Bibliographic record
Abstract
The established role of pharmaceutical products in the current health care landscape combined with increasing reports of serious and often fatal toxicity associated with these products have led to growing calls for reform of drug regulation. The growing public-private partnerships in research and drug development and their impact on the regulatory control of pharmaceuticals are in this context the target of much criticism. Ensuring the safety and efficacy of pharmaceuticals in continuously changing health care, research and economic environments has been an increasingly significant challenge for public health. In this chapter, we seek to give a critical overview of various components of this important public health topic. We review the general regulatory framework in which drugs are approved in Canada. As part of this discussion, we outline the steps required to be taken by pharmaceutical manufacturers to obtain regulatory approval and trace the changing roles of public and private actors in the drug development cycle, using several recent controversies related to pharmaceutical products to illustrate this point. We also describe how drug regulation in Canada is connected to other domestic and international regulatory regimes that relate to various aspects of pharmaceutical product development, medical research and health care. Finally, we review several important new developments involving federal policies that underpin pharmaceutical regulation in Canada, with particular emphasis on the increasing partnership between Canadian policy-makers and corporate interests. Indeed, the larger regulatory landscape surrounding pharmaceuticals is undergoing significant change at this time and it is important to situate this development in the context of the current regulatory regime. In order to appreciate the nature of these policy changes, and to facilitate a critical assessment of their potential impact, we will first give a brief overview of the history of drug regulation. Indeed, the historical context helps to understand the rationale behind drug regulation and to appreciate the important role for regulatory oversight in the context of drug regulation.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.010 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.003 | 0.006 |
| Science and technology studies | 0.010 | 0.007 |
| Scholarly communication | 0.009 | 0.002 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.005 | 0.005 |
| Insufficient payload (model declined to judge) | 0.012 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".