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Related Concept Videos

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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Production of Pharmaceuticals01:30

Production of Pharmaceuticals

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Industrial insulin production uses genetically engineered E. coli expressing a proinsulin gene controlled by a tryptophan promoter and containing a methionine linker for later cleavage. The cells also carry ampicillin resistance for selective growth. Seed cultures are stored at −80 °C and production begins by thawing a small amount to inoculate starter cultures, which are progressively scaled to a 50,000-L bioreactor. In the bioreactor, E. coli grow in nutrient-rich media under...
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Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

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As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
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FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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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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Drug Nomenclature01:17

Drug Nomenclature

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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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Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

345
Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules
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Patenting pharmaceuticals in China.

Weiwei Han1, Juhua Luo1

  • 1CCPIT Patent & Trademark Law Office, 10/F, Ocean Plaza, 158 Fuxingmennei Street, Beijing 100031, China.

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|June 25, 2016
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Summary
This summary is machine-generated.

China's evolving pharmaceutical market demands robust patent protection. This article details patent prosecution and enforcement, including upcoming legal amendments, crucial for commercializing drugs in China.

Keywords:
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Area of Science:

  • Pharmaceutical industry
  • Intellectual property law

Background:

  • China's pharmaceutical market is rapidly maturing.
  • This growth attracts multinational pharmaceutical producers and investors.
  • Effective patent protection is vital for drug commercialization in China.

Purpose of the Study:

  • To introduce patent prosecution and enforcement of pharmaceuticals in China.
  • To analyze the impact of amendments to the Chinese Patent Law, including the fourth amendment.
  • To highlight specific issues relevant to pharmaceutical patents.

Main Methods:

  • Review of Chinese Patent Law amendments.
  • Analysis of patentable subject matter, sufficient disclosure, and medical use claims.
  • Examination of patent term, patent linkage, regulatory exclusivity, and Bolar exemption.

Main Results:

  • Discussion of key considerations in pharmaceutical patent prosecution.
  • Identification of specific challenges and solutions in patent enforcement.
  • Analysis of the interplay between patent law and pharmaceutical regulation.

Conclusions:

  • Upcoming amendments to China's Patent Law will significantly impact pharmaceutical patent protection.
  • Strategic understanding of patentability, disclosure, and claims is essential.
  • Navigating patent term, linkage, exclusivity, and exemptions is critical for market success.