- 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 ...
- ... 3 MED Dosage Form ID 4 MED Routed Dosage Form Medication Description 5 MED Medication Status Code File: RMIGECD1_REF_GEN_THERAP_DESC MED Reference Generic Therapeutic Equivalence Code Description Table Relates the ...
- 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 ...
- ... each of these lists were added to the Reference Packets at each computer terminal. The programmer also unlinked drugs from dosage forms and doses, allowing the research associates to enter ...
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