Drug Development Consultant & Regulatory Consultant » Diagnostic

EMA publishes guideline on bioanalytical method validation

admin — Sat, 19 Nov 2011 11:11:52 +0000

EMA has publishes guidelines to assist companies understand key elements required for validation of a bioanalytical method. It focuses on the validation geared towards quantitative concentration data used for pharmacokinetic and toxicokinetic parameter definitions. Guidance on criteria of application of these validated methods in the routine analysis of study samples from animals and humans.

excerpts from guidance

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This guideline defines key elements necessary for the validation of bioanalytical methods. The guideline focuses on the validation of the bioanalytical methods generating quantitative concentration data used for pharmacokinetic and toxicokinetic parameter determinations. Guidance and criteria are given on the application of these validated methods in the routine analysis of study samples from animal and human studies.

Measurement of drug concentrations in biological matrices (such as serum, plasma, blood, urine, and saliva) is an important aspect of medicinal product development. Such data may be required to support applications for new actives substances and generics as well as variations to authorised drug products. The results of animal toxicokinetic studies and of clinical trials, including bioequivalence studies are used to make critical decisions supporting the safety and efficacy of a medicinal drug substance or product. It is therefore paramount that the applied bioanalytical methods used are well characterised, fully validated and documented to a satisfactory standard in order to yield reliable results.
Acceptance criteria wider than those defined in this guideline may be used in special situations. This should be prospectively defined based on the intended use of the method.

FDA Publish Rules on PET Drugs GMP

admin — Fri, 23 Sep 2011 11:54:16 +0000

FDA Publish Rules on PET Drugs GMP

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This guidance is intended to help small businesses better understand and comply with the regulations issued by the Food and Drug Administration (FDA) concerning current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The guidance addresses resources, procedures, and documentation for all PET drug production facilities. In some cases, the guidance provides practical examples of methods or procedures that PET drug production facilities can use to comply with the CGMP requirements. FDA has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121).
FDA’s guidance documents, including this guidance, should not be viewed as establishing legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Section 121(c)(1)(A) of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act) directed FDA to establish CGMP requirements for PET drugs. FDA established these requirements in 21 CFR part 212

As directed by Congress in the Modernization Act, to help in developing the PET CGMP regulations and this guidance, we closely examined the operations of many PET drug producers, including not-for-profit institutions and commercial manufacturers. Since the Modernization Act became law, significant changes have occurred in PET drug production in the United States. The number of PET drug production facilities has increased, as has the number of facilities where PET scans are performed. The business of PET drug production has changed as well. Historically, PET drugs were produced by academicians and researchers at PET drug production facilities located in universities and similar not-for-profit institutions. An academically oriented PET drug production facility usually produces small amounts (a few doses per day) of a few PET drugs for on-site patient use and a larger variety of PET drugs for clinical investigation and academic research.

An increasing number of PET drug production facilities are now operated by for-profit corporate entities that contract with academic and medical institutions (many of which have not-for-profit status) to manage the production of PET drugs at those institutions. Most of these PET drugs are administered on site, although often there is some distribution to other local or regional hospitals. In addition, a growing number of independent PET drug production facilities are not affiliated with any university or hospital. These for-profit, often contractually managed, and independently operated PET drug production facilities distribute PET drugs to significantly greater numbers of patients, sometimes hundreds of miles from the production site.

Our review of PET drug production has led to the conclusion that a PET drug producer’s status as either a not-for-profit or for-profit entity has little bearing on the quality of PET drugs that it produces and distributes for administration to patients, or on the methods, facilities, and controls that a PET drug production facility needs to ensure product quality. Instead, production and CGMP differences among PET drug producers are primarily a function of the size, scope, and complexity of their production operations. We have also found that implementing certain production standards and controls can ensure the production of quality PET drugs, regardless of differences among the various PET drug production facilities. The Agency believes that the welfare of a patient undergoing a PET scan should not depend on where a particular PET drug was produced.

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FDA Publish Guidance on on In-Vitro Companion Diagnostic Devices

admin — Thu, 18 Aug 2011 09:33:56 +0000

FDA Publish Guidance On on In-Vitro Companion Diagnostic Devices

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This guidance is intended to assist (1) sponsors who are planning to develop a therapeutic product1 that depends on the use of an in vitro companion diagnostic device (or test) for its safe and effective use and (2) sponsors planning to develop an in vitro companion diagnostic device that is intended to be used with a corresponding therapeutic product.
Specifically, the guidance intends to accomplish the following:
• Define in vitro companion diagnostic device (hereafter referred to as an “IVD companion diagnostic device”)
• Explain the need for FDA oversight of IVD companion diagnostic devices
• Clarify that, in most circumstances, if use of an IVD companion diagnostic device is essential for the safe and effective use of a therapeutic product, the IVD companion diagnostic device and therapeutic product should be approved or cleared contemporaneously by FDA for the use indicated in the therapeutic product labeling
• Provide guidance for industry and FDA staff on possible premarket regulatory pathways and FDA’s regulatory enforcement policy

•Describe certain statutory and regulatory approval requirements relevant to therapeutic product labeling that stipulates concomitant use of an IVD companion diagnostic device to ensure safety and effectiveness of the therapeutic product
FDA encourages sponsors considering developing either the therapeutic or IVD companion diagnostic devices discussed in this guidance to request a meeting with both relevant device and therapeutic product review divisions to ensure that product development plans will produce sufficient data to establish the safety and effectiveness of the IVD companion diagnostic device/therapeutic product pair.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required.

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FDA Publishes Guidance on Interpretation of Chemical Action, under definition of device.

admin — Sun, 10 Jul 2011 08:47:45 +0000

FDA Publishes Guidance on Interpretation of Chemical Action, under definition of device.

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This guidance provides information about how FDA interprets the term “chemical action” in the device definition at section 201(h) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. § 321(h). The Agency is issuing a companion draft guidance Classification of Products as Drugs and Devices and Associated Product Classification Issues, (“Draft Classification Guidance”) (available on OCP’s website at http://www.fda.gov/CombinationProducts/default.htm), that addresses how FDA interprets other language in the device definition.

Section 201(h) of the FD&C Act (21 USC 321(h)) provides that the term “device” means:
… an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is–
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. (emphasis added).
Under this definition, a product (or a constituent part of a combination product)2 is not a device if it “achieve[s] its primary intended purposes through chemical action within or on the body of man or other animals.” FDA frequently receives questions from product developers concerning the Agency’s interpretation of the term “chemical action” in this definition. This guidance describes the agency’s interpretation of the term “chemical action.” However, the term “chemical action” must be read in the context of the statutory definition of “device” as a whole. As described in the Draft Classification Guidance, the determination of whether a product meets the device definition does not depend solely on whether the product exhibits “chemical action.” For example, a product that exhibits chemical action within or on the body of man may meet the device definition if the product “does not achieve its primary intended purposes through” that chemical action.

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NICE Publish Clinical Guidance on Ovarian Cancer, Recognition and Initial Management

admin — Sat, 28 May 2011 11:11:00 +0000

NICE Publish Clinical Guidance on Ovarian Cancer, Recognition and Initial Management

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These clinical guidelines review a number of clinical questions that involve the detection, diagnosis and initial management of ovarian cancer and which focus on areas of uncertainty or where there is a wide variation in clinical practice.
The clinical questions were chosen using a consultative process that involved an array of stakeholders that included patient groups, representatives from relevant professional organisations and the pharmaceutical industry.
For each chapter of the guideline, the Guideline Development Group (GDG) have made evidence-based recommendations concerning clinical practice and, where applicable, some recommendations on future research.
The GDG are pleased that the focus of many of the clinical issues relate to an early stage in the patient pathway with particular relevance to patients and their families. In particular, identifying the first tests in primary care should help ensure women are directed onto the right clinical pathway in a timely fashion.
The chair and lead clinician were aided and supported by a diverse and engaged GDG membership whose complementary skills and perspectives have been instilled in this guideline

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NICE Publish Guidance on Lung Cancer, Diagnosis and Treatment

admin — Fri, 27 May 2011 11:08:07 +0000

NICE Publish Guidance on Lung Cancer, Diagnosis and Treatment

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There are more than 39,000 new cases of lung cancer in the UK each year and more than 35,000 people die from the condition; more than for breast cancer and colorectal cancer combined. Lung cancer is now the leading cause of cancer death in women. About 90% of lung cancers are caused by smoking. Now that fewer men smoke, lung cancer deaths in men have decreased by more than a quarter in
the UK (a 27% reduction between 1971 and 2006). However, the number of women who smoke has risen and deaths from lung cancer in women have increased.
Only about 5.5% of lung cancers are currently cured. Although the cure rate is rising slowly, the rate of improvement has been slower than for other common cancers. Outcomes in the UK are worse than those in some European countries and North America. There is evidence that outcomes vary within the UK, which – among other factors – may be explained by variations in the standard of care.
This updated guideline provides recommendations for good practice in the diagnosis and treatment of non-small-cell (NSCLC) and small-cell lung cancer (SCLC).
The guideline will assume that prescribers will use a drug’s summary of product characteristics to inform decisions made with individual patients.

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EMA Publish Guidance on Novel Renal Biomarkers for Toxicity

admin — Thu, 23 Dec 2010 08:54:47 +0000

EMA Publish Guidance on Novel Renal Biomarkers for Toxicity.

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The European Medicines Agency qualification process is a new, voluntary, scientific pathway leading to either a CHMP opinion or a Scientific Advice on innovative methods or drug development tools. It includes qualification of biomarkers developed by consortia, networks, public/private partnerships, learned societies or pharmaceutical industry for a specific intended use in pharmaceuticals R&D. The HESI study evaluated four novel urinary biomarkers (BMs) of nephrotoxicity i.e. alpha-glutathione S-transferase (α-GST), μ-glutathione S-transferase (μ-GST), renal papillary antigen-1 (RPA-1) and clusterin, and compared their performance against the more traditional measurements for diagnosis of nephrotoxicity.
The data presented in this report were all generated in single and repeated dose studies conducted in male rats of two strains (Sprague-Dawley and Wistar) that are commonly used in preclinical toxicity studies. The information obtained from these studies demonstrates the potential utility of these BMs for use in rodent studies conducted to evaluate the potential target organ toxicity of compounds as part of the preclinical safety assessment of candidate medicines.

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FDA Guidance, Assay For Immunogenicity Testing of Proteins

admin — Fri, 12 Nov 2010 09:47:13 +0000

FDA Guidance, Assay For Immunogenicity Testing of Proteins

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This guidance provides recommendations to facilitate industry’s development of immune assays for assessment of the immunogenicity of therapeutic proteins during clinical trials. This document includes guidance for binding assays, neutralizing assays, and confirmatory assays. While the document does not specifically discuss the development of immune assays for animal studies, the concepts discussed are relevant to the qualification and validation of immune studies for preclinical evaluation of data.

This document does not discuss the product and patient risk factors that may contribute to immune response rates (immunogenicity).

In addition, this document does not specifically discuss how results obtained from immunoassays relate to follow-on biologic therapeutic proteins. However, elements of assay validation may affect comparability determinations of immune responses. FDA guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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FDA Draft Guidance on, Herpes Simplex Virus, Types 1 and 2 Serological Assays

admin — Fri, 15 Oct 2010 11:54:16 +0000

FDA Draft Guidance on, Herpes Simplex Virus, Types 1 and 2 Serological Assays

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This special controls guidance document was developed to support the reclassification of the herpes simplex virus types 1 and 21 (HSV 1 and 2) serological assays into class II. HSV serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.
This document does not address HSV nucleic acid amplification assays. Please contact the Division of Microbiology Devices in the Office of In Vitro Diagnostic Device Evaluation and Safety for further information on HSV 1 and/or 2 nucleic acid amplification assay submissions.
This guidance is issued in conjunction with a Federal Register final rule announcing the reclassification of HSV 1 and 2 serological assays from class III into class II and codifying the classification at 21 CFR 866.3305.
Following the effective date of a final rule classifying these devices, any firm submitting a premarket notification (510(k)) for an HSV 1 or 2 or HSV 1 and 2, serological assay will need to address the risks covered in the special control guidance document. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.

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New FDA Draft Guidance, Performance Criteria for In-Vitro Diagnostics, H.Pylori

admin — Thu, 14 Oct 2010 11:49:20 +0000

New FDA Draft Guidance, Performance Criteria for In-Vitro Diagnostics, H.Pylori

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FDA is issuing this draft guidance to provide industry and agency staff with updated recommendations concerning 510(k) submissions for various types of in vitro diagnostic devices (IVDs) intended to be used for detecting Helicobacter pylori (H. pylori). The document is a revision of the guidance entitled “Guidance for Industry and FDA Staff: Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter pylori” that was issued on September 17, 1992. It is updated to include alternate test methods, other than antibody-based detection, that are currently being used to detect H. pylori. Such methods, discussed in this document, include the stool antigen test, the urease test, blood and urine antibody tests, and the carbon-urea breath test.

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