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Related Concept Videos

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

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Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
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Drug Regulation01:25

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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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Pharmacovigilance01:19

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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Drug Nomenclature01:17

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During the development of a new pharmaceutical, the manufacturer initially assigns a code name to the drug. Once approved, the drug receives a United States Adopted Name (USAN)—a generic, nonproprietary designation. Upon being listed in the United States Pharmacopeia, this nonproprietary name becomes the drug's official name. Additionally, the manufacturer assigns a proprietary name or trademark, which serves as the brand name under which the drug is marketed. It is worth noting that...
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High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents HPHC
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Standardised (plain) packaging: the time for implementation has come.

Janet Hoek1, Richard Edwards, Mike Daube A O

  • 1Professor of Marketing, Co-Director ASPIRE2025, University of Otago, Dunedin. janet.hoek@otago.ac.nz.

The New Zealand Medical Journal
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Summary
This summary is machine-generated.

Standardised packaging laws, proven effective in Australia, reduce smoking appeal and consumption. New Zealand should adopt this policy to meet its Smokefree 2025 goal.

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Area of Science:

  • Public Health
  • Health Policy
  • Tobacco Control

Background:

  • Standardised (plain) packaging legislation is being adopted globally.
  • New Zealand's plain packaging legislation is currently stalled.
  • Strong evidence supports the effectiveness of standardised packaging.

Purpose of the Study:

  • To evaluate the impact of standardised packaging on smoking.
  • To inform New Zealand's policy decisions regarding plain packaging.

Main Methods:

  • Analysis of Australian standardised packaging evaluations.
  • Review of tobacco consumption data in Australia.
  • Assessment of the impact on smoking appeal.

Main Results:

  • Australian evaluations show standardised packaging reduces smoking appeal.
  • Tobacco consumption has declined in Australia post-implementation.
  • Evidence strongly supports the efficacy of this tobacco control measure.

Conclusions:

  • The Australian experience provides compelling evidence for standardised packaging.
  • New Zealand should implement plain packaging to support its Smokefree 2025 target.
  • Policy adoption is crucial for reducing smoking rates and appeal.