACKAGE SIZE) INPUT DRUG FILE (aka ... the input drug File (e.g., CMS x-reference File). The resulting FINAL PRICE ... Dosage forms, Strengths, and Packages Sizes. These three individual roll- ...
- NLM Digital Collections - The "deemed to be a license" provision of the BPCI Act : questions and answersPublication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2020... has the same active ingredient(s), conditions of use, dosage form, route of administration, strength, and (with certain permissible differences) labeling as the reference listed drug (section 505(j)(2)(A) of ...
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