Advancing Product Quality: a Summary of the Second FDA/PQRI Conference

Yu, Lawrence X.; Akseli, Ilgaz; Allen, Barbara; Amidon, Gregory E.; Bizjak, Tara Gooen; Boam, Ashley B.; Caulk, Margaret; Doleski, David; Famulare, Joseph; Fisher, Adam C.; Furness, Scott; Hasselbalch, Brian; Havel, Henry A.; Hoag, Stephen W.; Iser, Robert; Johnson, Bruce D.; Ju, Robert J.; Katz, Paula S.; Lacaná, Emanuela; Lee, Sau L.; Lostritto, Richard T.; McNally, Grace; Mehta, Mehul; Mohan, Ganapathy; Nasr, Moheb; Nosal, Roger; Oates, Mary; O’Connor, Thomas; Polli, Jim; Raju, G.; Ramanadham, Mahesh; Randazzo, Giuseppe; Rosencrance, Susan; Selen, Arzu; Seo, Paul; Shah, Vinod P.; Sood, Ramesh K.; Thien, Michael P.; Tong, Tony W.; Trout, Bernhardt L.; Tyner, Katherine M.; Vaithiyalingam, Siva; VanTrieste, Martin; Walsh, Fionnuala; Wesdyk, Russell; Woodcock, Janet; Wu, Geoffrey; Wu, Lianjun; Yu, Lisa; Zezza, Diane

doi:10.1208/s12248-016-9874-5

Cited by 18 publications

(4 citation statements)

References 14 publications

(11 reference statements)

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“…All agencies offer early scientific advice procedures for product developer in order to guide them through the approval/authorisation process and they preconize “case‐by‐case” approach to address nano‐specific properties of the product. Furthermore, a number of initiatives were launched within the regulatory agencies to advance the challenges linked to the regulation of nanomedicines (Bartlett et al, ; Yu et al, ). In some countries like the USA, Japan, and in the European Union, some initial guidance documents were released to help product developer in the evaluation of the nanotechnology based products searching for the regulatory approval (Table ).…”

Section: Discussionmentioning

confidence: 99%

Identification of regulatory needs for nanomedicines

Bremer‐Hoffmann

Halamoda-Kenzaoui

Borgos

2018

J of Interdiscip Nanomed

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The application of nanotechnology in health care is widely accepted as a potential driver of biomedical innovation. By exploiting their unique physicochemical properties, nanomedicines can monitor, repair, and control biological systems in order to address diseases for which currently no or only insufficient diagnostic and therapeutic tools are available. Nevertheless, the opportunities of nanotechnologies in the health sector are accompanied by challenges in the regulation of these products. Sufficient knowledge on their quality, safety, and efficacy must be gained and standardised methods must be made available to support the regulatory decision making and allow a smooth translation towards clinical applications. We have conducted a survey among regulatory authorities with the aim to obtain a general overview on the status and regulatory needs of nanomedicines and to indicate some trends on future requirements. The outcome has demonstrated strong regional differences in the regulation of nanomedicines and confirmed the need for the harmonisation of information requirements on nano‐specific properties. In addition, a number of critical physicochemical properties that have already been proposed in the scientific literature were verified in the survey as relevant for regulatory decision making. Finally, the survey has demonstrated an interest of regulatory agencies in an independent nanomedicine characterisation facility that can support regulators in the evaluation of these systems and at the same time assess the performance of existing and new test methods for their application to the field of nanomedicine.

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Section: Discussionmentioning

confidence: 99%

Identification of regulatory needs for nanomedicines

Bremer‐Hoffmann

Halamoda-Kenzaoui

Borgos

2018

J of Interdiscip Nanomed

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“…The Product Quality Research Institute (PQRI) and the National Institute for Pharmaceutical Technology and Education (NIPTE) are supporting efforts to promote commercial‐scale product quality and efficient manufacturing. PQRI addresses a wide range of manufacturing topics, including life‐cycle management to detect drifts in manufacturing process and approaches to shelf‐life estimation of pharmaceutical products . Through their product‐quality research, PQRI have provided evidence‐based recommendations to the FDA regarding manufacturing standards, which have informed numerous regulatory guidances for a broad range of topics ( Table ).…”

Section: Ppp Deliverables and The Critical Path Opportunities Listmentioning

confidence: 99%

“…PQRI addresses a wide range of manufacturing topics, including life-cycle management to detect drifts in manufacturing process and approaches to shelf-life estimation of pharmaceutical products. 61,62 Through their product-quality research, PQRI have provided evidence-based recommendations to the FDA regarding manufacturing standards, which have informed numerous regulatory guidances for a broad range of topics ( Table 3).…”

Section: Topic 4: Moving Manufacturing Into the 21 St Centurymentioning

confidence: 99%

The Role of Public–Private Partnerships in Catalyzing the Critical Path

Maxfield

Buckman-Garner

Parekh

2017

Clinical Translational Sci

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“…6 Despite the great potential of botanical drugs, detailed knowledge of their compositions and biological activities is often lacking, as is evidence for their safety and therapeutic efficacy. In addition, as naturally occurring mixtures for which influencing factors (e.g., agricultural practice and manufacturing process) often are not well-defined and controlled, 7,8 these drugs may exhibit considerable variability from raw materials to final products. Therefore, quality control is highly critical for ensuring the safety, efficacy, and consistency of botanical drugs.…”

mentioning

confidence: 99%

Mass Spectrometry-Sensitive Probes Coupled with Direct Analysis in Real Time for Simultaneous Sensing of Chemical and Biological Properties of Botanical Drugs

Wang

Cheng

2019

Anal. Chem.

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The development of botanical materials as therapeutic agents involves the meticulous assessment of safety, efficacy, and quality. Compared with small-molecule drugs, quality control of botanical drugs confronts with more significant challenges due to their inherent complexity. Current quality control methods for botanical drugs, either prevailing chemical tests or emerging biological assays, are not able to meet recent demands of multiplexing, sensitivity, and speed.Here, we propose an on-demand strategy based on a direct analysis in real time-mass spectrometry (DART-MS) platform, which is capable of simultaneously analyzing multiple constituents and bioactivities of botanical drugs. Notably, the bioactivities are assessed by a multiple-enzyme assay that adopts cleavable mass spectrometry probes as enzymatic substrates: these probes labeled with a piperazine tag make possible sensitive, multiplexed, and quantitative enzyme activity measurements. The concept is successfully demonstrated via a case study of Danshen (Salvia miltiorrhiza) Injection where simultaneous detection of 34 constituents and inhibitory activities on two target enzymes can be achieved in just minutes. This proof-of-concept application also gives evidence that combining MSsensitive probes with DART-MS can provide an environmentally friendly, highly sensitive analytical approach for botanical quality control.

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Advancing Product Quality: a Summary of the Second FDA/PQRI Conference

Cited by 18 publications

References 14 publications

Identification of regulatory needs for nanomedicines

Identification of regulatory needs for nanomedicines

The Role of Public–Private Partnerships in Catalyzing the Critical Path

Mass Spectrometry-Sensitive Probes Coupled with Direct Analysis in Real Time for Simultaneous Sensing of Chemical and Biological Properties of Botanical Drugs

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