By Evan B. Siegel
A step by step, built-in process for profitable, FDA-approved mixture drug products
utilizing a confirmed built-in method of mixture drug improvement, this e-book publications you step-by-step via all of the preclinical, medical, and production phases. Written from an FDA regulatory point of view, the e-book not just allows you to deliver a profitable mix drug product to marketplace, it additionally units forth the best and powerful route to FDA approval.
The ebook starts off with an introductory bankruptcy proposing definitions and simple regulatory ideas of mixture items. subsequent, it studies production and controls, preclinical checking out versions, pharmacology, medical checking out, regulatory submissions, FDA studies, and approvals. one of the key issues tested are:
* The pharmacology, protection pharmacology, and toxicology aiding human medical trials of mixture products
* methods to medical trial protocol layout and execution
* Chemical, physicochemical, and analytical facets of producing controls and validation that bring about solid elements for blend products
* Key sponsor/FDA conferences and negotiations crucial for approval and commercialization
Case reviews related to such real blend items as Mylotarg, Herceptin, and HercepTest assist you higher know the way to enforce the author's functional instructions. References on the finish of every bankruptcy provide help to locate additional information on any level of the advance, production and approval processes.
This e-book is perfect for researchers, regulators, teachers, undertaking managers, and managers concerned with the advanced means of mixture product improvement. not just does itoffer a complete advisor to the technical facets of the sphere, it additionally integrates all ofthese technical facets right into a unified, powerful method of aid confirm a winning, authorized product.Content:
Chapter 1 evaluation of mixture items improvement and Regulatory evaluate (pages 1–4): Evan B. Siegel
Chapter 2 specific Regulatory techniques to improvement, overview, and Approval (pages 5–75): James Barquest
Chapter three Nonclinical thoughts for profitable Characterization and improvement of mix Drug items (pages 77–111): Duane B. Lakings
Chapter four medical Pharmacology and medical improvement of mixture items (pages 113–170): Chaline Brown
Chapter five Regulatory method concerns for Chemistry, production, and Controls: An built-in procedure (pages 171–200): Patrick L. DeVillier
Read or Download Development and Approval of Combination Products: A Regulatory Perspective PDF
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Extra info for Development and Approval of Combination Products: A Regulatory Perspective
The stent provides a mechanical scaffold to keep a vessel open. This is a device MOA under the definition. The drug-eluting stent is coated with a drug that is intended to be slowly released from the stent after placement in the vessel to prevent the buildup of new tissue that would reocclude the artery. The pharmacological action of the drug in preventing new tissue buildup is a drug MOA. The PMOA of this product is attributable to the device component’s function of physically maintaining vessel lumen patency.
The regulations therefore describe a mechanism for sponsors to appeal jurisdictional designations. The sponsor may request the product jurisdiction officer to reconsider the decision by filing a written request for reconsideration within 15 days of receipt of the letter of designation. The request for reconsideration should not exceed five pages, and no new information may be included in the request. OCP is required to respond to the appeal in writing within 15 days of its receipt. 42 DETAILED REGULATORY APPROACHES TO DEVELOPMENT, REVIEW, AND APPROVAL In addition to designating the Center that will be assigned primary jurisdiction over the combination product, OCP may indicate in its RFD response that other Centers may collaborate or consult in the review as necessary.
To the outside observer this could make the designation process appear subjective and perhaps inconsistent, particularly when jurisdictional assignments for apparently similar products differ. In response to these types of concerns, the FDA amended its combination product regulations (5) to † † † define “mode of action” (MOA) and “primary mode of action” (PMOA); describe an algorithm to assign combination products to a Center for regulatory oversight when the Agency cannot determine with reasonable certainty which mode of action provides the most important therapeutic action of the combination product; require a sponsor, in its RFD, to base its recommendation of the Center with primary jurisdiction for regulatory oversight of its combination product on the PMOA definition and, if appropriate, the assignment algorithm.