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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
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Delayed-release drug delivery systems are specialized pharmaceutical formulations designed to postpone the release of active compounds until the drug reaches a specific region of the gastrointestinal (GI) tract, typically the intestine. These systems are essential for drugs that may cause gastric irritation, are unstable in acidic environments, or need to exert therapeutic effects locally in the intestinal or colonic regions.The core feature of delayed-release systems is the use of enteric...
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Diarrhea-predominant irritable bowel syndrome (IBS-D) is a subtype of IBS characterized primarily by frequent, loose, or watery stools, abdominal pain, and abdominal discomfort. Therapeutic approaches to managing IBS-D include dietary changes, stress management techniques, and pharmaceutical interventions.
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Site-targeted drug delivery systems enhance therapeutic efficacy while minimizing systemic toxicity and treatment costs. Unlike conventional methods, these systems ensure precise drug delivery, improving bioavailability and reducing side effects. Targeted drug delivery is classified into three levels. First-order targeting directs drugs to the capillary beds of specific organs or tissues. Second-order targets specific cell types, such as tumor cells, using receptor-mediated interactions.
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Delamanid: first global approval.

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Delamanid, a novel drug for multidrug-resistant tuberculosis (MDR-TB), has gained its first global approval in the EU. This milestone marks significant progress in treating this severe form of tuberculosis.

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Area of Science:

  • Pharmaceutical development
  • Infectious diseases
  • Drug discovery

Background:

  • Multidrug-resistant tuberculosis (MDR-TB) poses a significant global health challenge.
  • Existing treatments for MDR-TB are limited and often associated with severe side effects.
  • Delamanid represents a new class of compounds for addressing MDR-TB.

Purpose of the Study:

  • To summarize the key milestones in the development of delamanid.
  • To highlight the regulatory journey leading to the first approval of delamanid for MDR-TB.

Main Methods:

  • Review of preclinical and clinical development data for delamanid.
  • Analysis of regulatory submissions and approvals in key markets.
  • Summary of the drug's mechanism of action and therapeutic potential.

Main Results:

  • Delamanid, a nitro-dihydro-imidazooxazole derivative, has been developed by Otsuka Pharmaceutical.
  • Received first global marketing approval in the European Union for MDR-TB treatment.
  • Granted orphan drug status in the EU and Japan, indicating its potential for rare diseases.

Conclusions:

  • Delamanid's approval signifies a crucial advancement in the therapeutic options for MDR-TB.
  • The drug's development journey highlights successful pharmaceutical innovation in combating resistant pathogens.
  • Further regulatory reviews are ongoing in other key markets, including Japan.