Absorption

Press release - Discharge: MEPs sign off EU budget for 2022

Retrieved on: 
Thursday, April 18, 2024
European Parliament, Civil service commission, UNRWA, Financial management, Annual report, Hamas, Absorption, Face, Corruption, Next Generation EU, Risk, Female, UNICEF, S&D, MEP, Parliament, Commission, Council, Investment, European, Fraud, European Commission, WHO, Regional development, Region, Audit, UNWRA

The European Parliament on Thursday granted discharge to the Commission, all decentralised agencies and the development funds.Committee on Budgetary Control Source : © European Union, 2024 - EP

Key Points: 


The European Parliament on Thursday granted discharge to the Commission, all decentralised agencies and the development funds.Committee on Budgetary Control Source : © European Union, 2024 - EP

Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)

Retrieved on: 
Thursday, April 18, 2024
Reproduction, Particle size, Q&A, Patient, Lung, Chronic obstructive pulmonary disease, DPI, Pharmacokinetics, Child, Isocyanate, International Council, Scope, Abbreviation, Asthma, OIP, European, COPD, APSD, Absorption, Rheumatology, Risk, Draft, EMA, Safety, TE, CHMP, MDI, Pharmacodynamics, IVIVC, Documentation, Taste, Comparison, Inhalation, Charcoal, Clinical Trials Directive, The central science, Drug development, Literature, ICH, Guideline, Gastrointestinal tract, GI, Marketing, Medication package insert, Excipient, Quality, QWP, Medical device

21

Key Points: 
    • 21

      Guideline on the requirements for demonstrating
      therapeutic equivalence between orally inhaled products
      (OIP) for asthma and chronic obstructive pulmonary
      disease (COPD)

      22

      Table of contents

      23

      Executive summary ..................................................................................... 4

      24

      1.

    • Primary PK parameters to be analysed and acceptance criteria .............................. 14

      43

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      51

      6.4.

    • Definitions ........................................................................................... 18

      56

      List of Abbreviations.................................................................................. 20

      57

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      58

      Executive summary

      59

      This guideline is the 2nd revision of the CHMP Guideline formerly called ?Guideline on the requirements

      60

      for clinical documentation for orally inhaled products (OIP) including the requirements for

      61

      demonstration of therapeutic equivalence between two inhaled products for use in the treatment of

      62

      asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of

      63

      asthma in children and adolescents?.

    • It addresses the requirements for demonstration of therapeutic

      64

      equivalence (TE) between orally inhaled products containing the same active moiety(ies).

    • It is generally not recommended to aim at demonstrating TE using pharmacodynamic

      70

      or clinical endpoints as these are deemed insensitive.

    • This

      83

      guideline is directed particularly at the requirements for demonstrating TE between OIPs containing the

      84

      same active moiety(ies) and used in the management and treatment of patients with asthma and/or

      85

      COPD.

    • 86

      The guideline was first published as points to consider in 2004 and revised for the first time and

      87

      became guideline in 2009.

    • Since then, a number of Q&A documents have been published by Quality

      88

      Working Party (QWP) and former Pharmacokinetic Working Party (PKWP).

    • Scope

      93

      This document provides guidance on the requirements for demonstrating TE between OIPs, including

      94

      both, single active substance products and combination products.

    • Also, in the case that there is a need

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      98

      to confirm similarity to a product for which literature data is available (e.g., well-established use

      99

      applications), the same principles apply.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      132

      4.

    • Products for nebulisation

      177

      This guideline applies also for products for nebulisation although it is acknowledged that the

      178

      performance of these is highly dependent on the nebuliser used.

    • In vitro criteria for demonstrating TE

      206

      The test and reference products should be compared in order to conclude on TE.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      211
      212

      2.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      353

      6.2.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      392

      6.3.

    • If the
      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      432

      different strengths of the test and the reference product are not shown to be proportional in vitro, in

      433

      vivo equivalence should be demonstrated with a bracketing approach.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      471

      6.4.

    • Griffin, 1964

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      553

      which both reference product-na?ve and experienced users should be included.

    • 568

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      569

      10.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      Product strength

      Product strength may be either the delivered
      dose or the metered dose.

    • 570

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      571

      List of Abbreviations
      APSD

      Aerodynamic Particle Size Distribution

      AUC

      Area Under the Curve

      CHMP

      Committee for Medicinal Products for Human
      Use

      CI

      Confidence Interval

      Cmax

      Peak concentration

      COPD

      Chronic Obstructive Pulmonary Disease

      DPI

      Dry Powder Inhaler

      FPD

      Fine Particle Dose

      GI

      Gastrointestinal

      ICH

      International Conference on Harmonisation

      IVIVC

      In vitro in vivo correlation

      MDI

      Metered Dose Inhaler

      OIP

      Orally Inhaled Product

      PD

      Pharmacodynamic

      PK

      Pharmacokinetic

      pMDI

      Pressurised Metered Dose Inhaler

      QWP

      Quality Working Party

      SmPC

      Summary of Product Characteristics

      TE

      Therapeutic equivalence

      tmax

      Time to peak concentration

      572

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

Orphan designation: (6aR,10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydrocannabinol-9-carboxylic acid- Treatment of cystic fibrosis, 14/10/2016 Withdrawn

Retrieved on: 
Thursday, April 18, 2024
Eurostat, Diagnosis, Civil service commission, Absorption, Lower respiratory tract infection, Exercise, Cell, Infection, DSM-IV codes, Inflammation, Patient, Committee, Cystic fibrosis, Knowledge, Digestion, Regulation, Bacteria, Food, EMA, IRIS, Anti-inflammatory, Mucus, CB2, European, COMP, Pancreas, Sponsor, Ivacaftor, European Commission, Safety, CFTR, Marketing, Medicine, Pharmaceutical industry

Orphan designation: (6aR,10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydrocannabinol-9-carboxylic acid- Treatment of cystic fibrosis, 14/10/2016 Withdrawn

Key Points: 


Orphan designation: (6aR,10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydrocannabinol-9-carboxylic acid- Treatment of cystic fibrosis, 14/10/2016 Withdrawn

Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)

Retrieved on: 
Thursday, April 18, 2024
Reproduction, Particle size, Q&A, Patient, Lung, Chronic obstructive pulmonary disease, DPI, Pharmacokinetics, Child, Isocyanate, International Council, Scope, Abbreviation, Asthma, OIP, European, COPD, APSD, Absorption, Rheumatology, Risk, Draft, EMA, Safety, TE, CHMP, MDI, Pharmacodynamics, IVIVC, Documentation, Taste, Comparison, Inhalation, Charcoal, Clinical Trials Directive, The central science, Drug development, Literature, ICH, Guideline, Gastrointestinal tract, GI, Marketing, Medication package insert, Excipient, Quality, QWP, Medical device

21

Key Points: 
    • 21

      Guideline on the requirements for demonstrating
      therapeutic equivalence between orally inhaled products
      (OIP) for asthma and chronic obstructive pulmonary
      disease (COPD)

      22

      Table of contents

      23

      Executive summary ..................................................................................... 4

      24

      1.

    • Primary PK parameters to be analysed and acceptance criteria .............................. 14

      43

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      51

      6.4.

    • Definitions ........................................................................................... 18

      56

      List of Abbreviations.................................................................................. 20

      57

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      58

      Executive summary

      59

      This guideline is the 2nd revision of the CHMP Guideline formerly called ?Guideline on the requirements

      60

      for clinical documentation for orally inhaled products (OIP) including the requirements for

      61

      demonstration of therapeutic equivalence between two inhaled products for use in the treatment of

      62

      asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of

      63

      asthma in children and adolescents?.

    • It addresses the requirements for demonstration of therapeutic

      64

      equivalence (TE) between orally inhaled products containing the same active moiety(ies).

    • It is generally not recommended to aim at demonstrating TE using pharmacodynamic

      70

      or clinical endpoints as these are deemed insensitive.

    • This

      83

      guideline is directed particularly at the requirements for demonstrating TE between OIPs containing the

      84

      same active moiety(ies) and used in the management and treatment of patients with asthma and/or

      85

      COPD.

    • 86

      The guideline was first published as points to consider in 2004 and revised for the first time and

      87

      became guideline in 2009.

    • Since then, a number of Q&A documents have been published by Quality

      88

      Working Party (QWP) and former Pharmacokinetic Working Party (PKWP).

    • Scope

      93

      This document provides guidance on the requirements for demonstrating TE between OIPs, including

      94

      both, single active substance products and combination products.

    • Also, in the case that there is a need

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      98

      to confirm similarity to a product for which literature data is available (e.g., well-established use

      99

      applications), the same principles apply.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      132

      4.

    • Products for nebulisation

      177

      This guideline applies also for products for nebulisation although it is acknowledged that the

      178

      performance of these is highly dependent on the nebuliser used.

    • In vitro criteria for demonstrating TE

      206

      The test and reference products should be compared in order to conclude on TE.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      211
      212

      2.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      353

      6.2.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      392

      6.3.

    • If the
      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      432

      different strengths of the test and the reference product are not shown to be proportional in vitro, in

      433

      vivo equivalence should be demonstrated with a bracketing approach.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      471

      6.4.

    • Griffin, 1964

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      553

      which both reference product-na?ve and experienced users should be included.

    • 568

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      569

      10.

    • Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      Product strength

      Product strength may be either the delivered
      dose or the metered dose.

    • 570

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

      571

      List of Abbreviations
      APSD

      Aerodynamic Particle Size Distribution

      AUC

      Area Under the Curve

      CHMP

      Committee for Medicinal Products for Human
      Use

      CI

      Confidence Interval

      Cmax

      Peak concentration

      COPD

      Chronic Obstructive Pulmonary Disease

      DPI

      Dry Powder Inhaler

      FPD

      Fine Particle Dose

      GI

      Gastrointestinal

      ICH

      International Conference on Harmonisation

      IVIVC

      In vitro in vivo correlation

      MDI

      Metered Dose Inhaler

      OIP

      Orally Inhaled Product

      PD

      Pharmacodynamic

      PK

      Pharmacokinetic

      pMDI

      Pressurised Metered Dose Inhaler

      QWP

      Quality Working Party

      SmPC

      Summary of Product Characteristics

      TE

      Therapeutic equivalence

      tmax

      Time to peak concentration

      572

      Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and
      chronic obstructive pulmonary disease (COPD)
      EMA/CHMP/101453/2024

Hemp, Inc. Welcomes USDA Approval of GMO Hemp Strain – A Step Forward in Cannabis Biotechnology

Retrieved on: 
Tuesday, April 9, 2024
CBG, LCM, MCT, Health, USDA, Cannabinoid, Absorption, Oil, CBGA, Biotechnology, Textile, Relaxation, Paint, Risk, Coffee, Clothing, GMO, Cellulose, News, Anxiety, University, Food, Cannabis, Plant, CBDA, CBN, OTC, Restaurant, Water, Jan Vansina, THC, Paper, Agriculture

The newly approved GMO hemp variety, a breakthrough by the University of Wisconsin, is known as "Badger G".

Key Points: 
  • The newly approved GMO hemp variety, a breakthrough by the University of Wisconsin, is known as "Badger G".
  • Hemp, Inc. recognizes the pivotal role of biotechnology in the evolution of the cannabis industry.
  • This innovative strain stands to solve a pivotal problem in the hemp cultivation sector: regulatory compliance regarding THC levels.
  • This milestone in GMO hemp sets the stage for Hemp, Inc. to continue its commitment to innovation, sustainability, and legal compliance within the industry.

Biora Therapeutics Achieves Positive Interim Results for Clinical Trial of BT-600, Advancing NaviCap™ Platform Development

Retrieved on: 
Thursday, April 4, 2024
Toxicity, TNF, Absorption, Ulcerative colitis, Plasma, Tmax, SAN, Patient, UC, MD, Cmax, IBD, Clinical trial, Therapy, Safety, Pharmacokinetics, SAD, JAK, Pharmaceutical industry

SAN DIEGO, April 04, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today shared additional positive interim results from the single-ascending dose (SAD) clinical trial of BT-600, which is a drug-device combination consisting of the orally administered NaviCap™ device that delivers a proprietary liquid formulation of tofacitinib to the colon. BT-600 is being developed for the potential treatment of patients with ulcerative colitis (UC). The SAD portion of the phase 1 randomized, double-blind, placebo-controlled clinical trial tested the tolerability and pharmacokinetics of BT-600 at 5 mg and 10 mg doses of tofacitinib, compared to placebo, in healthy adult participants.

Key Points: 
  • BT-600 is being developed for the potential treatment of patients with ulcerative colitis (UC).
  • The SAD portion of the phase 1 randomized, double-blind, placebo-controlled clinical trial tested the tolerability and pharmacokinetics of BT-600 at 5 mg and 10 mg doses of tofacitinib, compared to placebo, in healthy adult participants.
  • We believe this could lead to better outcomes for patients suffering from UC.”
    According to the interim clinical data, all pharmacokinetic endpoints were met in all study participants.
  • The mean time to reach maximum concentration (Tmax) was 8–10 hours following administration of BT-600, versus 0.5-1.0 hours for conventional oral tofacitinib.

Pressure BioSciences’ Uncle Bud’s Subsidiary Reports Significant Demand for New UltraShear CBD Body Revive Spray – First Product in New “Premium Collection”

Retrieved on: 
Tuesday, April 2, 2024
Absorption, Açaí palm, Hemp, D3, UST, Business development, CBD, Human, Collection, Marketing, Plant, Commonwealth, Wellness, OTCQB, Animal, Agriculture, Pharmaceutical industry

CANTON, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- Pressure BioSciences, Inc. (OTCQB: PBIO) (“PBIO” or the “Company”), a leading innovator in high-pressure nanotechnology and a pioneer in the development of novel, broadly-enabling, pressure-based instruments and nanoemulsion products and services for the health & wellness, food & beverage, nutraceutical, cosmeceutical, and other industries, today announced that its wholly-owned Uncle Bud’s Health & Wellness consumer packaged goods subsidiary (“Uncle Bud’s”) has experienced significant sales activity in its revolutionary nanoemulsified CBD product offered in the initial launch of its highly touted “Premium Collection” of UltraShear™ processed nanoemulsion products. Click here for more info on Uncle Bud's Premium Collection.

Key Points: 
  • Click here for more info on Uncle Bud's Premium Collection.
  • The Premium Collection was an immediate success, highlighted by the unprecedented response to its initial product in the Collection - the CBD Body Revive Spray with 1200mg of Nano-CBD.
  • “Uncle Bud’s newly launched Nano-CBD Body Revive Spray, an innovative, all plant-based, organic, highly bioavailable flagship product processed using PBIO’s UltraShear platform, captured an impressive 30% conversion of Uncle Bud’s total CBD Revive Spray product revenue in March alone,” commented John Hollister, PBIO’s Director of Sales and Marketing.
  • This achievement enables PBIO to develop, manufacture, market, and sell UST-processed products into the rapidly expanding CBD marketplace.

Stryve Foods, Inc. Reports Full Year Fiscal 2023 Results

Retrieved on: 
Monday, April 1, 2024
Absorption, Growth, Acceleration, ATM, GAAP, Rationalization, Economics, SKUS

PLANO, Texas, April 01, 2024 (GLOBE NEWSWIRE) -- Stryve Foods, Inc. (“Stryve” or “the Company”) (NASDAQ: SNAX), an emerging healthy snacking platform and leader in the air-dried meat snack industry in the United States, today reports financial and operating results for the three months and twelve months ended December 31, 2023.

Key Points: 
  • Chris Boever, Chief Executive Officer, commented, “2023 marked a year of strategic transformation for Stryve, underpinned by our commitment to operational excellence and market expansion.
  • Adjusted EBITDA loss3 of ($3.4) million for the 2023 fourth quarter, compared to ($3.5) million in the prior year quarter.
  • The Company will conduct a conference call today at 4:30 p.m. Eastern Time to discuss financial and operating results for the third quarter ended September 30, 2023.
  • A telephonic replay will be available through November 28, 2023, by calling (844) 512-2921 and using passcode ID:148214195.

Inhibikase Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Activity

Retrieved on: 
Wednesday, March 27, 2024
Research, Malignancy, Absorption, PD, CSF, Imatinib, Central nervous system, International, Patient, Gastrointestinal tract, Journal, CML, NDA, Pharmacist, Traffic barrier, Cerebrospinal fluid, Insurance, D&O, Dark Ages, Therapy, Division, Blood, Bone marrow, FDA, SAD, Physician, Approximation error, Pharmaceutical industry

The Meeting Minutes confirmed that the 505(b)(2) pathway appears to be appropriate for approval of IkT-001Pro.

Key Points: 
  • The Meeting Minutes confirmed that the 505(b)(2) pathway appears to be appropriate for approval of IkT-001Pro.
  • Inhibikase will host a conference call and webcast to discuss its full-year 2023 financial results and business highlights tomorrow, March 28, 2024, at 8:00am ET.
  • The conference call can be accessed by dialing 1-877-407-0789 (United States) or 1-201-689-8562 (International) and referencing Inhibikase Therapeutics.
  • After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.

Hemp, Inc. Announces Significant Progress in Hemp Seed Meal Approval for Laying Hen Diets

Retrieved on: 
Wednesday, March 27, 2024
CBG, LCM, MCT, Health, Cannabinoid, Absorption, Oil, Vitamin, CBGA, Textile, Coalition, Relaxation, Paint, Coffee, Clothing, Cellulose, News, Anxiety, Food, Seed, Mineral, Protein, AAFCO, Cannabis, Plant, CBDA, CBN, OTC, Restaurant, Water, Ruminant, THC, Paper, Fiber crop

LAS VEGAS, NV, March 27, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- In a recent development for the agricultural and hemp industries, Hemp, Inc. (OTC: HEMP) is thrilled to announce that hemp seed meal is on the cusp of receiving approval for use in animal feed, starting with laying hen diets.

Key Points: 
  • LAS VEGAS, NV, March 27, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- In a recent development for the agricultural and hemp industries, Hemp, Inc. (OTC: HEMP) is thrilled to announce that hemp seed meal is on the cusp of receiving approval for use in animal feed, starting with laying hen diets.
  • Hemp seed meal is recognized for its rich content of vitamins, minerals, oils, and proteins, offering substantial benefits to laying hens.
  • Notably, hemp seeds are devoid of THC and CBD, components that have raised concerns in other hemp products due to potential contamination risks.
  • The Hemp Feed Coalition has ensured that any presence of these substances in hemp seed will be classified as contaminants, aligning with regulatory standards.