Comments (0)

Drug Regulators, EMA, Publish Overview of Comments Received on Reflection Paper, Ethanol Content in Herbal Medicinal Products

Drug Regulators, EMA, Publish Overview of Comments Received on Reflection Paper, Ethanol Content in Herbal Medicinal Products

Full Text Here

Organisations and/or individuals that commented on the draft Reflection Paper as released for
public consultation on 6 November 2008 until March 15th, 2009.
Organisations and/or individuals
1 Association of the European Self-Medication Industry (AESGP)
2 Kooperation Phytopharmaka, Germany
3 Association of Natural Medicine in Europe (ANME e.V.)
4 German Pharmaceutical Industry Association (BPI)

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulattions, rules and initiatives each month, and summarise them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

First name

Phone #1

E-mail address

Free Strategy Consultation - Biotech Pharma Regualtory

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

Comments (0)

Drug Regulators, FDA- CDER, Publish Guidance on the Assessment of Abuse Potential of Drugs

Drug Regulators, FDA- CDER, Publish Guidance on the Assessment of Abuse Potential of Drugs.

Full Text Here

This guidance is intended to assist sponsors who are developing drug products with the potential for abuse that may need to be scheduled under the Controlled Substances Act (21 U.S.C. 811(b), 811(c)). Examples of products that are addressed in this guidance include new molecular entities and new dosage forms of drug substances already controlled under the Controlled Substances Act (21 U.S.C. 812(c)). Drugs with abuse potential generally include drugs that affect the central nervous system, drugs that are chemically or pharmacologically similar to other drugs with known abuse potential, and drugs that produce psychoactive effects such as sedation, euphoria, or mood change.2

Specifically, the guidance discusses the following:

• The definition of abuse potential

• Information on submitting an abuse potential assessment, including a proposal for scheduling

• A description of what constitutes an adequate abuse potential assessment

• Information for sponsors performing an assessment, including (1) the design and conduct of appropriate studies and investigations and (2) general administrative recommendations for submitting a proposal for scheduling

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulattions, rules and initiatives each month, and summarise them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

First name

Phone #1

E-mail address

Free Strategy Consultation - Biotech Pharma Regualtory

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

Comments (0)

Twitter Weekly Updates for 2010-02-07

• Whilst a methodical process is esential, sometimes asking an expert for a gut feel can slash months of time and expense from a project! #
• Opportunities come along that give you a chance to share your expertise with a huge number of people! Take them and run with it. #
• New FDA non clinical guidlines! Video review available later today! Go to http://www.damienbove.com and click on reports! #
• Development can take longer than expected, discovery more so than development, but don't make the error or not having a plan! #

Powered by Twitter Tools

Comments (0)

Drug Regulators, FDA – CDER, Publish Guidance on Use of Mechanical Calibration of Dissolution Apparatus CGMP

Drug Regulators, FDA – CDER, Publish Guidance on Use of Mechanical Calibration of Dissolution Apparatus CGMP

Full Text Here

This guidance is intended to aid drug manufacturers (including ancillary testing laboratories) in calibrating U. S. Pharmacopeia (USP) Dissolution Apparatus 1 and 2 to help assure that critical parameters associated with the dissolution apparatus meet certain mechanical calibration (MC) tolerances. This guidance recommends that an enhanced MC procedure (such as the one recommended in this guidance) can be used as an alternative to the current Apparatus Suitability procedure for Dissolution Apparatus 1 and 2 described in USP General Chapter <711> Dissolution. Regardless of whether the enhanced MC procedure or Apparatus Suitability procedure is used, the guidance also recommends that appropriate measures be taken to control the following sources of significant variability in dissolution testing: dissolved gases, vibration, and vessel dimensions.

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulattions, rules and initiatives each month, and summarise them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

First name

Phone #1

E-mail address

Free Strategy Consultation - Biotech Pharma Regualtory

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

Comments (0)

Drug Regulators, EMEA, Release Overview of Comments Received on Draft Guidance on Clinical Evaluation of Diagnostic Agents

Drug Regulators, EMEA, Release Overview of Comments Received on Draft Guidance on Clinical Evaluation of Diagnostic Agents.

Full Text here

Comments contributed by:

1 Industry Task Force and AIPES
2 EORTC
3 GE Healthcare LTD
4 International Society for Clinical Biostatistics (ISCB)
5 MSD
6 Novartis Pharma
7 Jorgen Hilden (Dept of Biostatistics, University of Copenhagen)
8 Anabel Cortes-Blanco

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulattions, rules and initiatives each month, and summarise them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

First name

Phone #1

E-mail address

Free Strategy Consultation - Biotech Pharma Regualtory

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

Comments (1)

Drug Regulators, EMEA, Publish Guideline on Investigations of Medicinal Products in the Treatment of Epileptic Disorders

Drug Regulators, EMEA, Publish Guideline on Investigations of Medicinal Products in the Treatment of Epileptic Disorders

Full Text Here

The present document is a second revision of the existing guideline. It should be considered as general guidance on the development of medicinal products for the treatment of epileptic disorders and should be read in conjunction with other EMEA and ICH guidelines, which may apply to these conditions and patient populations.
The clinical development plan of anti-epileptic agents in partial epilepsy in the add-on setting is well-established. Current revision pays more attention to epileptic syndromes, need for studies in the paediatric population, need for monotherapy studies and other special cases.

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulattions, rules and initiatives each month, and summarise them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

First name

Phone #1

E-mail address

Free Strategy Consultation - Biotech Pharma Regualtory

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

Comments (0)

Drug Regulators EMEA, Publish Guidance on Clinical Investigations of Medicinal Products Intended for the Treatment of Glucocorticoid-Induced Osteoporosis

Drug Regulators EMEA, Publish Guidance on Clinical Investigations of Medicinal Products Intended for the Treatment of Glucocorticoid-Induced Osteoporosis

Full Text Here

Oral glucocorticoid therapy is widely used for the treatment of a variety of diseases. Approximately 1% of the population is prescribed oral glucocorticoids, and in the elderly this prevalence rises to 2.5% . The association between glucocorticoid therapy and osteoporosis is well documented and exhibits some characteristic features. Bone loss is particularly rapid in the first few months after initiation of therapy, with a slower rate of loss subsequently. Fracture risk also increases rapidly during the early months of therapy and declines after its cessation. Both cortical and cancellous bone are affected, and there is some reversibility of bone loss after cessation or reduction of therapy.
Although the severity of osteoporosis is related to the dose and duration of glucocorticoid therapy, some increase in fracture risk is seen even at daily doses of ≤7.5 mg daily for 3–6 months. Finally, the effect of glucocorticoids on bone fragility is, to some extent, independent of bone mineral density, fractures occurring at a higher bone mineral density (BMD) threshold than in postmenopausal osteoporosis (PMO). Glucocorticoid-induced osteoporosis (GIOP) and PMO share a number of characteristics with respect
to the cellular pathophysiology of bone loss. Increased bone turnover occurs in both conditions, but differs in its time course. In GIOP, an early and transient increase in bone turnover occurs against a background of low bone turnover with reduced bone formation at both tissue and cellular levels. The early increase in bone turnover in GIOP is likely to be a major contributor to bone loss and increased fracture risk within the first few months of initiating therapy and is therefore an important therapeutic target. In PMO, increased bone turnover is consistently observed over time. Both GIOP and PMO are associated with a reduction in bone formation at the cellular level, this effect
being quantitatively greater in GIOP than PMO and associated with a reduction in bone formation at the tissue level. Similar effects on cancellous bone microarchitecture have also been reported in the two conditions, depending on the dose of glucocorticoids used.

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulattions, rules and initiatives each month, and summarise them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

First name

Phone #1

E-mail address

Free Strategy Consultation - Biotech Pharma Regualtory

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

Comments (0)

Drug Regulators, EMEA, Publish Guidlines on the Investigation of Bioequivalence

Drug Regulators, EMEA, Publish Guidelines on the Investigation of Bio-equivalence

Full Text here

Two medicinal products containing the same active substance are considered bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and their bioavailabilities (rate and extent) after administration in the same molar dose lie within acceptable predefined limits. These limits are set to ensure comparable in vivo performance, i.e. similarity in terms of safety and efficacy. In bioequivalence studies, the plasma concentration time curve is generally used to assess the rate and
extent of absorption. Selected pharmacokinetic parameters and preset acceptance limits allow the final decision on bioequivalence of the tested products. AUC, the area under the concentration time curve, reflects the extent of exposure. Cmax, the maximum plasma concentration or peak exposure, and the time to maximum plasma concentration, tmax, are parameters that are influenced by absorption rate. It is the objective of this guideline to specify the requirements for the design, conduct, and evaluation of bioequivalence studies. The possibility of using in vitro instead of in vivo studies is also addressed.

Comments (0)

Drug Regulators, EMEA, Publish Draft Concept Paper on the Risk Based Approach for Advanced Therapy Medical Products

Drug Regulators, EMEA, Publish Draft Concept Paper on the Risk Based Approach for Advanced Therapy Medical Products

Full text here

The aim of the risk-based approach as defined in Annex I, part IV of Dir. 2001/83/EC is to determine the extent of data required for Marketing Authorisation Application (MAA) for an advanced therapy medicinal product (ATMP). The risk-based approach is based on the identification of risk factors inherent to the nature of the ATMP in question and associated with its quality, safety and efficacy. The risk-based approach as defined in Annex I, part IV of Dir. 2001/83/EC should be distinguished from
Risk Management, and the benefit / risk assessment in the context of a marketing authorization evaluation. The risk-based approach, when applied to the development program should be described and justified in Module 2 of the Marketing Authorisation Application dossier. The risks associated with an ATMP are highly dependent on the biological characteristics and origin of the cells, the manufacturing process, and the biological characteristics of used vectors, the properties of protein expression, non-cellular components and the specific therapeutic use of the ATMP. Thus the manufacturing process including in-process testing and batch release testing should be adequate to limit the risk of the ATMP. Nonclinical and clinical testing should further address the identified risk factors.

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulattions, rules and initiatives each month, and summarise them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

First name

Phone #1

E-mail address

Free Strategy Consultation - Biotech Pharma Regualtory

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

Comments (0)

Dedication Recognised – IDA wins award for mentor work

Damien named “Best Mentor”

I have been working on a Yorkshire Forward programme for a number of years, mentoring start up businesses from the regions universities. helping them leverage their expertise into the market place. As with all work IDA undertakes excellence is our goal and we bend over backwards to deliver it.

“The Time and Dedication Given By Damien to His Mentees and Others Shoes Outstanding Devotion”

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulattions, rules and initiatives each month, and summarise them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

First name

Phone #1

E-mail address

Free Strategy Consultation - Biotech Pharma Regualtory

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”