Drug Development

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

Several factors must be considered when reformulating APIs for pediatric, geriatric, and other specialty patient populations.

Adapting APIs for Specialty Dosage Forms

On Tuesday Nov. 5, 2019, Dr. Meinolf Brackhagen from DuPont Nutrition & Biosciences will discuss the current and future roles of excipient suppliers

Exploring the Role of Excipient Suppliers

Agnes Shanley is senior editor of Pharmaceutical Technology.

Emphasizing the need for senior management to take cGMP compliance seriously, the agency pointed to “improvisational” validation procedures, lack of compliance with written procedures, as well as  inadequate process control, root cause analysis, and corrective and preventive action (CAPA) in its warning letter.

FDA cites repeated, fundamental cGMP issues in its warning letter to Torrent Pharmaceuticals

The companies will collaborate to identify and develop in-vivo genome editing therapeutic candidates for genetic diseases, including hemophilia.

Novo Nordisk, bluebird bio Partner to Develop Genetic Disease Therapeutics

Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development.

Stability Testing for Small-Molecule Clinical Trial Materials

Aloka Srinivasan, PhD, is Principal and Managing Partner, Raaha LLC.

The author provides a direction for identifying genotoxic impurities early in the drug development process, regulating genotoxic impurities at acceptable levels in the API or drug product, and avoiding negative product regulation late in the development and/or marketing process, including expensive recalls. 

Proactive Evaluation of Possible Genotoxic Impurities During the Early Stages of Drug Development

Frank Romanski, PhD is head of Global Marketing, Pharma Solutions, BASF Corp, Florham Park, NJ, frank.romanski@basf.com.

High-throughput platforms can be used to develop tertiary phase diagrams, which can be leveraged to identify the most stable SEDDS formulations and excipients for lipid-based drug delivery systems.

How Excipient Type Influences Self-Emulsifying Drug Delivery

MattÂ Richardson is business development manager at Capsule Delivery Solutions, Lonza Pharma & Biotech.

Nicolas Madit is senior business development manager at Capsule Delivery Solutions, Lonza Pharma & Biotech

Technological advancements can address the formulation and dissolution challenges of HPMC polymers.

Advancements in Encapsulation Technology

john Hammond is Technical & Marketing Manager with Starna Scientific Limited, 52-54 Fowler Road, Hainault Business Park, Hainault, Essex, IG6 3UT, UK

Nancy Lewen is research fellow, CSD Analytical chemistry, Bristol-Myers Squibb.

Emmanuel Akala is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

Anthony Hickey is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients.

Jolyon Mitchell is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

June Liang is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

Timothy Shelbourn is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

Katherine Tyner is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

Eloise Welfare is a members of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

Norbert Maurer is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

Munir Hussain is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

Lawrence Block is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

Myke Scoggins is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

Thomas Tice is a member of the Joint Subcommittee of the United States Pharmacopeia Expert Committees on Dosage Forms, Chemical Analysis, Physical Analysis, and Excipients

In this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.


Perspectives on Quality Attributes of Drug Products Containing Nanomaterials

George Collins is vice president, Vanderbilt Chemicals LLC. 

Katherine Ulman is president, KLU Consulting.

Douglas G. Muse is consultant—Compendial Affairs, Eli Lilly & Co.

Joseph Zeleznik is chair, IPEC-Americas QbD Committee

Priscilla Zawislak is global regulatory affairs advocacy manager, DuPont Nutrition & Biosciences

Elizabeth Tocce is associate application development engineer, Dupont.

R. Christian Moreton, PhD, is vice-president of pharmaceutical sciences at Finnbrit Consulting and a member of Pharmaceutical Technology’s editorial advisory board.

This article seeks to encourage continued dialogue among stakeholders to achieve consensus regarding excipient additives and processing aids.

APIs and Excipients