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http://www.authorstream.com/Presentation/aSGuest34145-292047-regulatory-consideration-control-drug-pawan-education-ppt-powerpoint/
Dec 15, 2009 · Rationale of Controlled –Drug Delivery: Basic rationale for controlled drug delivery is to alter the pharmacokinetic and pharmacodynamics of pharmacologically active moieties Primary objectives of controlled drug delivery are to ensure safety and to improve efficiency of drugs as well as patient compliance.
https://www.nibib.nih.gov/science-education/science-topics/drug-delivery-systems-getting-drugs-their-targets-controlled-manner
Drug delivery systems are engineered technologies for the targeted delivery and/or controlled release of therapeutic agents. Drugs have long been used to improve health and extend lives. The practice of drug delivery has changed dramatically in the past few decades and even greater changes are anticipated in the near future.
https://www.researchgate.net/publication/299746892_Regulatory_Considerations_for_Controlled_Release_Parenteral_Drug_Products
Abstract Effective treatment of diseases at the molecular level is possible by directing the drug substance (micromolecular, protein or peptide drugs, DNA, oligonucleotides, siRNA) with the aid of ...Author: Mei-Ling Chen
https://www.tandfonline.com/doi/abs/10.3109/03639048309044700
May 25, 2004 · Regulatory Considerations in Transdermal Controlled Medication Bernard E. Cabana Division of Biopharmaceutics, Food and Drug Administration, Bureau of Drugs…Author: Bernard E. Cabana
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6233305/
The controller determines the level of therapy delivery (eg, drug infusion rate). In both open- and closed-loop control of drug delivery, the quality and fidelity of the PK/PD model plays a central role in the device performance. For example, in open-loop infusion, the PK model may be used to estimate the drug target site concentration.Author: Bahram Parvinian, Christopher Scully, Hanniebey Wiyor, Allison Kumar, Sandy Weininger
https://www.meddeviceonline.com/doc/a-primer-on-investigational-drug-delivery-device-regulatory-requirements-0001
Nov 16, 2015 · A Primer On Investigational Drug/Delivery Device Regulatory Requirements By David Amor , MSBE, CQA, Medgineering The device part of a drug/ delivery system submissions needs to comply to the device requirements for investigational devices – with a few other common sense considerations.
https://www.researchgate.net/profile/Gary_Novack/publication/24023413_Ophthalmic_Drug_Delivery_Development_and_Regulatory_Considerations/links/540749340cf2c48563b2a017/Ophthalmic-Drug-Delivery-Development-and-Regulatory-Considerations.pdf
There is a renewed interest in ophthalmic drug delivery ... decreased pulsatile delivery, controlled delivery, and more ... Development and Regulatory Considerations GD Novack1 1PharmaLogic ...
http://www.pharmtech.com/regulatory-considerations-controlled-correspondence-related-generic-drug-chemistry
Sep 01, 2015 · Controlled correspondence is defined as “a correspondence submitted to the agency, by or on behalf of a generic drug manufacturer or related industry, requesting information on a specific element of generic drug product development” (1).
https://www.sciencedirect.com/book/9780444829924/controlled-release-veterinary-drug-delivery
Controlled Release Veterinary Drug Delivery comprises chapters that provide workers in the field (and those interested in this area) with information on the design, development and assessment of a variety of CRVDDS. The book contains chapters that describe the relevant animal physiological and anatomical considerations alongside descriptions of current and emerging controlled release delivery systems for a variety of routes for drug delivery…
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3438887/
Polymers for Drug Delivery Systems. ... Pharmacological Considerations in Drug Delivery. ... Since the advent of controlled release polymer drug delivery systems (DDS), the polymer therapeutics field has exploded as the focus has shifted toward strategies that facilitate targeted release, especially for anticancer drugs, which often have severe ...Author: William B. Liechty, David R. Kryscio, Brandon V. Slaughter, Nicholas A. Peppas
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