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Related Concept Videos

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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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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

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

249
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...
249
Subviral Agents01:29

Subviral Agents

437
Subviral agents are infectious entities that resemble viruses but lack one or more viral components, such as a capsid or essential replication machinery. These agents include viroids, prions, and satellites, each possessing distinct structural and functional characteristics that influence their mode of infection and replication.Viroids are the simplest subviral agents, consisting of circular, single-stranded RNA molecules without a protein coat. They exclusively infect plants, relying entirely...
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Retroviruses02:33

Retroviruses

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Retroviruses and retrotransposons both insert copies of their genetic elements into the genome of the host cell. Thus, the viral genes are passed on when the host genome is replicated or translated. A typical retroviral DNA sequence contains 3-4 genes that encode the different proteins required for its structural assembly and function as a molecular parasite. This DNA is transcribed into a single mRNA, which is very similar in structure to conventional mRNAs, i.e., it is capped at the 5’...
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Dosage Regimen: Fixed Dose01:01

Dosage Regimen: Fixed Dose

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Fixed-dose regimens are a common approach to administer drugs to achieve and maintain desired levels of the drug in the body. In this dosing strategy, a specific amount of medication is given at regular intervals, often multiple times a day, to ensure a consistent drug concentration in the bloodstream.
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
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Related Experiment Video

Updated: Jan 4, 2026

Quantitative Structure-Activity Relationship, Activity Prediction, and Molecular Dynamics of Non-nucleotide Reverse Transcriptase Inhibitors
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Dolutegravir-rilpivirine coformulation.

Hsin-Yun Sun1, Sui-Yuan Chang2,3, Chien-Ching Hung1,4,5,6

  • 1Department of Internal Medicine.

Current Opinion in HIV and AIDS
|March 20, 2018
PubMed
Summary
This summary is machine-generated.

The combination of dolutegravir (DTG) and rilpivirine (RPV) offers an effective two-drug regimen for HIV treatment. This simplifies therapy, reduces drug exposure, and maintains viral suppression in many patients.

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Area of Science:

  • Infectious Diseases
  • Virology
  • Pharmacology

Background:

  • Prolonged life expectancy in HIV-positive individuals on combination antiretroviral therapy (cART) necessitates strategies to minimize lifelong drug exposure and associated toxicities.
  • The advent of coformulated antiretroviral agents with improved convenience, tolerability, and efficacy has shifted focus towards simplified treatment regimens.
  • Maintaining viral suppression while reducing cumulative drug exposure is a key goal in long-term HIV management.

Purpose of the Study:

  • To review current clinical experience with the novel two-drug combination of dolutegravir (DTG) and rilpivirine (RPV).
  • To elucidate potential future applications and limitations of coformulated DTG-RPV in HIV management.

Main Methods:

  • Evaluation of five observational studies and two randomized, noninferiority trials (SWORD-1 and SWORD-2).
  • Inclusion of treatment-experienced HIV-positive patients.
  • Assessment of viral load (HIV RNA) and regimen tolerability.

Main Results:

  • High rates of viral suppression (95-100%) were maintained at 24-48 weeks across studies.
  • The DTG-RPV regimen demonstrated good tolerability, with low discontinuation rates due to adverse events (0.8-7.9%).
  • Effective and safe use was observed in patients with sustained viral suppression for at least six months.

Conclusions:

  • The two-drug regimen of dolutegravir and rilpivirine is a viable option for maintaining viral suppression in select HIV-positive patients.
  • Further investigation is required for patients with a history of virological failure or antiretroviral resistance.
  • This simplified regimen holds promise for reducing long-term drug exposure and toxicity in HIV management.