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Research article

First published 1993-12

Regulatory Concerns for the Chemistry,Manufacturing,and Controls of Oligonucleotide Therapeutics for Use in Clinical Studies

Rao V. B. Kambhampati, Yuan-Yuan Chiu, Chi Wan Chen [...]

Nucleic Acid Therapeutics

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Research article

First published 2022-04

Individualized Antisense Oligonucleotide Therapies: How to Approach the Challenge of Manufacturing These Oligos from a Chemistry,Manufacturing,and Control-Regulatory Standpoint

Marc M. Lemaitre

Nucleic Acid Therapeutics

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Other

First published 1998-4

Organization and Responsibilities of the Chemistry,Manufacturing,and Controls Function within Regulatory Affairs: A Survey of 17 Companies

Samuel T. Barnett, Roger W. Croswell, Anthony C. Cartwright [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2003-6

Comparability Protocols: Chemistry,Manufacturing and Controls Information

Jim Drennen, Carl Anderson

NIR news

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Research article

First published 1997-1

An Integrated Approach to the Preparation of Global CMC Dossiers

Peter C. Karlton, David Johnston

Therapeutic Innovation & Regulatory Science

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Other

First published 2002-7

Recommendations to the Food and Drug Administration: Metered Dose Inhaler Tests and Methods in the Chemistry,Manufacturing,and Controls Draft Guidances for Metered Dose Inhalers and Dry Powder Inhalers

Lee M. Nagao

Therapeutic Innovation & Regulatory Science

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Article commentary

First published 2019-2

Thoughts on Chemistry,Manufacturing,and Control of Cell Therapy Products for Clinical Application

Wei Wei, Jianhui Luo

Human Gene Therapy

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Editorial

First published 2022-04

Oligonucleotides and N = 1 Therapeutics: From the Patient Perspective to Chemistry,Manufacturing,and Control

Tim Yu, Daniel O'reilly

Nucleic Acid Therapeutics

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Other

First published 2022-3

Innovative medicine development

Valerie Pimpaneau, Emmanuelle Voisin

Technology and Health Care

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Research article

First published 2005-4

Draft Guidance for Industry. ANDAs: Pharmaceutical Solid Polymorphism. Chemistry,Manufacturing and Controls Information

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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